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Global Generic
Product Directory
   FeatureD ComPanies
         Edition 3, 2011
This is the 3rd ever edition of the
Global Generic Product Directory
We're really proud of this one. We've listened carefully to our community and made some changes. In this edition we have focused on presenting
our recommended developers. Too much choice can be paralyzing; so you will now a FEATURED DEVELOPERS section at the front. We have also
replaced 25% of the developers for one's we consider better partners for your business.
Remember that you can find the contact details for all the listed developers online and its costs you nothing to make an enquiry.
:

Find a product                    Go online to                              Make contact with
you like in the              www.genericlicensing.com                        the developer
   directory

Genericlicensing Limited has been set up to help you do more business, more effectively.
We understand the industry is changing. We understand that you want to find new value-added products for new markets. During 2011 we will
introduce new data for: Biosimilars, Super Generics & Over-the-Counter
We want to be the first place you turn to when you think about a new product
In order to better support you and your business, we are working hard to introduce more services online. You can now ask us to post WANTED
products online so the developers can come to you! Enjoy the 3rd edition, we hope you will love, cherish and share it (ie tell other people about it!)
The world of generics at your fingertips!




Asa Cox
Founder, Genericlicensing Limited
asa.cox@genericlicensing.com
skype: asa_cox



Legal: All the information contained in the directory has been provided by manufacturers and developers in good faith; Genericlicensing Limited cannot therefore guarantee the accuracy of
the data. Any consequential loss cannot be accepted as a result of any business conducted with companies listed or their products.
Contents
FEATURED DEVELOPERS
listed alphabetically
Antiobiotic                  ........................ 1
Astron                       ........................ 2 – 8
Aurobindo                    ........................ 9 – 13
BluePharma                   ........................ 14
Chanelle Medical ........................ 15 – 16
FamyCare Ltd.                ........................ 17
Farmaprojects                ........................ 18 – 20
Hikma                        ........................ 21 – 39
LogenexPharm                 ........................ 40
Lupin                        ........................ 41 – 44
Naari                        ........................ 45
Neogen                       ........................ 46
Orion                        ........................ 47
Rivopharm                    ........................ 48
Technimede                   ........................ 49 – 52
Wockhardt                    ........................ 53 – 59
Worwag                       ........................ 60




Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.
Research:
                               groups of patents.
                               Development: Approximately 50 products registered; about 20 further in
                               development.
                               Capacity: 3 manufacturing facilities – cutting-edge, computer-controlled
                               manufacturing technology – including electronic batch recording.
                               Quality:                                                            and
                               transfer and inventory coverage.
                               Responsiveness: Global supply chain management services.
                               Marketing/ Distribution: Major generic player in UK and Israel; fully



We
                               geared up to win tenders in Germany. Presence in several more markets
          target our goals.    worldwide via distribution partners.
          target our drugs.    Interested in: Contract manufacturing Contract development/Co-development
          time our delivery…     Out-licencing In-licencing Distribution EU-re-analyses/ release
                                            For more information please visit www.dexcel.com
because timing is everything                Contact: oren.weininger@dexcel.com, mohitsingh@dexcelpharma.co.uk
FEATURED
 DEVELOPERS
FEATURED DEVELOPERS                                                                                                                                    Global Generic
                                                                                                                                                                                                     Product directory




                                                                             Antibiotic - Razgrad JSC, as the successor of the largest producer of antibiotics in Bulgaria. Balkanpharma-Razgrad JSC, has over 50
                                            COMPANY NAME                     years experience in the development, production and sales of generic medicines for human and veterinary use. Antibiotic - Razgrad
                                               Antibiotic                    JSC is the majority owner of Balkanpharma-Razgrad JSC - a pharmaceutical plant with production units for finished dosage forms:
                                                                             capsules and tablets, semi-solid dosage forms, sterile liquid and dry injectable forms and also an industrial unit for lyophilized APIs.
                                                                             The portfolio of products covers various therapeutic areas with an accent on infectious diseases, ophthalmology and dermatology.
                                                    CITY                     Antibiotic - Razgrad JSC has the necessary manufacture licenses and EU GMP certification for all productions and currently exports
                                                   Razgad                    to more than 25 countries in Europe and Asia. The development strategy of the company includes the implementation of modern
                                                                             technologies and new products elaborated by its own R&D activities and is oriented towards expanding sales in international
                                                                             markets. Apart from own market presence, the company is open to out-licensing and contract manufacturing projects.
                                                 COUNTRY
                                                                             Core Sales Territory: Eastern Europe
                                                  Bulgaria                   Core Operation: API Manufacture, Finished Dose Manufacture, Sales and Marketing
                                                                             Contact Person: Ms Gergana Semova; Managing Director
                                                                                                                                    DOSSIER          DOSSIER         APPROVED             REGULATORY
MOLECULE NAME                      DOSE FORM                           DOSE STRENGTH                                                FORMAT           STATUS          COUNTRY              STATUS
Betamethasone + Gentamicin         Cream                               1 mg + 1 mg                                                  CTD              Ready           Bulgaria             PLG
Betamethasone + Gentamicin         Ointment                            1 mg + 1 mg                                                  CTD              Ready           Bulgaria             PLG
Betamethasone Valerate             Cream                               1 mg / g                                                     CTD              Ready           Bulgaria             PLG
Betamethasone Valerate             Ointment                            1 mg / g                                                     CTD              Ready           Bulgaria             PLG
Dexamethasone                      Tablet                              0.5 mg                                                       CTD              Ready           Bulgaria             PLG
Fluconazole                        Injection - Solution                2 mg/ml - 50 ml, 100 ml                                      CTD              Ready           Bulgaria             PLG
Fluconazole                        Capsule                             150 mg                                                       eCTD             In-Dev          Bulgaria
Fluconazole                        Capsule                             200 mg                                                       eCTD             In-Dev          Bulgaria
Gentamicin                         Ointment - Eye                      3 mg / g                                                     CTD              Ready           Bulgaria             PLG
Hydrocortison + Chloramphenicol    Ointment - Eye                      5 mg/g + 2 mg/g                                              CTD              Ready           Bulgaria             PLG
Levofloxacin                       Injection - Solution                5 mg/ml - 50 ml                                              CTD              Ready           Bulgaria             PLG
Levofloxacin                       Injection - Solution                5 mg/ml - 100 ml                                             CTD              Ready           Bulgaria             PLG
Levofloxacin                       Drops - Eye                         5 mg/ml - 5 ml                                               CTD              Ready           Bulgaria             PLG
Methylprednisolone                 Tablet                              4 mg                                                         CTD              Ready           Bulgaria             PLG
Methylprednisolone                 Tablet                              4 mg                                                         CTD              Ready           Bulgaria             PLG
Prednisolone                       Tablet                              5 mg                                                         CTD              Ready           Bulgaria             PLG
Prednisone                         Tablet                              5 mg                                                         CTD              Ready           Bulgaria             PLG
Tobramycin                         Ointment - Eye                      3 mg/g                                                       CTD              Ready           Bulgaria             PLG
Tobramycin + Dexamethasone         Ointment - Eye                      3 mg/g + 1 mg/g                                              CTD              Ready           Bulgaria             PLG




                                  Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.                              1
Global Generic
Product directory
                            FEATURED DEVELOPERS
                                                                                       Astron Research Ltd was established in the year 2001 with an objective to provide prompt and reliable services to Pharma sector
                                                        COMPANY NAME                   worldwide and improve the product quality with the help of Technological Innovations and Upgradations. Astron commenced its
                                                       Astron Research Ltd             UK operations in 2004 for Quality Testing and QP Release of finished formulations and API. This facility is now UK-MHRA approved.
                                                                                       Astron Research Ltd has products and technology are sold in over 50 countries, which includes European Union, US, Canada Austra-
                                                                                       lia, New Zealand, South Africa, Brazil, Mexico, Middle East & North African countries. 18 ANDAs filed in US and 38 EU CTD dossiers
                                                              CITY                     developed till 2007. Astron Research Ltd is capable of handling Formulation and Analytical Research of Solid Orals, Injectables,
                                                            Ahmedabad                  Lyophilised injectables, Topicals, Effervescent tablets, Specialty medicaments like Potent drugs & Oncology products. The company
                                                                                       has also acquired expertise in oral NDDS and Controlled Release pellets.
                                                               COUNTRY                 Core Sales Territory: Global Regulated Markets
                                                                                       Core Operation: API Manufacture, Finished Dose Manufacture, Sales and Marketing, Distribution
                                                                 India                 Contact Person: Marc Comas, VP Business Development

                                                                                                                                              DOSSIER          DOSSIER APPROVED REGULATORY
 Molecule name                          DOSE FORM                            DOSE STRENGTH                                                    FORMAT           STATUS COUNTRY STATUS
 Aceclofenac                            Tablet - Film coated                 100 mg                                                           CTD              Ready         Spain            PLG
 Alendronate / Alendronic Acid          Tablet                               5 mg, 10 mg, 70 mg                                               CTD              Ready         IOR              PLG
 Anastrozole                            Tablet - Film coated                 1 mg                                                             ANDA             Ready         IOR              NRP
 Anastrozole                            Tablet - Film coated                 1 mg                                                             CTD              Ready         IOR              PLG
 Aripiprazole                           Tablet - Dispersible (ODT)           5 mg, 10 mg, 15 mg, 30 mg                                        CTD              In-Dev        N/A              DCP slot booked
 Aripiprazole                           Tablet - Dispersible (ODT)           2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg                           ANDA             In-Dev        N/A              NRP
 Atorvastatin                           Tablet                               10 mg, 20 mg, 40 mg, 80 mg                                       CTD              In-Dev        N/A              NRP
 Atorvastatin                           Tablet                               10 mg, 20 mg, 40 mg, 80 mg                                       ANDA             In-Dev        N/A              NRP
 Bicalutamide                           Tablet - Film coated                 50 mg                                                            CTD              Ready         IOR              PLG
 Bicalutamide                           Tablet - Film coated                 50 mg                                                            ANDA             Ready         IOR              PLG
 Bisoprolol                             Tablet                               2.5 mg, 5 mg, 10 mg                                              CTD              In-Dev        N/A              DCP slot booked
 Calcium Carbonate                      Tablet - Effervescent                500 mg                                                           CTD              Ready         IOR              DCP underway
 Candesartan                            Tablet                               2 mg, 4 mg, 8 mg, 16 mg, 32 mg                                   CTD              In-Dev        N/A              NRP
 Capecitabine                           Tablet - Film coated                 150 mg, 500 mg                                                   CTD              In-Dev        N/A              DCP slot booked
 Carbidopa + Levodopa                   Tablet - SR                          50 mg + 200 mg, 25 mg + 100 mg                                   CTD              In-Dev        N/A              NRP
 Carbidopa + Levodopa                   Tablet - SR                          50 mg + 200 mg, 25 mg + 100 mg                                   ANDA             In-Dev        N/A              NRP
 Carboplatin                            Injection                            10 mg / ml (5 ml, 15 ml, 45 ml vials)                            ANDA             In-Dev        N/A              NRP
 Carboplatin                            Injection                            10 mg/ml (60 ml)                                                 CTD              Ready         IOR              NRP
 Carboplatin                            Injection                            10 mg / ml (5 ml, 15 ml, 45 ml vials)                            CTD              Ready         IOR              PLG
 Cisplatin                              Injection - Solution                 1 mg/ml (100 ml)                                                 CTD              Ready         IOR              NRP
   2          IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
ASTRON RESEARCH LTD
                                                     FEATURED DEVELOPERS                                                                                                                             Global Generic
                                                                                                                                                                                                     Product directory




