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Glenmark receives US FDA approval to market generic Gabapentin |
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25 Aug 2006 |
Glenmark Pharmaceuticals, Inc., USA [GPI], the wholly owned US subsidiary of Glenmark Pharmaceuticals Limited [Glenmark], received US FDA approval to market Gabapentin oral tablets 600 mg and 800 mg.
MUMBAI, India | Aug 24, 2006 | Glenmark Pharmaceuticals, Inc., USA [GPI], the wholly owned US subsidiary of Glenmark Pharmaceuticals Limited [Glenmark], received US FDA approval to market Gabapentin oral tablets 600 mg and 800 mg. Gabapentin belongs to a category of anti-convulsants and is prescribed to help control epileptic seizures. It is also widely used to relieve different kinds of pain and even psychiatric disorders. The drug enjoys a generic market size of USD 328 million.
Glenmark manufactures the drug at its solid-oral formulation facility at Goa and will commence shipments of Gabapentin immediately. Gabapentin is the fourth ANDA filed by Glenmark from the Goa facility to receive US FDA approval after Fluconazole, Zonisamide and Meloxicam. With this approval, Glenmark will have ten generics on the market including two controlled substances: Codeine Phosphate launched in June and Morphine Sulphate which is in the process of being launched.
About Glenmark
Glenmark Pharmaceuticals Ltd. is a research-led, global, fully integrated pharmaceutical company headquartered in Mumbai, India. The Company has generic formulation and API business interests in over 80 countries across the world including the highly regulated markets of USA and Europe. The formulation business spans several product segments such as Dermatology, Internal Medicine, Paediatrics, Gynaecology, ENT and Diabetes.
The Company in also engaged in cutting-edge research in discovering new molecules and runs discovery projects in the areas of inflammation [Asthma/COPD, etc] and metabolic disorders [Diabetes, Obesity, etc]. Its first Asthma/COPD molecule, Oglemilast [GRC 3886], was licensed out to Forest Laboratories and Teijin Pharma Limited for the North American and Japanese markets, respectively. This compound has recently entered Phase II clinical trials in the US. The Company’s second lead GRC 8200, a DPP-IV inhibitor for Type II Diabetes, is in Phase II clinical trials in South Africa. Glenmark’s third lead is a compound named GRC 10389, a CB-I receptor antagonist for the treatment of Obesity. This compound is completing pre-clinical studies and is expected to be filed for a Phase I trial in H1 FY07. The Company has three other programmes across inflammation and pain management scheduled to enter the clinics in FY 2007. [www.glenmarkpharma.com]
For further information, please contact:
Ms. Vaijayanti Karande
Senior Manager [Corporate Communications]
Glenmark Pharmaceuticals Limited
Tel: [+91 22] 6758 9913 | Fax: [+91 22] 6758 9986
Email:
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SOURCE: Glenmark Pharmaceuticals, Inc |
