Glenmark gets USFDA nod to market generic Meloxicam
Our Bureau / Mumbai July 20, 2006
Glenmark Pharmaceuticals Limited [Glenmark] received US FDA approval to market Meloxicam oral tablets 7.5 mg and 15 mg, a generic version of Boehringer Ingelheim’s brand Mobic. The drug belongs to a category of Non-steroidal Anti-Inflammatory Drugs [NSAID] and is prescribed for the indication of Osteoarthritis with annual sales of about USD 936 million. The generic will be marketed by Glenmark’s US subsidiary, Glenmark Pharmaceutical Inc., which will commence supplying the generic drug to customers in the US immediately.
Glenmark is manufacturing the drug at its solid-oral formulation facility at Goa; this is the third ANDA filed by Glenmark from the Goa facility that has received US FDA approval after Fluconazole and Zonisamide. Glenmark currently markets 7 products in the US with the last launched product being Codeine Phosphate, a controlled substance.
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 subsequently completed Phase I clinical trials successfully and 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 at the pre-clinical stages. [www.glenmarkpharma.com]
Glenmark gets USFDA nod to market generic Meloxicam
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