                                                                                                                                                DOSSIER          DOSSIER APPROVED REGULATORY
Molecule name                   DOSE FORM                                DOSE STRENGTH                                                          FORMAT           STATUS COUNTRY STATUS
Cisplatin                       Injection - Solution                     1 mg/ml (10 ml, 25 ml, 50 ml)                                          CTD              Ready           IOR         PLG
Clopidogrel                     Tablet                                   75 mg                                                                  ANDA             In-Dev          N/A         NRP
Clopidogrel Hydrogenbisulphat   Tablet                                   75 mg                                                                  CTD              Ready           IOR         DCP underway
Clozapine                       Capsule - XR                             25 mg, 50 mg, 100 mg, 200 mg                                           CTD              In-Dev          N/A         NRP
Cytarabine                      Injection                                100 mg/ml (1 ml, 5 ml, 10 ml)                                          CTD              Ready           IOR         PLG
Darifenacin                     Tablet - SR                              7.5 mg, 15 mg                                                          CTD              In-Dev          N/A         NRP
Docetaxel                       Injection                                40 mg/ml (0.5 ml, 2 ml)                                                CTD              Ready           IOR         DCP underway
Docetaxel                       Injection                                40 mg/ml (0.2 ml, 0.8 ml)                                              ANDA             Ready           IOR         NRP
Donepezil                       Tablet                                   5 mg, 10 mg                                                            CTD              Ready           IOR         PLG
Donepezil                       Tablet                                   5 mg, 10 mg                                                            ANDA             Ready           IOR         NRP
Doxorubicin                     Injection - Solution                     2 mg/ml (5 ml, 25 ml, 100 ml)                                          CTD              Ready           UK          PLG
                                                                         150 mg, 300 mg (3 ml), 0.2 ml, 0.4 ml, 0.6 ml, 0.8 ml,
Enoxaparin                      Injection - Pre-filled syringe                                                                                  CTD              In-Dev          N/A         NRP
                                                                         1 ml
                                                                         150 mg, 300 mg (3 ml), 0.2 ml, 0.4 ml, 0.6 ml, 0.8 ml,
Enoxaparin                      Injection - Pre-filled syringe                                                                                  ANDA             In-Dev          N/A         NRP
                                                                         1 ml
Epirubicin                      Injection - Solution                     2 mg/ml (5 ml, 10 ml, 25 ml, 100 ml)                                   ANDA             In-Dev          N/A         NRP
Epirubicin                      Injection - Solution                     2 mg/ml (5 ml, 10 ml, 25 ml, 100 ml)                                   CTD              Ready           IOR         PLG
Escitalopram                    Tablet                                   10 mg, 20 mg, 40 mg                                                    CTD              Ready           IOR         PLG
Etoposide                       Injection                                20 mg/ml (12.5 ml, 25 ml)                                              ANDA             Ready           IOR         NRP
Exemestane                      Tablet                                   25 mg                                                                  CTD              Ready           IOR         PLG
Exemestane                      Tablet                                   25 mg                                                                  ANDA             In-Dev          N/A         NRP
Fesoterodine                    Tablet - SR                              4 mg, 8 mg                                                             CTD              In-Dev          N/A         NRP
Finasteride                     Tablet                                   1 mg                                                                   CTD              Ready           IOR         PLG
Finasteride                     Tablet                                   5 mg                                                                   CTD              Ready           IOR         PLG
Finasteride                     Tablet                                   1 mg                                                                   ANDA             Ready           IOR         NRP
Finasteride                     Tablet                                   5 mg                                                                   ANDA             Ready           IOR         PLG
Fludarabine                     Injection                                50 mg/ml (2ml)                                                         ANDA             Ready           IOR         NRP


                                         Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.                     3
Global Generic
Product directory
                             FEATURED DEVELOPERS                                                                                                      ASTRON RESEARCH LTD


                                                                                                                                               DOSSIER          DOSSIER APPROVED REGULATORY
 Molecule name                           DOSE FORM                            DOSE STRENGTH                                                    FORMAT           STATUS COUNTRY STATUS
 Fluorouracil (5FU)                      Injection                            50 mg/ml (5 ml, 10 ml, 20 ml, 100 ml)                            ANDA             In-Dev   N/A       NRP
 Fluorouracil (5FU)                      Injection                            50 mg/ml (5 ml, 10 ml, 20 ml, 100 ml)                            CTD              Ready    IOR       PLG
 Fluvastatin                             Tablet - SR                          80 mg                                                            CTD              In-Dev   N/A       DCP slot booked
 Fluvastatin                             Tablet - SR                          80 mg                                                            ANDA             In-Dev   N/A       NRP
 Gabapentin                              Tablet - Film coated                 600 mg, 800 mg                                                   CTD              Ready    Finland   PLG
 Gemcitabine                             Injection - Ready-to-use             0.2 g, 1 g, 1.5 g, 2 g                                           CTD              In-Dev   N/A       DCP underway
 Gemcitabine                             Injection - Powder                   2000 mg                                                          CTD              Ready    IOR       DCP slot booked
 Gemcitabine                             Injection - Powder                   200 mg, 1000 mg                                                  CTD              Ready    IOR       PLG
 Gemcitabine                             Injection - Powder                   200 mg, 1000 mg, 2000 mg                                         ANDA             Ready    IOR       NRP
 Glimepiride                             Tablet                               1 mg, 2 mg, 3 mg, 4 mg                                           CTD              Ready    IOR       PLG
 Glimepiride                             Tablet                               1 mg, 2 mg, 4 mg                                                 ANDA             Ready    IOR       PLG
 Imatinib                                Tablet                               100 mg, 400 mg                                                   CTD              In-Dev   N/A       DCP slot booked
 Irbesartan                              Tablet                               75 mg, 150 mg, 300 mg                                            CTD              Ready    IOR       PLG
 Irinotecan                              Injection                            20 mg/ml (2 ml, 5 ml)                                            CTD              Ready    IOR       PLG
 Irinotecan                              Injection                            20 mg/ml (2 ml, 5 ml)                                            ANDA             In-Dev   N/A       NRP
 Irinotecan                              Injection                            20 mg/ml (25 ml)                                                 CTD              Ready    IOR       NRP
 Iron Sucrose                            Injection                            20 mg/ml (5 ml vial)                                             ANDA             In-Dev   N/A       NRP
 Lansoprazole                            Tablet - Enteric coated              15 mg, 30 mg                                                     CTD              In-Dev   N/A       DCP slot booked
 Lansoprazole                            Capsule - SR                         15 mg, 30 mg                                                     ANDA             In-Dev   N/A       NRP
 Letrozole                               Tablet - Film coated                 2.5 mg                                                           CTD              Ready    IOR       PLG
 Letrozole                               Tablet - Film coated                 2.5 mg                                                           ANDA             Ready    IOR       PLG
 Levetiracetam                           Tablet                               250 mg, 500 mg, 750 mg, 1000 mg                                  CTD              Ready    IOR       DCP slot booked
 Levetiracetam                           Tablet                               250 mg, 500 mg, 750 mg, 1000 mg                                  ANDA             Ready    N/A       Approved
 Levodopa + Carbidopa                    Tablet                               100 mg + 25 mg, 200 mg + 50 mg                                   CTD              Ready    N/A       DCP underway
 Levodopa + Carbidopa                    Tablet                               100 mg + 25 mg, 200 mg + 50 mg                                   ANDA             In-Dev   N/A       NRP
 Levofloxacin                            Tablet                               250 mg, 500 mg                                                   CTD              Ready    N/A       DCP underway
 Levothyroxine                           Tablet                               25/50/75/88/100/112/125/137/150/175/200/300 µg                   CTD              In-Dev   N/A       NRP

   4           IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
ASTRON RESEARCH LTD
                                               FEATURED DEVELOPERS                                                                                                                             Global Generic
                                                                                                                                                                                               Product directory




                                                                                                                                          DOSSIER          DOSSIER APPROVED REGULATORY
Molecule name             DOSE FORM                                DOSE STRENGTH                                                          FORMAT           STATUS COUNTRY STATUS
Levothyroxine             Tablet                                   25/50/75/88/100/112/125/137/150/175/200/300 µg                         ANDA             In-Dev          N/A         NRP
Losartan Potassium        Tablet - Film coated                     25 mg, 50 mg, 100 mg                                                   CTD              Ready           IOR         PLG
Meloxicam                 Injection                                5 mg/ml (10 ml)                                                        ANDA             Ready           IOR         NRP
Methotrexate              Injection                                5 mg/ml (3 ml)                                                         CTD              Ready           Sweden      PLG
Methotrexate              Injection                                25 mg/ml (2ml)                                                         CTD              Ready           IOR         NRP
Methotrexate              Injection                                100 mg/ml (5 ml, 10 ml)                                                CTD              Ready           IOR         NRP
Methotrexate              Injection                                5 mg/ml (3 ml)                                                         ANDA             In-Dev          N/A         NRP
Methotrexate              Injection                                25 mg/ml (2ml)                                                         ANDA             In-Dev          N/A         NRP
Methotrexate              Injection                                100 mg/ml (5 ml, 10 ml)                                                ANDA             In-Dev          N/A         NRP
Methotrexate              Injection                                25 mg/ml (20 ml. 40 ml)                                                CTD              Ready           IOR         NRP
Metoprolol Succinate      Tablet - SR                              25 mg, 50 mg, 100 mg, 200 mg                                           ANDA             Ready           IOR         NRP
Midazolam                 Injection                                1 mg/ml (5 ml)                                                         CTD              Ready           IOR         PLG
Midazolam                 Injection                                5 mg/ml (1 ml, 3 ml, 10 ml)                                            CTD              Ready           IOR         PLG
Mitomycin                 Injection - Powder                       5 mg, 20 mg, 40 mg                                                     ANDA             Ready           IOR         PLG
Mitomycin                 Injection - Powder                       0.2 mg/vial                                                            ANDA             In-Dev          N/A         NRP
Mitoxantrone              Injection                                2 mg/ml (10 ml, 12.5 ml, 15 ml)                                        ANDA             In-Dev          N/A         NRP
Montelukast               Tablet - Chewable                        4 mg, 5 mg                                                             CTD              Ready           Europe      PLG
Montelukast               Tablet - Film coated                     10 mg                                                                  CTD              In-Dev          N/A         DCP underway
Montelukast               Tablet - Film coated                     10 mg                                                                  ANDA             In-Dev          N/A         NRP
Mycophenelate Mofetil     Injection - Powder                       500 mg                                                                 CTD              In-Dev          N/A         DCP underway
Mycophenelate Mofetil     Capsule - Hard gel                       250 mg                                                                 ANDA             Ready           IOR         PLG
Mycophenelate Mofetil     Capsule - Hard gel                       250 mg                                                                 CTD              Ready           IOR         PLG
Mycophenelate Mofetil     Tablet - Film coated                     500 mg                                                                 CTD              Ready           IOR         PLG
Mycophenelate Mofetil     Tablet - Film coated                     500 mg                                                                 ANDA             Ready           IOR         PLG
Naltrexone                Tablet                                   50 mg                                                                  CTD              Ready           UK          PLG
Naltrexone                Tablet                                   50 mg                                                                  ANDA             Ready           IOR         NRP
Olanzapine                Tablet                                   2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg                              CTD              Ready           IOR         DCP underway


                                   Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.                     5
Global Generic
Product directory
                             FEATURED DEVELOPERS                                                                                                      ASTRON RESEARCH LTD


                                                                                                                                               DOSSIER          DOSSIER APPROVED REGULATORY
 Molecule name                           DOSE FORM                            DOSE STRENGTH                                                    FORMAT           STATUS COUNTRY STATUS
 Olanzapine                              Tablet                               2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg                        ANDA             In-Dev   N/A     NRP
 Olmasertan                              Tablet                               5 mg, 10 mg, 20 mg, 40 mg                                        CTD              In-Dev   N/A     DCP slot booked
 Omeprazole                              Capsule                              20 mg, 40 mg                                                     CTD              In-Dev   N/A     DCP slot booked
 Ondansetron                             Injection                            2 mg/ml (2 ml, 4 ml)                                             CTD              Ready    IOR     PLG
 Ondansetron                             Injection                            2 mg/ml (2 ml, 4 ml)                                             ANDA             In-Dev   N/A     NRP
 Orlistat                                Capsule                              60 mg                                                            CTD              In-Dev   N/A     NRP
 Oxaliplatin                             Injection - Powder                   50 mg, 100 mg                                                    CTD              Ready    IOR     PLG
 Oxaliplatin                             Injection - Ready-to-use             50 mg, 100 mg                                                    CTD              Ready    IOR     PLG
 Oxaliplatin                             Injection - Ready-to-use             5 mg/ml (10 ml, 20 ml, 40 ml)                                    ANDA             In-Dev   N/A     NRP
 Oxaliplatin                             Injection - Ready-to-use             200 mg                                                           CTD              Ready    IOR     NRP
 Oxcarbazepine                           Capsule - XR                         300 mg, 600 mg                                                   CTD              In-Dev   N/A     NRP
 Oxybutynin                              Tablet - SR                          5 mg, 10 mg, 15 mg                                               CTD              In-Dev   N/A     NRP
 Paclitaxel                              Injection - Solution                 6 mg/ml (5 ml, 16.7 ml, 50 ml)                                   CTD              Ready    IOR     DCP underway
 Paclitaxel                              Injection - Solution                 6 mg/ml (5 ml, 16.7 ml, 50 ml)                                   ANDA             Ready    IOR     NRP
 Paliperidone                            Tablet - SR                          1.5 mg, 3 mg, 6 mg, 9 mg                                         ANDA             In-Dev   N/A     NRP
 Pantoprazole Sodium                     Tablet - Enteric coated              20 mg, 40 mg                                                     CTD              In-Dev   N/A     DCP slot booked
 Pantoprazole Sodium                     Tablet - SR                          20 mg, 40 mg                                                     ANDA             In-Dev   N/A     NRP
 Paracetamol                             Tablet - Effervescent                500 mg, 1000 mg                                                  CTD              Ready    IOR     PLG
 Pemetrexed                              Injection - Powder                   100 mg, 500 mg                                                   CTD              In-Dev   N/A     DCP slot booked
 Pioglitazone                            Tablet                               15 mg, 30 mg, 45 mg                                              CTD              Ready    IOR     DCP slot booked
 Pioglitazone                            Tablet                               15 mg, 30 mg, 45 mg                                              ANDA             Ready    IOR     NRP
 Pramipexole                             Tablet                               125 µg, 250 µg, 500 µg, 1000 µg, 1500 µg                         CTD              In-Dev   N/A     NRP
 Pramipexole                             Tablet                               125 µg, 250 µg, 500 µg, 1000 µg, 1500 µg                         ANDA             In-Dev   N/A     NRP
 Pravastatin                             Tablet                               10 mg, 20 mg, 40 mg                                              CTD              Ready    IOR     PLG
 Pravastatin                             Tablet                               10 mg, 20 mg, 40 mg, 80 mg                                       ANDA             In-Dev   N/A     NRP
                                                                              25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225
 Pregabalin                              Capsule                                                                                               CTD              In-Dev   N/A     NRP
                                                                              mg, 300 mg


