This document summarizes Astron Research Ltd, a featured developer in the Global Generic Product Directory. Astron is an Indian pharmaceutical company established in 2001 that develops and manufactures generic pharmaceutical products. It has dossiers for over 100 molecules ready or in development for global markets. Astron has capabilities across the pharmaceutical value chain including API manufacturing, finished dose production, marketing and distribution. It is seeking partnerships for product development and commercialization.
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)
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)
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)