   6           IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
ASTRON RESEARCH LTD
                                               FEATURED DEVELOPERS                                                                                                                              Global Generic
                                                                                                                                                                                                Product directory




                                                                                                                                          DOSSIER          DOSSIER APPROVED REGULATORY
Molecule name             DOSE FORM                                DOSE STRENGTH                                                          FORMAT           STATUS COUNTRY STATUS
Quetiapine                Tablet - SR                              200 mg, 300 mg, 400 mg                                                 CTD              Ready           IOR         DCP underway
Quetiapine                Tablet - IR                              25 mg, 100 mg, 150 mg, 200 mg, 300 mg                                  CTD              Ready           IOR         DCP underway
Quetiapine                Tablet - SR                              50 mg                                                                  CTD              In-Dev          N/A         DCP slot booked
Quetiapine                Tablet - IR                              25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg                           ANDA             In-Dev          N/A         NRP
Quetiapine                Tablet - SR                              150 mg, 200 mg, 300 mg, 400 mg                                         ANDA             Ready           IOR         NRP
Quetiapine                Tablet - SR                              50 mg                                                                  ANDA             In-Dev          N/A         NRP
Quinine Sulphate          Tablet                                   300 mg                                                                 CTD              Ready           IOR         NRP
Rabeprazole               Tablet                                   10 mg, 20 mg                                                           CTD              In-Dev          N/A         DCP slot booked
Ramipril                  Tablet                                   1.25 mg, 2.5 mg, 5 mg, 10 mg                                           CTD              In-Dev          N/A         DCP underway
Ranitidine                Tablet - Effervescent                    150 mg, 300 mg                                                         CTD              Ready           IOR         PLG
Ranitidine                Tablet - Effervescent                    75 mg                                                                  CTD              In-Dev          N/A         NRP
Rasagiline                Tablet                                   1 mg                                                                   CTD              In-Dev          N/A         NRP
Repaglinide               Tablet                                   0.5 mg, 1 mg, 2 mg                                                     CTD              In-Dev          N/A         DCP slot booked
Risperidone               Tablet - Film coated                     0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, 6 mg                                   CTD              Ready           IOR         PLG
Ropinirole                Tablet - Film coated                     0.25 mg, 0.5 mg, 1 mg, 2 mg, 5 mg                                      CTD              Ready           IOR         PLG
Sildenafil                Tablet                                   25 mg, 50 mg, 100 mg                                                   CTD              Ready           IOR         DCP underway
Simvastatin               Tablet - Film coated                     10 mg, 20 mg, 40 mg, 80 mg                                             ANDA             Ready           IOR         PLG
Sirolimus                 Tablet                                   1 mg, 2 mg                                                             CTD              In-Dev          N/A         DCP slot booked
Sodium Valproate          Tablet - SR                              300 mg, 500 mg                                                         CTD              In-Dev          N/A         NRP
Solifenacin succinate     Tablet - Film coated                     5 mg, 10 mg                                                            CTD              In-Dev          N/A         DCP slot booked
Sumatriptan Succinate     Tablet                                   50 mg, 100 mg                                                          CTD              Ready           Finland     PLG
Tacrolimus                Capsule - Hard gel                       0.5 mg, 1 mg, 5 mg                                                     CTD              Ready           IOR         DCP underway
Tacrolimus                Capsule - Hard gel                       0.5 mg, 1 mg, 5 mg                                                     ANDA             Ready           IOR         NRP
Tacrolimus                Ointment                                 0.01%, 0.03%                                                           CTD              In-Dev          N/A         NRP
Tadalafil                 Tablet                                   2.5 mg, 5 mg, 10 mg, 20 mg                                             CTD              In-Dev          N/A         DCP slot booked
Telmisartan               Tablet                                   20 mg, 40 mg, 80 mg                                                    CTD              In-Dev          N/A         DCP slot booked
Telmisartan + HCTZ        Tablet                                   40 mg + 12.5 mg, 80 mg + 12.5 mg                                       CTD              In-Dev          N/A         NRP

                                   Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.                      7
Global Generic
Product directory
                            FEATURED DEVELOPERS                                                                                                      ASTRON RESEARCH LTD


                                                                                                                                              DOSSIER          DOSSIER APPROVED REGULATORY
 Molecule name                          DOSE FORM                            DOSE STRENGTH                                                    FORMAT           STATUS COUNTRY STATUS
 Temozolomide                           Capsule - Hard gel                   5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg                      CTD              Ready    IOR     NRP
 Temozolomide                           Capsule - Hard gel                   5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg                      ANDA             Ready    IOR     NRP
 Terazosin                              Tablet                               1 mg, 2 mg, 5 mg, 10 mg                                          CTD              Ready    IOR     PLG
 Tolterodine                            Capsule - XR                         2 mg, 4 mg                                                       CTD              In-Dev   N/A     DCP slot booked
 Tolterodine                            Capsule - SR                         4 mg                                                             ANDA             In-Dev   N/A     NRP
 Tolterodine                            Tablet - IR                          1 mg, 2 mg                                                       CTD              Ready    IOR     PLG
 Topiramate                             Tablet                               25 mg, 50 mg, 100 mg, 200 mg                                     CTD              Ready    IOR     PLG
 Topotecan                              Injection - Powder                   4 mg                                                             CTD              Ready    IOR     PLG
 Topotecan                              Injection - Ready-to-use             4 mg                                                             CTD              In-Dev   N/A     NRP
 Vardenafil                             Tablet - Film coated                 5 mg, 10 mg, 20 mg                                               CTD              In-Dev   N/A     NRP
 Vitamin C                              Tablet - Effervescent                500 mg                                                           CTD              In-Dev   N/A     NRP
 Voriconazole                           Tablet                               50/200 mg                                                        CTD              In-Dev   N/A     NRP
                                                                             1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg,
 Warfarin                               Tablet                                                                                                CTD              In-Dev   N/A     DCP slot booked
                                                                             10 mg
                                                                             1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg,
 Warfarin                               Tablet                                                                                                ANDA             Ready    IOR     NRP
                                                                             10 mg
 Ziprasidone                            Capsule                              20 mg, 40 mg, 60 mg, 80 mg                                       CTD              In-Dev   N/A     NRP




   8          IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
Global Generic
Product directory
                            FEATURED DEVELOPERS
                                                                                       Aurobindo Pharma was born of a vision. The company is the market leader in semi-synthetic penicillin drugs. It has a presence in
                                                         COMPANY NAME                  key therapeutic segments like SSPs, cephalosporins, antivirals, CNS, cardiovascular, gastroenterology, etc. Over the years, the Au-
                                                           Aurobindo                   robindo Pharma has evolved into a knowledge driven company. It is R&D focused, has a multi-product portfolio with multi-country
                                                                                       manufacturing facilities, and is becoming a marketing conglomerate across the world.
                                                                                       Aurobindo Pharma created a name for itself in the manufacture of bulk actives, its area of core competence. The formulation busi-
                                                                CITY                   ness is systematically organized with a divisional structure, and has a focused team for each key international market. Aurobindo
                                                              Hyderabad                believes in gaining volume and market share in every business/segment it enters.

                                                                                       Core Sales Territory: Global Regulated Markets
                                                              COUNTRY                  Core Operation: API Manufacture, Finished Dose Manufacture, Sales and Marketing, Distribution
                                                                India                  Contact Person: Mr Vivek Shah; Business Support Manager


                                                                                                                                              DOSSIER          DOSSIER APPROVED                     REGULATORY
 MOLECULE NAME                                  DOSE FORM                                  DOSE STRENGTH                                      FORMAT           STATUS COUNTRY                       STATUS
 Alendronate sodium                             Tablet                                      10, 70 mg;                                        CTD              Ready         IOR                    IOR
 Alendronate sodium + Cholecalciferol           Tablet                                     70mg+2800IU, 70mg+5600IU                           CTD              Ready         IOR                    IOR
 Alfuzosin HCl                                  Tablet - XR                                10 mg                                              CTD              Ready         IOR                    IOR
 Alfuzosin HCl                                  Tablet                                     2.5mg                                              CTD              Ready         IOR                    IOR
 Alprazolam                                     Tablet                                      0.25,0.5,1mg                                      CTD              Ready         IOR                    IOR
 Amisulpride                                    Tablet                                     50, 100, 200, 400mg                                CTD              Ready         IOR                    IOR
 Amlodipine                                     Tablet                                     5&10 mg;                                           CTD              Ready         IOR                    IOR
 Amlodipine                                     Capsule                                    5,10mg                                             CTD              Ready         IOR                    IOR
 Amoxicillin                                    Capsule                                    250,500mg                                          CTD              Ready         IOR                    IOR
 Amoxicillin                                    Tablet                                     1G                                                 CTD              Ready         IOR                    IOR
 Amoxicillin + Clavulanic Acid                  PFOS                                       125+31.25, 250+62.5 mg: Sugar free                 CTD              Ready         IOR                    IOR
 Azithromycin                                   Suspension - Oral                          200mg/5ml, 500mg/5ml*                              CTD              Ready         IOR                    IOR
 Azithromycin                                   Tablet                                     250/500/600mg                                      CTD              Ready         IOR                    IOR
 Benazepril                                     Tablet                                     5, 10, 20mg                                        CTD              Ready         IOR                    IOR
 Betahistine                                    Tablet                                     8,16,24mg                                          CTD              Ready         IOR                    IOR
 Bisoprolol Fumarate                            Tablet                                      1.25,2.5,3.75,5mg                                 CTD              Ready         IOR                    IOR
 Carvedilol                                     Tablet                                     3.125,6.25,12.5,25mg                               CTD              Ready         IOR                    IOR
 Cefixime                                       Suspension - Oral                          100mg/5ml                                          CTD              Ready         IOR                    IOR
 Cefixime                                       Tablet                                     200,400mg                                          CTD              Ready         IOR                    IOR


   9          IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
AUROBINDO PHARMA
                                           FEATURED DEVELOPERS                                                                                                                           Global Generic
                                                                                                                                                                                         Product directory




                                                                                                                                      DOSSIER          DOSSIER APPROVED            REGULATORY
MOLECULE NAME                   DOSE FORM                                      DOSE STRENGTH                                          FORMAT           STATUS COUNTRY              STATUS
Cefpodoxime Proxetil            Suspension - Oral                              40mg/5ml                                               CTD              Ready           IOR         IOR
Cefpodoxime Proxetil            Tablet                                         100, 200mg                                             CTD              Ready           IOR         IOR
Cefprozil                       PFOS                                           125, 250mg/5ml                                         CTD              Ready           IOR         IOR
Cefprozil                       Tablet                                         250, 500mg                                             CTD              Ready           IOR         IOR
Cefuroxime Axetil               Tablet                                         250,500mg; UK, PL 125 mg                               CTD              Ready           IOR         IOR
Cephalexin                      Capsule                                        250,500mg                                              CTD              Ready           IOR         IOR
Cetirizine HCl                  Tablet                                         10 mg                                                  CTD              Ready           IOR         IOR
Ciprofloxacin HCl               Tablet                                         250,500,750mg                                          CTD              Ready           IOR         IOR
Citalopram HBr                  Tablet                                         10,20,40 mg                                            CTD              Ready           IOR         IOR
Clarithromycin                  Tablet                                         250,500mg                                              CTD              Ready           IOR         IOR
Clindamycin HCl                 Capsule                                        150, 300 mg                                            CTD              Ready           IOR         IOR
Cloxacillin                     Capsule                                        250, 500mg                                             CTD              Ready           IOR         IOR
Didanosine                      Capsule - EC                                   200250400                                              CTD              Ready           IOR         IOR
Doxazosin Mesylate              Tablet                                         1,2,4,8mg                                              CTD              Ready           IOR         IOR
Enalapril Maleate               Tablet                                         5, 10, 20mg                                            CTD              Ready           IOR         IOR
Esomeprazole Magnesium          Tablet - DR                                    20,40mg                                                CTD              Ready           IOR         IOR
Finasteride                     Tablet                                         5mg                                                    CTD              Ready           IOR         IOR
Finasteride                     Tablet                                         1mg                                                    CTD              Ready           IOR         IOR
Fluconazole                     Suspension - Oral                              50, 200 mg / 5ml,                                      CTD              Ready           IOR         IOR
Fluconazole                     Capsule                                        50,100,150,200mg                                       CTD              Ready           IOR         IOR
Fluoxetine HCl                  Solution - Oral                                20mg/5ml                                               CTD              Ready           IOR         IOR
Fluoxetine HCl                  Capsule                                        10, 20, 40, 60mg                                       CTD              Ready           IOR         IOR
Fosinopril + HCTZ               Tablet                                         20+12.5mg                                              CTD              Ready           IOR         IOR
Fosinopril Sodium               Tablet                                         10, 20 mg                                              CTD              Ready           IOR         IOR
Furosemide                      Tablet                                         20, 40mg                                               CTD              Ready           IOR         IOR
Gabapentin                      Capsule                                        100,300,400mg                                          CTD              Ready           IOR         IOR
Gabapentin                      Tablet                                         600,800mg;                                             CTD              Ready           IOR         IOR


                               Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.                   10
Global Generic
Product directory
                            FEATURED DEVELOPERS                                                                                                      AUROBINDO PHARMA


                                                                                                                                              DOSSIER          DOSSIER APPROVED   REGULATORY
 MOLECULE NAME                                  DOSE FORM                                  DOSE STRENGTH                                      FORMAT           STATUS COUNTRY     STATUS
 Glimepiride                                    Tablet                                     1,2,3,4mg                                          CTD              Ready   IOR        IOR
 Lamotrigine                                    Tablet                                      25, 50, 100, 200 mg                               CTD              Ready   IOR        IOR
 Lamotrigine                                    Tablet - Chewable                           2, 5, 25, 50, 100, 200mg                          CTD              Ready   IOR        IOR
 Lansoprazole                                   Capsule - DR                                15,30mg                                           CTD              Ready   IOR        IOR
 Lansoprazole                                   Tablet - Dispersible (ODT)                 15, 30 mg                                          CTD              Ready   IOR        IOR
 Levetiracetam                                  Solution - Oral                            100mg/ml                                           CTD              Ready   IOR        IOR
 Levetiracetam                                  Tablet                                     250,500,750mg, 1g                                  CTD              Ready   IOR        IOR
 Lisinopril                                     Tablet                                      5, 10, 20, 30, 40 mg                              CTD              Ready   IOR        IOR
 Lisinopril + HCTZ                              Tablet                                      10+12.5,20+12.5mg                                 CTD              Ready   IOR        IOR
 Losartan Potassium                             Tablet                                     12.5, 25, 50, 100mg                                CTD              Ready   IOR        IOR
 Losartan Potassium + HCTZ                      Tablet                                      50+12.5, 100+25mg                                 CTD              Ready   IOR        IOR
 Meloxicam                                      Tablet                                     7.5,15mg                                           CTD              Ready   IOR        IOR
 Metformin HCl                                  Tablet                                     500,850,1000mg                                     CTD              Ready   IOR        IOR
 Metoprolol Tartrate                            Tablet                                      50,100 & 200MG                                    CTD              Ready   IOR        IOR
 Mirtazapine                                    Tablet - Dispersible (ODT)                 : 15, 30, 45mg                                     CTD              Ready   IOR        IOR
 Mirtazapine Plain                              Tablet                                      15,30,45mg                                        CTD              Ready   IOR        IOR
 Modafinil                                      Tablet                                     100 mg                                             CTD              Ready   IOR        IOR
 Moxifloxacin HCl                               Tablet                                     400mg                                              CTD              Ready   IOR        IOR
 Naproxen                                       Tablet                                     250, 500mg                                         CTD              Ready   IOR        IOR
 Naproxen Sodium                                Tablet                                      550mg                                             CTD              Ready   IOR        IOR
 Nevirapine                                     TFOS                                       50 mg PEPFAR PED                                   CTD              Ready   IOR        IOR
 Nevirapine                                     Tablet                                     200mg                                              CTD              Ready   IOR        IOR
 Nitrofurantoin                                 Capsule                                    100mg (75mg MH + 25 Mcryst)                        CTD              Ready   IOR        IOR
 Olanzapine                                     Tablet                                     2.5, 5, 7.5, 10, 15, 20 mg                         CTD              Ready   IOR        IOR
 Olanzapine                                     Tablet - Dispersible (ODT)                 5,10,15,20 mg                                      CTD              Ready   IOR        IOR
 Omeprazole                                     Pellet - DR                                10,20,40mg                                         CTD              Ready   IOR        IOR
 Ondansetron                                    Tablet - Dispersible (ODT)                 4,8mg                                              CTD              Ready   IOR        IOR


   11         IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
AUROBINDO PHARMA
                                          FEATURED DEVELOPERS                                                                                                                           Global Generic
                                                                                                                                                                                        Product directory




                                                                                                                                     DOSSIER          DOSSIER APPROVED            REGULATORY
MOLECULE NAME                  DOSE FORM                                      DOSE STRENGTH                                          FORMAT           STATUS COUNTRY              STATUS
Ondansetron HCl                Tablet                                         4,8 mg                                                 CTD              Ready           IOR         IOR
Pantoprazole sodium            Tablet - DR                                    20,40mg                                                CTD              Ready           IOR         IOR
Paroxetine HCl                 Tablet                                         20,30mg                                                CTD              Ready           IOR         IOR
Pen V potassium                Tablet                                         250, 800, 1000mg, 1.0 m.u, 1.5m.u                      CTD              Ready           IOR         IOR
Perindopril Erbumine           Tablet                                         2,4,8mg                                                CTD              Ready           IOR         IOR
Phenytoin Sodium               Tablet                                         EU: 50,100mg                                           CTD              Ready           IOR         IOR
Pioglitazone                   Tablet                                         15,30,45mg                                             CTD              Ready           IOR         IOR
Pramipexole                    Tablet                                         0.125, 0.25, 0.5, 1, 1.5 mg                            CTD              Ready           IOR         IOR
Pravastatin                    Tablet                                         10, 20, 40mg                                           CTD              Ready           IOR         IOR
Quinapril HCl                  Tablet                                         5,10,20,40mg                                           CTD              Ready           IOR         IOR
Quinapril HCl + HTZ            Tablet                                         10+12.5, 20+12.5, 20+25 mg                             CTD              Ready           IOR         IOR
Ramipril                       Capsule                                        1.25,2.5,5,10mg:                                       CTD              Ready           IOR         IOR
Ramipril                       Tablet                                         1.25, 2.5, 5,10mg;                                     CTD              Ready           IOR         IOR
Ranitidine HCl                 Syrup                                          15mg/1ml                                               CTD              Ready           IOR         IOR
Repaglinide                    Tablet                                         0.5, 1, 2 mg                                           CTD              Ready           IOR         IOR
Ribavirin                      Capsule                                        200mg                                                  CTD              Ready           IOR         IOR
Ribavirin                      Tablet                                         200, 400mg                                             CTD              Ready           IOR         IOR
Risedronate                    Tablet                                         5, 30, 35mg                                            CTD              Ready           IOR         IOR
Risedronate Sodium+Calcium
                               Tablet                                         35+500mg;                                              CTD              Ready           IOR         IOR
carbonate
Risperidone                    Tablet                                         0.5,1,2,3,4,6mg,                                       CTD              Ready           IOR         IOR
Risperidone                    Solution - Oral                                1mg/ml                                                 CTD              Ready           IOR         IOR
Rizatriptan                    Tablet                                         5, 10mg                                                CTD              Ready           IOR         IOR
Rizatriptan                    Tablet - Dispersible (ODT)                     5, 10mg                                                CTD              Ready           IOR         IOR
Ropinirole                     Tablet                                         0.25,0.5,1,2,5 mg                                      CTD              Ready           IOR         IOR
Rosuvastatin Ca                Tablet                                         5, 10, 20, 40mg                                        CTD              Ready           IOR         IOR
Sertraline HCl                 Tablet                                         50,100mg                                               CTD              Ready           IOR         IOR


                              Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.                   12
Global Generic
Product directory
                           FEATURED DEVELOPERS                                                                                               DOSSIER
                                                                                                                                                    AUROBINDO PHARMA

                                                                                                                                                              DOSSIER APPROVED   REGULATORY
 MOLECULE NAME                                 DOSE FORM                                  DOSE STRENGTH                                      FORMAT           STATUS COUNTRY     STATUS
 Sertraline HCl                                Tablet                                     50,100mg                                           CTD              Ready   IOR        IOR
 Sertraline HCl                                Capsule                                    25,50,100mg                                        CTD              Ready   IOR        IOR
 Simvastatin                                   Tablet                                     5,10,20,30,40,60,80mg;                             CTD              Ready   IOR        IOR
 Sotalol                                       Tablet                                     40, 80, 160mg                                      CTD              Ready   IOR        IOR
 Sumatriptan Succinate                         Tablet                                     50,100 mg;                                         CTD              Ready   IOR        IOR
 Tamsulosin HCl                                Capsule                                    0.4mg                                              CTD              Ready   IOR        IOR
 Terbinafine                                   Tablet                                     125, 250mg                                         CTD              Ready   IOR        IOR
 Topiramate                                    Tablet                                     25,50,100,200mg                                    CTD              Ready   IOR        IOR
 Torsemide                                     Tablet                                     5,10mg                                             CTD              Ready   IOR        IOR
 Tramadol HCl                                  Capsule                                    50 mg                                              CTD              Ready   IOR        IOR
 Tramadol HCl + Acetaminophen                  Tablet                                     37.5+325 mg                                        CTD              Ready   IOR        IOR
 Trandolapril                                  Capsule                                    0.5,1,2, 4mg                                       CTD              Ready   IOR        IOR
 Ursodiol                                      Tablet                                     150, 250, 300, 400, 450, 500mg |                   CTD              Ready   IOR        IOR
 Ursodiol                                      Capsule                                    150, 200, 250, 300mg                               CTD              Ready   IOR        IOR
 Valacyclovir                                  Tablet                                     500,1000 mg;                                       CTD              Ready   IOR        IOR
 Venlafaxine HCl                               Tablet                                     25,37.5,50,75mg                                    CTD              Ready   IOR        IOR
 Venlafaxine HCl                               Capsule - XR                               37.5, 75, 150mg                                    CTD              Ready   IOR        IOR
 Zidovudine                                    Capsule                                     100, 250mg                                        CTD              Ready   IOR        IOR
 Zolpidem Tartrate                             Tablet                                     5,10mg                                             CTD              Ready   IOR        IOR




   13        IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
FEATURED DEVELOPERS                                                                                                                               Global Generic
                                                                                                                                                                                              Product directory




                                                                           Bluepharma is a privately owned pharmaceutical company, based in Portugal. The main activities of the company include
                                            COMPANY NAME                   development, manufacturing and marketing of generic products for human use.
                                              Bluepharma                   Bluepharma has human resources and dedicated facilities allocated to R&D activities, covering formulation, development and
                                                                           validation of analytical methods, scale-up, manufacturing of pilot batches, stability studies and regulatory affairs. Our company
                                                                           is approved for the manufacturing and packaging of human investigational medicinal products. Starting in 2010 Bluepharma has
                                                  CITY                     the capacities to develop oncology products. The manufacturing site of the company exhibits a modern layout and is equipped
                                                 Coimbra                   with state of the art equipment for the manufacturing of solid dosage forms.
                                                                           We account for a significant track record of successful developments, as well as for innumerous partnerships with top players in
                                                                           the pharmaceutical industry worldwide, including USA.
                                               COUNTRY
                                                                           Core Sales Territory: Global Regulated Markets
                                                Portugal                   Core Operation: Sales and Marketing, Finished Dose Manufacture, Distribution
                                                                           Contact Person: Mr. André Garnel Freitas; Head of Business Development
                                                                                                                                  DOSSIER          DOSSIER APPROVED                 REGULATORY
MOLECULE NAME                    DOSE FORM                           DOSE STRENGTH                                                FORMAT           STATUS COUNTRY                   STATUS
Acarbose                           Tablet                             25 mg, 50 mg, 100 mg                                          CTD              Ready           Portugal        PLG
Aripiprazole                       Tablet                             5 mg, 10 mg, 15 mg, 20 mg, 30 mg                              CTD              Ready           N/A             NRP
Atorvastatin                       Tablet - Film coated               10 mg, 20 mg, 40 mg, 80 mg                                    CTD              Ready           Portugal        IOR
Azithromycin                       Tablet - Film coated               500 mg                                                        CTD              Ready           Portugal        PLG
Candesartan                        Tablet                             2 mg, 4 mg, 8 mg, 16 mg, 32 mg                                CTD              Ready           Portugal        PLG
Candesartan + HCTZ                 Tablet                             8 mg + 12.5 mg, 16 mg + 12.5 mg                               CTD              Ready           Portugal        PLG
Clarithromycin                     Tablet - Film coated               250 mg, 500 mg                                                CTD              Ready           Portugal        PLG
Clopidogrel Besylate               Tablet                             75 mg                                                         CTD              Ready           N/A             IOR
Ibandronate / Ibandronic Acid      Tablet - Film coated               50 mg, 150 mg                                                 CTD              Ready           N/A             IOR
Irbesartan                         Tablet - Film coated               75 mg, 150 mg, 300 mg                                         CTD              Ready           N/A             DCP underway
                                                                      150 mg + 12.5 mg, 300 mg + 12.5 mg, 300 mg
Irbesartan + HCTZ                  Tablet - Film coated                                                          CTD                                 Ready           N/A             DCP underway
                                                                      + 25 mg
Levetiracetam                      Solution - Oral                    100 mg/ml                                                     CTD              Ready           Portugal        PLG
Levetiracetam                      Tablet - Film coated               250 mg, 500 mg, 750 mg, 1000 mg                               CTD              Ready           Portugal        PLG
Losartan                           Tablet - Film coated               12.5 mg, 25 mg, 50 mg, 100 mg                                 CTD              Ready           Portugal        PLG
Losartan + HCTZ                    Tablet - Film coated               50 mg + 12.5 mg, 100 mg + 25 mg                               CTD              Ready           Portugal        PLG
Nicorandil                         Tablet                             10 mg, 20 mg                                                  CTD              Ready           Portugal        PLG
Nimesulide                         Tablet                             100 mg                                                        CTD              Ready           Portugal        PLG
Pramipexole                        Tablet - Film coated               125 µg, 250 µg, 500 µg, 1000 µg, 1500 µg                      CTD              Ready           Portugal        NRP
Propiverine                        Tablet - Film coated               5 mg, 15 mg                                                   CTD              Ready           Portugal        PLG

                                Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.                         14
Global Generic
Product directory
                            FEATURED DEVELOPERS
                                                                                       The Chanelle Group was established in 1983 as a distributor of animal health products and is now the largest veterinary pharma-
                                                          COMPANY NAME                 ceutical manufacturer and distributor in Ireland. It diversified in 1980 into the development and manufacture of veterinary generic
                                                             Chanelle                  pharmaceutical products and is also a major player in the pet care market. A further diversification in 1995 with Chanelle Medical
                                                                                       been established as a developer & manufacturer of medical generic products.
                                                                                       Chanelle Medical are a one-stop-shop where we offer; formulation development, method development & validation, pilot batches,
                                                                 CITY                  stability studies, monitoring of BE studies, compilation of dossier, registration of dossier, sale of dossier, manufacture and packing
                                                               Loughrea                finish product. This company has approximately 900 generic product licenses (both Vet & Med) granted to date in 80 countries. The
                                                                                       Group is privately owned, has a turnover of €60m, 220 employees with it’s head office in Loughrea, Co. Galway and offices in UK,
                                                                                       France & Jordan.
                                                             COUNTRY                   Core Sales Territory: Western Europe
                                                              Ireland                  Core Operation: Sales and Marketing, Finished Dose Manufacture
                                                                                       Contact Person: Mrs. Chanelle McCoy; Director of Medical Business
                                                                                                                                                DOSSIER         DOSSIER APPROVED REGULATORY
 Molecule name                          DOSE FORM                            DOSE STRENGTH                                                      FORMAT          STATUS COUNTRY STATUS
 Alkamed (Gaviscon)                     Solution - Oral                      0.5%                                                               CTD             Ready          Ireland           PLG
 Amlodipine                             Capsule                              5 mg, 10 mg                                                        CTD             Ready          Ireland           PLG
 Amorolfine                             Nail Lacquer                         5%                                                                 CTD             Ready          Ireland           DCP underway
 Atenolol                               Solution - Oral                      25 mg / 5 ml                                                       CTD             Ready          Ireland           PLG
 Bisacodyl                              Tablet                               5 mg                                                               CTD             Ready          Ireland           PLG
 Bisoprolol                             Tablet                               1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, 10 mg                      CTD             Ready          Ireland           PLG
 Cefaclor                               Capsule                              250 mg, 500 mg                                                     CTD             Ready          Ireland           PLG
 Cetirizine                             Solution - Oral                      1 mg/ml                                                            CTD             Ready          Ireland           PLG
 Cetirizine                             Tablet                               10 mg                                                              CTD             Ready          Ireland           PLG
 Citalopram                             Tablet                               10 mg, 20 mg, 40 mg                                                CTD             Ready          Ireland           PLG
 Clindamycin                            Capsule                              75 mg, 150 mg, 300 mg                                              CTD             Ready          Ireland           PLG
 Doxycycline                            Capsule                              50 mg, 100 mg                                                      CTD             Ready          Ireland           PLG
                                                                                                                                                                                                 DCP slot booked (Dec
 Escitalopram                           Solution - Oral                      20 mg/ml                                                           CTD             Ready          N/A
                                                                                                                                                                                                 2011)
 Exemestane                             Tablet                               25 mg                                                              CTD             Ready          Ireland           DCP underway
 Fexofenadine                           Tablet                               120 mg, 180 mg                                                     CTD             Ready          Ireland           PLG
                                                                                                                                                                                                 DCP slot booked (Dec
 Frovatriptan                           Tablet                               2.5 mg                                                             CTD             In-Dev         N/A
                                                                                                                                                                                                 2011)
 Glibenclamide                          Tablet                               1.25 mg, 2.5 mg, 5 mg                                              CTD             Ready          Ireland           PLG
 Glucosamine Sulphate                   Tablet - Film coated                 500 mg (3x daily), 750 mg (2x daily), 1000 mg (1x daily) CTD                       Ready          Ireland           PLG

   15         IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
CHANELLE MEDICAL
                                                 FEATURED DEVELOPERS                                                                                                                              Global Generic
                                                                                                                                                                                                  Product directory




                                                                                                                                            DOSSIER          DOSSIER APPROVED REGULATORY
Molecule name               DOSE FORM                                DOSE STRENGTH                                                          FORMAT           STATUS COUNTRY STATUS
Lacidipine                  Tablet                                   4 mg, 6 mg                                                             CTD              In-Dev          N/A         NRP
Macrogol (Movicol)          Sachet                                   6.86g, 13.72g                                                          CTD              Ready           N/A         DCP underway
Meloxicam                   Tablet                                   7.5 mg, 15 mg                                                          CTD              Ready           Ireland     PLG
Memantine                   Solution - Oral                          10 mg/ml                                                               CTD              In-Dev          N/A         DCP slot booked
Metronidazole               Tablet                                   200 mg, 400 mg                                                         CTD              Ready           Ireland     PLG
Mirtazapine                 Tablet - Dispersible (ODT)               15 mg, 30 mg, 45 mg                                                    CTD              Ready           Ireland     PLG
Naratriptan                 Tablet                                   2.5 mg                                                                 CTD              Ready           N/A         DCP underway
Olanzapine                  Tablet                                   2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg                              CTD              Ready           Ireland     PLG
Paroxetine Hemihydrate      Tablet                                   20 mg, 30 mg                                                           CTD              Ready           Ireland     PLG
                                                                                                                                                                                         DCP slot booked
Riluzole                    Tablet                                   50 mg                                                                  CTD              In-Dev          N/A
                                                                                                                                                                                         (Febr 2012)
Risperidone                 Solution - Oral                          1 mg/ml                                                                CTD              Ready           Ireland     PLG
Roxithromycin               Tablet                                   150 mg                                                                 CTD              Ready           Ireland     PLG
Sodium Bicarbonate          Capsule                                  500 mg                                                                 CTD              Ready           Ireland     PLG
Sumatriptan Succinate       Tablet                                   50 mg, 100 mg                                                          CTD              Ready           Ireland     PLG
Zonisamide                  Capsule                                  25 mg, 50 mg, 100 mg                                                   CTD              In-Dev          N/A         NRP




                                     Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.                      16
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
Genericlicensing.com - featured companies 2011
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Genericlicensing.com - featured companies 2011

  • 1. Global Generic Product Directory FeatureD ComPanies Edition 3, 2011
  • 2. This is the 3rd ever edition of the Global Generic Product Directory We're really proud of this one. We've listened carefully to our community and made some changes. In this edition we have focused on presenting our recommended developers. Too much choice can be paralyzing; so you will now a FEATURED DEVELOPERS section at the front. We have also replaced 25% of the developers for one's we consider better partners for your business. Remember that you can find the contact details for all the listed developers online and its costs you nothing to make an enquiry. : Find a product Go online to Make contact with you like in the www.genericlicensing.com the developer directory Genericlicensing Limited has been set up to help you do more business, more effectively. We understand the industry is changing. We understand that you want to find new value-added products for new markets. During 2011 we will introduce new data for: Biosimilars, Super Generics & Over-the-Counter We want to be the first place you turn to when you think about a new product In order to better support you and your business, we are working hard to introduce more services online. You can now ask us to post WANTED products online so the developers can come to you! Enjoy the 3rd edition, we hope you will love, cherish and share it (ie tell other people about it!) The world of generics at your fingertips! Asa Cox Founder, Genericlicensing Limited asa.cox@genericlicensing.com skype: asa_cox Legal: All the information contained in the directory has been provided by manufacturers and developers in good faith; Genericlicensing Limited cannot therefore guarantee the accuracy of the data. Any consequential loss cannot be accepted as a result of any business conducted with companies listed or their products.
  • 3. Contents FEATURED DEVELOPERS listed alphabetically Antiobiotic ........................ 1 Astron ........................ 2 – 8 Aurobindo ........................ 9 – 13 BluePharma ........................ 14 Chanelle Medical ........................ 15 – 16 FamyCare Ltd. ........................ 17 Farmaprojects ........................ 18 – 20 Hikma ........................ 21 – 39 LogenexPharm ........................ 40 Lupin ........................ 41 – 44 Naari ........................ 45 Neogen ........................ 46 Orion ........................ 47 Rivopharm ........................ 48 Technimede ........................ 49 – 52 Wockhardt ........................ 53 – 59 Worwag ........................ 60 Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.
  • 4. Research: groups of patents. Development: Approximately 50 products registered; about 20 further in development. Capacity: 3 manufacturing facilities – cutting-edge, computer-controlled manufacturing technology – including electronic batch recording. Quality: and transfer and inventory coverage. Responsiveness: Global supply chain management services. Marketing/ Distribution: Major generic player in UK and Israel; fully We geared up to win tenders in Germany. Presence in several more markets target our goals. worldwide via distribution partners. target our drugs. Interested in: Contract manufacturing Contract development/Co-development time our delivery… Out-licencing In-licencing Distribution EU-re-analyses/ release For more information please visit www.dexcel.com because timing is everything Contact: oren.weininger@dexcel.com, mohitsingh@dexcelpharma.co.uk
  • 6. FEATURED DEVELOPERS Global Generic Product directory Antibiotic - Razgrad JSC, as the successor of the largest producer of antibiotics in Bulgaria. Balkanpharma-Razgrad JSC, has over 50 COMPANY NAME years experience in the development, production and sales of generic medicines for human and veterinary use. Antibiotic - Razgrad Antibiotic JSC is the majority owner of Balkanpharma-Razgrad JSC - a pharmaceutical plant with production units for finished dosage forms: capsules and tablets, semi-solid dosage forms, sterile liquid and dry injectable forms and also an industrial unit for lyophilized APIs. The portfolio of products covers various therapeutic areas with an accent on infectious diseases, ophthalmology and dermatology. CITY Antibiotic - Razgrad JSC has the necessary manufacture licenses and EU GMP certification for all productions and currently exports Razgad to more than 25 countries in Europe and Asia. The development strategy of the company includes the implementation of modern technologies and new products elaborated by its own R&D activities and is oriented towards expanding sales in international markets. Apart from own market presence, the company is open to out-licensing and contract manufacturing projects. COUNTRY Core Sales Territory: Eastern Europe Bulgaria Core Operation: API Manufacture, Finished Dose Manufacture, Sales and Marketing Contact Person: Ms Gergana Semova; Managing Director DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Betamethasone + Gentamicin Cream 1 mg + 1 mg CTD Ready Bulgaria PLG Betamethasone + Gentamicin Ointment 1 mg + 1 mg CTD Ready Bulgaria PLG Betamethasone Valerate Cream 1 mg / g CTD Ready Bulgaria PLG Betamethasone Valerate Ointment 1 mg / g CTD Ready Bulgaria PLG Dexamethasone Tablet 0.5 mg CTD Ready Bulgaria PLG Fluconazole Injection - Solution 2 mg/ml - 50 ml, 100 ml CTD Ready Bulgaria PLG Fluconazole Capsule 150 mg eCTD In-Dev Bulgaria Fluconazole Capsule 200 mg eCTD In-Dev Bulgaria Gentamicin Ointment - Eye 3 mg / g CTD Ready Bulgaria PLG Hydrocortison + Chloramphenicol Ointment - Eye 5 mg/g + 2 mg/g CTD Ready Bulgaria PLG Levofloxacin Injection - Solution 5 mg/ml - 50 ml CTD Ready Bulgaria PLG Levofloxacin Injection - Solution 5 mg/ml - 100 ml CTD Ready Bulgaria PLG Levofloxacin Drops - Eye 5 mg/ml - 5 ml CTD Ready Bulgaria PLG Methylprednisolone Tablet 4 mg CTD Ready Bulgaria PLG Methylprednisolone Tablet 4 mg CTD Ready Bulgaria PLG Prednisolone Tablet 5 mg CTD Ready Bulgaria PLG Prednisone Tablet 5 mg CTD Ready Bulgaria PLG Tobramycin Ointment - Eye 3 mg/g CTD Ready Bulgaria PLG Tobramycin + Dexamethasone Ointment - Eye 3 mg/g + 1 mg/g CTD Ready Bulgaria PLG Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 1
  • 7. Global Generic Product directory FEATURED DEVELOPERS Astron Research Ltd was established in the year 2001 with an objective to provide prompt and reliable services to Pharma sector COMPANY NAME worldwide and improve the product quality with the help of Technological Innovations and Upgradations. Astron commenced its Astron Research Ltd UK operations in 2004 for Quality Testing and QP Release of finished formulations and API. This facility is now UK-MHRA approved. Astron Research Ltd has products and technology are sold in over 50 countries, which includes European Union, US, Canada Austra- lia, New Zealand, South Africa, Brazil, Mexico, Middle East & North African countries. 18 ANDAs filed in US and 38 EU CTD dossiers CITY developed till 2007. Astron Research Ltd is capable of handling Formulation and Analytical Research of Solid Orals, Injectables, Ahmedabad Lyophilised injectables, Topicals, Effervescent tablets, Specialty medicaments like Potent drugs & Oncology products. The company has also acquired expertise in oral NDDS and Controlled Release pellets. COUNTRY Core Sales Territory: Global Regulated Markets Core Operation: API Manufacture, Finished Dose Manufacture, Sales and Marketing, Distribution India Contact Person: Marc Comas, VP Business Development DOSSIER DOSSIER APPROVED REGULATORY Molecule name DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Aceclofenac Tablet - Film coated 100 mg CTD Ready Spain PLG Alendronate / Alendronic Acid Tablet 5 mg, 10 mg, 70 mg CTD Ready IOR PLG Anastrozole Tablet - Film coated 1 mg ANDA Ready IOR NRP Anastrozole Tablet - Film coated 1 mg CTD Ready IOR PLG Aripiprazole Tablet - Dispersible (ODT) 5 mg, 10 mg, 15 mg, 30 mg CTD In-Dev N/A DCP slot booked Aripiprazole Tablet - Dispersible (ODT) 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg ANDA In-Dev N/A NRP Atorvastatin Tablet 10 mg, 20 mg, 40 mg, 80 mg CTD In-Dev N/A NRP Atorvastatin Tablet 10 mg, 20 mg, 40 mg, 80 mg ANDA In-Dev N/A NRP Bicalutamide Tablet - Film coated 50 mg CTD Ready IOR PLG Bicalutamide Tablet - Film coated 50 mg ANDA Ready IOR PLG Bisoprolol Tablet 2.5 mg, 5 mg, 10 mg CTD In-Dev N/A DCP slot booked Calcium Carbonate Tablet - Effervescent 500 mg CTD Ready IOR DCP underway Candesartan Tablet 2 mg, 4 mg, 8 mg, 16 mg, 32 mg CTD In-Dev N/A NRP Capecitabine Tablet - Film coated 150 mg, 500 mg CTD In-Dev N/A DCP slot booked Carbidopa + Levodopa Tablet - SR 50 mg + 200 mg, 25 mg + 100 mg CTD In-Dev N/A NRP Carbidopa + Levodopa Tablet - SR 50 mg + 200 mg, 25 mg + 100 mg ANDA In-Dev N/A NRP Carboplatin Injection 10 mg / ml (5 ml, 15 ml, 45 ml vials) ANDA In-Dev N/A NRP Carboplatin Injection 10 mg/ml (60 ml) CTD Ready IOR NRP Carboplatin Injection 10 mg / ml (5 ml, 15 ml, 45 ml vials) CTD Ready IOR PLG Cisplatin Injection - Solution 1 mg/ml (100 ml) CTD Ready IOR NRP 2 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • 8. ASTRON RESEARCH LTD FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORY Molecule name DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Cisplatin Injection - Solution 1 mg/ml (10 ml, 25 ml, 50 ml) CTD Ready IOR PLG Clopidogrel Tablet 75 mg ANDA In-Dev N/A NRP Clopidogrel Hydrogenbisulphat Tablet 75 mg CTD Ready IOR DCP underway Clozapine Capsule - XR 25 mg, 50 mg, 100 mg, 200 mg CTD In-Dev N/A NRP Cytarabine Injection 100 mg/ml (1 ml, 5 ml, 10 ml) CTD Ready IOR PLG Darifenacin Tablet - SR 7.5 mg, 15 mg CTD In-Dev N/A NRP Docetaxel Injection 40 mg/ml (0.5 ml, 2 ml) CTD Ready IOR DCP underway Docetaxel Injection 40 mg/ml (0.2 ml, 0.8 ml) ANDA Ready IOR NRP Donepezil Tablet 5 mg, 10 mg CTD Ready IOR PLG Donepezil Tablet 5 mg, 10 mg ANDA Ready IOR NRP Doxorubicin Injection - Solution 2 mg/ml (5 ml, 25 ml, 100 ml) CTD Ready UK PLG 150 mg, 300 mg (3 ml), 0.2 ml, 0.4 ml, 0.6 ml, 0.8 ml, Enoxaparin Injection - Pre-filled syringe CTD In-Dev N/A NRP 1 ml 150 mg, 300 mg (3 ml), 0.2 ml, 0.4 ml, 0.6 ml, 0.8 ml, Enoxaparin Injection - Pre-filled syringe ANDA In-Dev N/A NRP 1 ml Epirubicin Injection - Solution 2 mg/ml (5 ml, 10 ml, 25 ml, 100 ml) ANDA In-Dev N/A NRP Epirubicin Injection - Solution 2 mg/ml (5 ml, 10 ml, 25 ml, 100 ml) CTD Ready IOR PLG Escitalopram Tablet 10 mg, 20 mg, 40 mg CTD Ready IOR PLG Etoposide Injection 20 mg/ml (12.5 ml, 25 ml) ANDA Ready IOR NRP Exemestane Tablet 25 mg CTD Ready IOR PLG Exemestane Tablet 25 mg ANDA In-Dev N/A NRP Fesoterodine Tablet - SR 4 mg, 8 mg CTD In-Dev N/A NRP Finasteride Tablet 1 mg CTD Ready IOR PLG Finasteride Tablet 5 mg CTD Ready IOR PLG Finasteride Tablet 1 mg ANDA Ready IOR NRP Finasteride Tablet 5 mg ANDA Ready IOR PLG Fludarabine Injection 50 mg/ml (2ml) ANDA Ready IOR NRP Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 3
  • 9. Global Generic Product directory FEATURED DEVELOPERS ASTRON RESEARCH LTD DOSSIER DOSSIER APPROVED REGULATORY Molecule name DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Fluorouracil (5FU) Injection 50 mg/ml (5 ml, 10 ml, 20 ml, 100 ml) ANDA In-Dev N/A NRP Fluorouracil (5FU) Injection 50 mg/ml (5 ml, 10 ml, 20 ml, 100 ml) CTD Ready IOR PLG Fluvastatin Tablet - SR 80 mg CTD In-Dev N/A DCP slot booked Fluvastatin Tablet - SR 80 mg ANDA In-Dev N/A NRP Gabapentin Tablet - Film coated 600 mg, 800 mg CTD Ready Finland PLG Gemcitabine Injection - Ready-to-use 0.2 g, 1 g, 1.5 g, 2 g CTD In-Dev N/A DCP underway Gemcitabine Injection - Powder 2000 mg CTD Ready IOR DCP slot booked Gemcitabine Injection - Powder 200 mg, 1000 mg CTD Ready IOR PLG Gemcitabine Injection - Powder 200 mg, 1000 mg, 2000 mg ANDA Ready IOR NRP Glimepiride Tablet 1 mg, 2 mg, 3 mg, 4 mg CTD Ready IOR PLG Glimepiride Tablet 1 mg, 2 mg, 4 mg ANDA Ready IOR PLG Imatinib Tablet 100 mg, 400 mg CTD In-Dev N/A DCP slot booked Irbesartan Tablet 75 mg, 150 mg, 300 mg CTD Ready IOR PLG Irinotecan Injection 20 mg/ml (2 ml, 5 ml) CTD Ready IOR PLG Irinotecan Injection 20 mg/ml (2 ml, 5 ml) ANDA In-Dev N/A NRP Irinotecan Injection 20 mg/ml (25 ml) CTD Ready IOR NRP Iron Sucrose Injection 20 mg/ml (5 ml vial) ANDA In-Dev N/A NRP Lansoprazole Tablet - Enteric coated 15 mg, 30 mg CTD In-Dev N/A DCP slot booked Lansoprazole Capsule - SR 15 mg, 30 mg ANDA In-Dev N/A NRP Letrozole Tablet - Film coated 2.5 mg CTD Ready IOR PLG Letrozole Tablet - Film coated 2.5 mg ANDA Ready IOR PLG Levetiracetam Tablet 250 mg, 500 mg, 750 mg, 1000 mg CTD Ready IOR DCP slot booked Levetiracetam Tablet 250 mg, 500 mg, 750 mg, 1000 mg ANDA Ready N/A Approved Levodopa + Carbidopa Tablet 100 mg + 25 mg, 200 mg + 50 mg CTD Ready N/A DCP underway Levodopa + Carbidopa Tablet 100 mg + 25 mg, 200 mg + 50 mg ANDA In-Dev N/A NRP Levofloxacin Tablet 250 mg, 500 mg CTD Ready N/A DCP underway Levothyroxine Tablet 25/50/75/88/100/112/125/137/150/175/200/300 µg CTD In-Dev N/A NRP 4 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • 10. ASTRON RESEARCH LTD FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORY Molecule name DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Levothyroxine Tablet 25/50/75/88/100/112/125/137/150/175/200/300 µg ANDA In-Dev N/A NRP Losartan Potassium Tablet - Film coated 25 mg, 50 mg, 100 mg CTD Ready IOR PLG Meloxicam Injection 5 mg/ml (10 ml) ANDA Ready IOR NRP Methotrexate Injection 5 mg/ml (3 ml) CTD Ready Sweden PLG Methotrexate Injection 25 mg/ml (2ml) CTD Ready IOR NRP Methotrexate Injection 100 mg/ml (5 ml, 10 ml) CTD Ready IOR NRP Methotrexate Injection 5 mg/ml (3 ml) ANDA In-Dev N/A NRP Methotrexate Injection 25 mg/ml (2ml) ANDA In-Dev N/A NRP Methotrexate Injection 100 mg/ml (5 ml, 10 ml) ANDA In-Dev N/A NRP Methotrexate Injection 25 mg/ml (20 ml. 40 ml) CTD Ready IOR NRP Metoprolol Succinate Tablet - SR 25 mg, 50 mg, 100 mg, 200 mg ANDA Ready IOR NRP Midazolam Injection 1 mg/ml (5 ml) CTD Ready IOR PLG Midazolam Injection 5 mg/ml (1 ml, 3 ml, 10 ml) CTD Ready IOR PLG Mitomycin Injection - Powder 5 mg, 20 mg, 40 mg ANDA Ready IOR PLG Mitomycin Injection - Powder 0.2 mg/vial ANDA In-Dev N/A NRP Mitoxantrone Injection 2 mg/ml (10 ml, 12.5 ml, 15 ml) ANDA In-Dev N/A NRP Montelukast Tablet - Chewable 4 mg, 5 mg CTD Ready Europe PLG Montelukast Tablet - Film coated 10 mg CTD In-Dev N/A DCP underway Montelukast Tablet - Film coated 10 mg ANDA In-Dev N/A NRP Mycophenelate Mofetil Injection - Powder 500 mg CTD In-Dev N/A DCP underway Mycophenelate Mofetil Capsule - Hard gel 250 mg ANDA Ready IOR PLG Mycophenelate Mofetil Capsule - Hard gel 250 mg CTD Ready IOR PLG Mycophenelate Mofetil Tablet - Film coated 500 mg CTD Ready IOR PLG Mycophenelate Mofetil Tablet - Film coated 500 mg ANDA Ready IOR PLG Naltrexone Tablet 50 mg CTD Ready UK PLG Naltrexone Tablet 50 mg ANDA Ready IOR NRP Olanzapine Tablet 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg CTD Ready IOR DCP underway Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 5
  • 11. Global Generic Product directory FEATURED DEVELOPERS ASTRON RESEARCH LTD DOSSIER DOSSIER APPROVED REGULATORY Molecule name DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Olanzapine Tablet 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg ANDA In-Dev N/A NRP Olmasertan Tablet 5 mg, 10 mg, 20 mg, 40 mg CTD In-Dev N/A DCP slot booked Omeprazole Capsule 20 mg, 40 mg CTD In-Dev N/A DCP slot booked Ondansetron Injection 2 mg/ml (2 ml, 4 ml) CTD Ready IOR PLG Ondansetron Injection 2 mg/ml (2 ml, 4 ml) ANDA In-Dev N/A NRP Orlistat Capsule 60 mg CTD In-Dev N/A NRP Oxaliplatin Injection - Powder 50 mg, 100 mg CTD Ready IOR PLG Oxaliplatin Injection - Ready-to-use 50 mg, 100 mg CTD Ready IOR PLG Oxaliplatin Injection - Ready-to-use 5 mg/ml (10 ml, 20 ml, 40 ml) ANDA In-Dev N/A NRP Oxaliplatin Injection - Ready-to-use 200 mg CTD Ready IOR NRP Oxcarbazepine Capsule - XR 300 mg, 600 mg CTD In-Dev N/A NRP Oxybutynin Tablet - SR 5 mg, 10 mg, 15 mg CTD In-Dev N/A NRP Paclitaxel Injection - Solution 6 mg/ml (5 ml, 16.7 ml, 50 ml) CTD Ready IOR DCP underway Paclitaxel Injection - Solution 6 mg/ml (5 ml, 16.7 ml, 50 ml) ANDA Ready IOR NRP Paliperidone Tablet - SR 1.5 mg, 3 mg, 6 mg, 9 mg ANDA In-Dev N/A NRP Pantoprazole Sodium Tablet - Enteric coated 20 mg, 40 mg CTD In-Dev N/A DCP slot booked Pantoprazole Sodium Tablet - SR 20 mg, 40 mg ANDA In-Dev N/A NRP Paracetamol Tablet - Effervescent 500 mg, 1000 mg CTD Ready IOR PLG Pemetrexed Injection - Powder 100 mg, 500 mg CTD In-Dev N/A DCP slot booked Pioglitazone Tablet 15 mg, 30 mg, 45 mg CTD Ready IOR DCP slot booked Pioglitazone Tablet 15 mg, 30 mg, 45 mg ANDA Ready IOR NRP Pramipexole Tablet 125 µg, 250 µg, 500 µg, 1000 µg, 1500 µg CTD In-Dev N/A NRP Pramipexole Tablet 125 µg, 250 µg, 500 µg, 1000 µg, 1500 µg ANDA In-Dev N/A NRP Pravastatin Tablet 10 mg, 20 mg, 40 mg CTD Ready IOR PLG Pravastatin Tablet 10 mg, 20 mg, 40 mg, 80 mg ANDA In-Dev N/A NRP 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 Pregabalin Capsule CTD In-Dev N/A NRP mg, 300 mg 6 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • 12. ASTRON RESEARCH LTD FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORY Molecule name DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Quetiapine Tablet - SR 200 mg, 300 mg, 400 mg CTD Ready IOR DCP underway Quetiapine Tablet - IR 25 mg, 100 mg, 150 mg, 200 mg, 300 mg CTD Ready IOR DCP underway Quetiapine Tablet - SR 50 mg CTD In-Dev N/A DCP slot booked Quetiapine Tablet - IR 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg ANDA In-Dev N/A NRP Quetiapine Tablet - SR 150 mg, 200 mg, 300 mg, 400 mg ANDA Ready IOR NRP Quetiapine Tablet - SR 50 mg ANDA In-Dev N/A NRP Quinine Sulphate Tablet 300 mg CTD Ready IOR NRP Rabeprazole Tablet 10 mg, 20 mg CTD In-Dev N/A DCP slot booked Ramipril Tablet 1.25 mg, 2.5 mg, 5 mg, 10 mg CTD In-Dev N/A DCP underway Ranitidine Tablet - Effervescent 150 mg, 300 mg CTD Ready IOR PLG Ranitidine Tablet - Effervescent 75 mg CTD In-Dev N/A NRP Rasagiline Tablet 1 mg CTD In-Dev N/A NRP Repaglinide Tablet 0.5 mg, 1 mg, 2 mg CTD In-Dev N/A DCP slot booked Risperidone Tablet - Film coated 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, 6 mg CTD Ready IOR PLG Ropinirole Tablet - Film coated 0.25 mg, 0.5 mg, 1 mg, 2 mg, 5 mg CTD Ready IOR PLG Sildenafil Tablet 25 mg, 50 mg, 100 mg CTD Ready IOR DCP underway Simvastatin Tablet - Film coated 10 mg, 20 mg, 40 mg, 80 mg ANDA Ready IOR PLG Sirolimus Tablet 1 mg, 2 mg CTD In-Dev N/A DCP slot booked Sodium Valproate Tablet - SR 300 mg, 500 mg CTD In-Dev N/A NRP Solifenacin succinate Tablet - Film coated 5 mg, 10 mg CTD In-Dev N/A DCP slot booked Sumatriptan Succinate Tablet 50 mg, 100 mg CTD Ready Finland PLG Tacrolimus Capsule - Hard gel 0.5 mg, 1 mg, 5 mg CTD Ready IOR DCP underway Tacrolimus Capsule - Hard gel 0.5 mg, 1 mg, 5 mg ANDA Ready IOR NRP Tacrolimus Ointment 0.01%, 0.03% CTD In-Dev N/A NRP Tadalafil Tablet 2.5 mg, 5 mg, 10 mg, 20 mg CTD In-Dev N/A DCP slot booked Telmisartan Tablet 20 mg, 40 mg, 80 mg CTD In-Dev N/A DCP slot booked Telmisartan + HCTZ Tablet 40 mg + 12.5 mg, 80 mg + 12.5 mg CTD In-Dev N/A NRP Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 7
  • 13. Global Generic Product directory FEATURED DEVELOPERS ASTRON RESEARCH LTD DOSSIER DOSSIER APPROVED REGULATORY Molecule name DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Temozolomide Capsule - Hard gel 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg CTD Ready IOR NRP Temozolomide Capsule - Hard gel 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg ANDA Ready IOR NRP Terazosin Tablet 1 mg, 2 mg, 5 mg, 10 mg CTD Ready IOR PLG Tolterodine Capsule - XR 2 mg, 4 mg CTD In-Dev N/A DCP slot booked Tolterodine Capsule - SR 4 mg ANDA In-Dev N/A NRP Tolterodine Tablet - IR 1 mg, 2 mg CTD Ready IOR PLG Topiramate Tablet 25 mg, 50 mg, 100 mg, 200 mg CTD Ready IOR PLG Topotecan Injection - Powder 4 mg CTD Ready IOR PLG Topotecan Injection - Ready-to-use 4 mg CTD In-Dev N/A NRP Vardenafil Tablet - Film coated 5 mg, 10 mg, 20 mg CTD In-Dev N/A NRP Vitamin C Tablet - Effervescent 500 mg CTD In-Dev N/A NRP Voriconazole Tablet 50/200 mg CTD In-Dev N/A NRP 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg, Warfarin Tablet CTD In-Dev N/A DCP slot booked 10 mg 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg, Warfarin Tablet ANDA Ready IOR NRP 10 mg Ziprasidone Capsule 20 mg, 40 mg, 60 mg, 80 mg CTD In-Dev N/A NRP 8 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • 14. Global Generic Product directory FEATURED DEVELOPERS Aurobindo Pharma was born of a vision. The company is the market leader in semi-synthetic penicillin drugs. It has a presence in COMPANY NAME key therapeutic segments like SSPs, cephalosporins, antivirals, CNS, cardiovascular, gastroenterology, etc. Over the years, the Au- Aurobindo robindo Pharma has evolved into a knowledge driven company. It is R&D focused, has a multi-product portfolio with multi-country manufacturing facilities, and is becoming a marketing conglomerate across the world. Aurobindo Pharma created a name for itself in the manufacture of bulk actives, its area of core competence. The formulation busi- CITY ness is systematically organized with a divisional structure, and has a focused team for each key international market. Aurobindo Hyderabad believes in gaining volume and market share in every business/segment it enters. Core Sales Territory: Global Regulated Markets COUNTRY Core Operation: API Manufacture, Finished Dose Manufacture, Sales and Marketing, Distribution India Contact Person: Mr Vivek Shah; Business Support Manager DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Alendronate sodium Tablet 10, 70 mg; CTD Ready IOR IOR Alendronate sodium + Cholecalciferol Tablet 70mg+2800IU, 70mg+5600IU CTD Ready IOR IOR Alfuzosin HCl Tablet - XR 10 mg CTD Ready IOR IOR Alfuzosin HCl Tablet 2.5mg CTD Ready IOR IOR Alprazolam Tablet 0.25,0.5,1mg CTD Ready IOR IOR Amisulpride Tablet 50, 100, 200, 400mg CTD Ready IOR IOR Amlodipine Tablet 5&10 mg; CTD Ready IOR IOR Amlodipine Capsule 5,10mg CTD Ready IOR IOR Amoxicillin Capsule 250,500mg CTD Ready IOR IOR Amoxicillin Tablet 1G CTD Ready IOR IOR Amoxicillin + Clavulanic Acid PFOS 125+31.25, 250+62.5 mg: Sugar free CTD Ready IOR IOR Azithromycin Suspension - Oral 200mg/5ml, 500mg/5ml* CTD Ready IOR IOR Azithromycin Tablet 250/500/600mg CTD Ready IOR IOR Benazepril Tablet 5, 10, 20mg CTD Ready IOR IOR Betahistine Tablet 8,16,24mg CTD Ready IOR IOR Bisoprolol Fumarate Tablet 1.25,2.5,3.75,5mg CTD Ready IOR IOR Carvedilol Tablet 3.125,6.25,12.5,25mg CTD Ready IOR IOR Cefixime Suspension - Oral 100mg/5ml CTD Ready IOR IOR Cefixime Tablet 200,400mg CTD Ready IOR IOR 9 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • 15. AUROBINDO PHARMA FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Cefpodoxime Proxetil Suspension - Oral 40mg/5ml CTD Ready IOR IOR Cefpodoxime Proxetil Tablet 100, 200mg CTD Ready IOR IOR Cefprozil PFOS 125, 250mg/5ml CTD Ready IOR IOR Cefprozil Tablet 250, 500mg CTD Ready IOR IOR Cefuroxime Axetil Tablet 250,500mg; UK, PL 125 mg CTD Ready IOR IOR Cephalexin Capsule 250,500mg CTD Ready IOR IOR Cetirizine HCl Tablet 10 mg CTD Ready IOR IOR Ciprofloxacin HCl Tablet 250,500,750mg CTD Ready IOR IOR Citalopram HBr Tablet 10,20,40 mg CTD Ready IOR IOR Clarithromycin Tablet 250,500mg CTD Ready IOR IOR Clindamycin HCl Capsule 150, 300 mg CTD Ready IOR IOR Cloxacillin Capsule 250, 500mg CTD Ready IOR IOR Didanosine Capsule - EC 200250400 CTD Ready IOR IOR Doxazosin Mesylate Tablet 1,2,4,8mg CTD Ready IOR IOR Enalapril Maleate Tablet 5, 10, 20mg CTD Ready IOR IOR Esomeprazole Magnesium Tablet - DR 20,40mg CTD Ready IOR IOR Finasteride Tablet 5mg CTD Ready IOR IOR Finasteride Tablet 1mg CTD Ready IOR IOR Fluconazole Suspension - Oral 50, 200 mg / 5ml, CTD Ready IOR IOR Fluconazole Capsule 50,100,150,200mg CTD Ready IOR IOR Fluoxetine HCl Solution - Oral 20mg/5ml CTD Ready IOR IOR Fluoxetine HCl Capsule 10, 20, 40, 60mg CTD Ready IOR IOR Fosinopril + HCTZ Tablet 20+12.5mg CTD Ready IOR IOR Fosinopril Sodium Tablet 10, 20 mg CTD Ready IOR IOR Furosemide Tablet 20, 40mg CTD Ready IOR IOR Gabapentin Capsule 100,300,400mg CTD Ready IOR IOR Gabapentin Tablet 600,800mg; CTD Ready IOR IOR Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 10
  • 16. Global Generic Product directory FEATURED DEVELOPERS AUROBINDO PHARMA DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Glimepiride Tablet 1,2,3,4mg CTD Ready IOR IOR Lamotrigine Tablet 25, 50, 100, 200 mg CTD Ready IOR IOR Lamotrigine Tablet - Chewable 2, 5, 25, 50, 100, 200mg CTD Ready IOR IOR Lansoprazole Capsule - DR 15,30mg CTD Ready IOR IOR Lansoprazole Tablet - Dispersible (ODT) 15, 30 mg CTD Ready IOR IOR Levetiracetam Solution - Oral 100mg/ml CTD Ready IOR IOR Levetiracetam Tablet 250,500,750mg, 1g CTD Ready IOR IOR Lisinopril Tablet 5, 10, 20, 30, 40 mg CTD Ready IOR IOR Lisinopril + HCTZ Tablet 10+12.5,20+12.5mg CTD Ready IOR IOR Losartan Potassium Tablet 12.5, 25, 50, 100mg CTD Ready IOR IOR Losartan Potassium + HCTZ Tablet 50+12.5, 100+25mg CTD Ready IOR IOR Meloxicam Tablet 7.5,15mg CTD Ready IOR IOR Metformin HCl Tablet 500,850,1000mg CTD Ready IOR IOR Metoprolol Tartrate Tablet 50,100 & 200MG CTD Ready IOR IOR Mirtazapine Tablet - Dispersible (ODT) : 15, 30, 45mg CTD Ready IOR IOR Mirtazapine Plain Tablet 15,30,45mg CTD Ready IOR IOR Modafinil Tablet 100 mg CTD Ready IOR IOR Moxifloxacin HCl Tablet 400mg CTD Ready IOR IOR Naproxen Tablet 250, 500mg CTD Ready IOR IOR Naproxen Sodium Tablet 550mg CTD Ready IOR IOR Nevirapine TFOS 50 mg PEPFAR PED CTD Ready IOR IOR Nevirapine Tablet 200mg CTD Ready IOR IOR Nitrofurantoin Capsule 100mg (75mg MH + 25 Mcryst) CTD Ready IOR IOR Olanzapine Tablet 2.5, 5, 7.5, 10, 15, 20 mg CTD Ready IOR IOR Olanzapine Tablet - Dispersible (ODT) 5,10,15,20 mg CTD Ready IOR IOR Omeprazole Pellet - DR 10,20,40mg CTD Ready IOR IOR Ondansetron Tablet - Dispersible (ODT) 4,8mg CTD Ready IOR IOR 11 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • 17. AUROBINDO PHARMA FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Ondansetron HCl Tablet 4,8 mg CTD Ready IOR IOR Pantoprazole sodium Tablet - DR 20,40mg CTD Ready IOR IOR Paroxetine HCl Tablet 20,30mg CTD Ready IOR IOR Pen V potassium Tablet 250, 800, 1000mg, 1.0 m.u, 1.5m.u CTD Ready IOR IOR Perindopril Erbumine Tablet 2,4,8mg CTD Ready IOR IOR Phenytoin Sodium Tablet EU: 50,100mg CTD Ready IOR IOR Pioglitazone Tablet 15,30,45mg CTD Ready IOR IOR Pramipexole Tablet 0.125, 0.25, 0.5, 1, 1.5 mg CTD Ready IOR IOR Pravastatin Tablet 10, 20, 40mg CTD Ready IOR IOR Quinapril HCl Tablet 5,10,20,40mg CTD Ready IOR IOR Quinapril HCl + HTZ Tablet 10+12.5, 20+12.5, 20+25 mg CTD Ready IOR IOR Ramipril Capsule 1.25,2.5,5,10mg: CTD Ready IOR IOR Ramipril Tablet 1.25, 2.5, 5,10mg; CTD Ready IOR IOR Ranitidine HCl Syrup 15mg/1ml CTD Ready IOR IOR Repaglinide Tablet 0.5, 1, 2 mg CTD Ready IOR IOR Ribavirin Capsule 200mg CTD Ready IOR IOR Ribavirin Tablet 200, 400mg CTD Ready IOR IOR Risedronate Tablet 5, 30, 35mg CTD Ready IOR IOR Risedronate Sodium+Calcium Tablet 35+500mg; CTD Ready IOR IOR carbonate Risperidone Tablet 0.5,1,2,3,4,6mg, CTD Ready IOR IOR Risperidone Solution - Oral 1mg/ml CTD Ready IOR IOR Rizatriptan Tablet 5, 10mg CTD Ready IOR IOR Rizatriptan Tablet - Dispersible (ODT) 5, 10mg CTD Ready IOR IOR Ropinirole Tablet 0.25,0.5,1,2,5 mg CTD Ready IOR IOR Rosuvastatin Ca Tablet 5, 10, 20, 40mg CTD Ready IOR IOR Sertraline HCl Tablet 50,100mg CTD Ready IOR IOR Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 12
  • 18. Global Generic Product directory FEATURED DEVELOPERS DOSSIER AUROBINDO PHARMA DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Sertraline HCl Tablet 50,100mg CTD Ready IOR IOR Sertraline HCl Capsule 25,50,100mg CTD Ready IOR IOR Simvastatin Tablet 5,10,20,30,40,60,80mg; CTD Ready IOR IOR Sotalol Tablet 40, 80, 160mg CTD Ready IOR IOR Sumatriptan Succinate Tablet 50,100 mg; CTD Ready IOR IOR Tamsulosin HCl Capsule 0.4mg CTD Ready IOR IOR Terbinafine Tablet 125, 250mg CTD Ready IOR IOR Topiramate Tablet 25,50,100,200mg CTD Ready IOR IOR Torsemide Tablet 5,10mg CTD Ready IOR IOR Tramadol HCl Capsule 50 mg CTD Ready IOR IOR Tramadol HCl + Acetaminophen Tablet 37.5+325 mg CTD Ready IOR IOR Trandolapril Capsule 0.5,1,2, 4mg CTD Ready IOR IOR Ursodiol Tablet 150, 250, 300, 400, 450, 500mg | CTD Ready IOR IOR Ursodiol Capsule 150, 200, 250, 300mg CTD Ready IOR IOR Valacyclovir Tablet 500,1000 mg; CTD Ready IOR IOR Venlafaxine HCl Tablet 25,37.5,50,75mg CTD Ready IOR IOR Venlafaxine HCl Capsule - XR 37.5, 75, 150mg CTD Ready IOR IOR Zidovudine Capsule 100, 250mg CTD Ready IOR IOR Zolpidem Tartrate Tablet 5,10mg CTD Ready IOR IOR 13 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • 19. FEATURED DEVELOPERS Global Generic Product directory Bluepharma is a privately owned pharmaceutical company, based in Portugal. The main activities of the company include COMPANY NAME development, manufacturing and marketing of generic products for human use. Bluepharma Bluepharma has human resources and dedicated facilities allocated to R&D activities, covering formulation, development and validation of analytical methods, scale-up, manufacturing of pilot batches, stability studies and regulatory affairs. Our company is approved for the manufacturing and packaging of human investigational medicinal products. Starting in 2010 Bluepharma has CITY the capacities to develop oncology products. The manufacturing site of the company exhibits a modern layout and is equipped Coimbra with state of the art equipment for the manufacturing of solid dosage forms. We account for a significant track record of successful developments, as well as for innumerous partnerships with top players in the pharmaceutical industry worldwide, including USA. COUNTRY Core Sales Territory: Global Regulated Markets Portugal Core Operation: Sales and Marketing, Finished Dose Manufacture, Distribution Contact Person: Mr. André Garnel Freitas; Head of Business Development DOSSIER DOSSIER APPROVED REGULATORY MOLECULE NAME DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Acarbose Tablet 25 mg, 50 mg, 100 mg CTD Ready Portugal PLG Aripiprazole Tablet 5 mg, 10 mg, 15 mg, 20 mg, 30 mg CTD Ready N/A NRP Atorvastatin Tablet - Film coated 10 mg, 20 mg, 40 mg, 80 mg CTD Ready Portugal IOR Azithromycin Tablet - Film coated 500 mg CTD Ready Portugal PLG Candesartan Tablet 2 mg, 4 mg, 8 mg, 16 mg, 32 mg CTD Ready Portugal PLG Candesartan + HCTZ Tablet 8 mg + 12.5 mg, 16 mg + 12.5 mg CTD Ready Portugal PLG Clarithromycin Tablet - Film coated 250 mg, 500 mg CTD Ready Portugal PLG Clopidogrel Besylate Tablet 75 mg CTD Ready N/A IOR Ibandronate / Ibandronic Acid Tablet - Film coated 50 mg, 150 mg CTD Ready N/A IOR Irbesartan Tablet - Film coated 75 mg, 150 mg, 300 mg CTD Ready N/A DCP underway 150 mg + 12.5 mg, 300 mg + 12.5 mg, 300 mg Irbesartan + HCTZ Tablet - Film coated CTD Ready N/A DCP underway + 25 mg Levetiracetam Solution - Oral 100 mg/ml CTD Ready Portugal PLG Levetiracetam Tablet - Film coated 250 mg, 500 mg, 750 mg, 1000 mg CTD Ready Portugal PLG Losartan Tablet - Film coated 12.5 mg, 25 mg, 50 mg, 100 mg CTD Ready Portugal PLG Losartan + HCTZ Tablet - Film coated 50 mg + 12.5 mg, 100 mg + 25 mg CTD Ready Portugal PLG Nicorandil Tablet 10 mg, 20 mg CTD Ready Portugal PLG Nimesulide Tablet 100 mg CTD Ready Portugal PLG Pramipexole Tablet - Film coated 125 µg, 250 µg, 500 µg, 1000 µg, 1500 µg CTD Ready Portugal NRP Propiverine Tablet - Film coated 5 mg, 15 mg CTD Ready Portugal PLG Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 14
  • 20. Global Generic Product directory FEATURED DEVELOPERS The Chanelle Group was established in 1983 as a distributor of animal health products and is now the largest veterinary pharma- COMPANY NAME ceutical manufacturer and distributor in Ireland. It diversified in 1980 into the development and manufacture of veterinary generic Chanelle pharmaceutical products and is also a major player in the pet care market. A further diversification in 1995 with Chanelle Medical been established as a developer & manufacturer of medical generic products. Chanelle Medical are a one-stop-shop where we offer; formulation development, method development & validation, pilot batches, CITY stability studies, monitoring of BE studies, compilation of dossier, registration of dossier, sale of dossier, manufacture and packing Loughrea finish product. This company has approximately 900 generic product licenses (both Vet & Med) granted to date in 80 countries. The Group is privately owned, has a turnover of €60m, 220 employees with it’s head office in Loughrea, Co. Galway and offices in UK, France & Jordan. COUNTRY Core Sales Territory: Western Europe Ireland Core Operation: Sales and Marketing, Finished Dose Manufacture Contact Person: Mrs. Chanelle McCoy; Director of Medical Business DOSSIER DOSSIER APPROVED REGULATORY Molecule name DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Alkamed (Gaviscon) Solution - Oral 0.5% CTD Ready Ireland PLG Amlodipine Capsule 5 mg, 10 mg CTD Ready Ireland PLG Amorolfine Nail Lacquer 5% CTD Ready Ireland DCP underway Atenolol Solution - Oral 25 mg / 5 ml CTD Ready Ireland PLG Bisacodyl Tablet 5 mg CTD Ready Ireland PLG Bisoprolol Tablet 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, 10 mg CTD Ready Ireland PLG Cefaclor Capsule 250 mg, 500 mg CTD Ready Ireland PLG Cetirizine Solution - Oral 1 mg/ml CTD Ready Ireland PLG Cetirizine Tablet 10 mg CTD Ready Ireland PLG Citalopram Tablet 10 mg, 20 mg, 40 mg CTD Ready Ireland PLG Clindamycin Capsule 75 mg, 150 mg, 300 mg CTD Ready Ireland PLG Doxycycline Capsule 50 mg, 100 mg CTD Ready Ireland PLG DCP slot booked (Dec Escitalopram Solution - Oral 20 mg/ml CTD Ready N/A 2011) Exemestane Tablet 25 mg CTD Ready Ireland DCP underway Fexofenadine Tablet 120 mg, 180 mg CTD Ready Ireland PLG DCP slot booked (Dec Frovatriptan Tablet 2.5 mg CTD In-Dev N/A 2011) Glibenclamide Tablet 1.25 mg, 2.5 mg, 5 mg CTD Ready Ireland PLG Glucosamine Sulphate Tablet - Film coated 500 mg (3x daily), 750 mg (2x daily), 1000 mg (1x daily) CTD Ready Ireland PLG 15 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • 21. CHANELLE MEDICAL FEATURED DEVELOPERS Global Generic Product directory DOSSIER DOSSIER APPROVED REGULATORY Molecule name DOSE FORM DOSE STRENGTH FORMAT STATUS COUNTRY STATUS Lacidipine Tablet 4 mg, 6 mg CTD In-Dev N/A NRP Macrogol (Movicol) Sachet 6.86g, 13.72g CTD Ready N/A DCP underway Meloxicam Tablet 7.5 mg, 15 mg CTD Ready Ireland PLG Memantine Solution - Oral 10 mg/ml CTD In-Dev N/A DCP slot booked Metronidazole Tablet 200 mg, 400 mg CTD Ready Ireland PLG Mirtazapine Tablet - Dispersible (ODT) 15 mg, 30 mg, 45 mg CTD Ready Ireland PLG Naratriptan Tablet 2.5 mg CTD Ready N/A DCP underway Olanzapine Tablet 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg CTD Ready Ireland PLG Paroxetine Hemihydrate Tablet 20 mg, 30 mg CTD Ready Ireland PLG DCP slot booked Riluzole Tablet 50 mg CTD In-Dev N/A (Febr 2012) Risperidone Solution - Oral 1 mg/ml CTD Ready Ireland PLG Roxithromycin Tablet 150 mg CTD Ready Ireland PLG Sodium Bicarbonate Capsule 500 mg CTD Ready Ireland PLG Sumatriptan Succinate Tablet 50 mg, 100 mg CTD Ready Ireland PLG Zonisamide Capsule 25 mg, 50 mg, 100 mg CTD In-Dev N/A NRP Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission. 16