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Glenmark receives tentative US FDA approval for its ANDA for Terbinafine HCL tablets |
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22 Jun 2007 |
Glenmark Pharmaceuticals Ltd. received tentative approval from the US FDA for its Abbreviated New Drug Application for Terbinafine HCL 250 mg oral tablets
MUMBAI, India | June 21, 2007 | Glenmark Pharmaceuticals Ltd. [Glenmark], a researchbased pharmaceutical company headquartered in Mumbai (India) received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Terbinafine HCL 250 mg oral tablets. It is the AB-rated generic equivalent of Novartis's anti-fungal Lamisil® tablets with annual sales of over USD 650 million (IMS-Dec 2006) in the US. Glenmark is manufacturing the finished dose formulation at its USFDA approved manufacturing facility in Goa, India. Glenmark’s US subsidiary, Glenmark Pharmaceuticals Inc., USA [GPI] will start marketing the product in the US upon patent expiry (June 30, 2007).
With this approval, GPI now has a portfolio of 16 generic products for the US market and has over 35 ANDAs undergoing US FDA approval process/launch.
About Glenmark Pharmaceuticals Inc., USA [GPI]
Glenmark’s US subsidiary, Glenmark Pharmaceuticals Inc., USA [GPI], was established in 2003 to enter into the world's largest pharmaceutical market. GPI is responsible for sales and marketing of generic drug formulations in the USA as well as APIs to customers in the regulated markets. GPI closed last Fiscal year with sales of USD 50 Mn from its formulations business.
About Glenmark
Glenmark Pharmaceuticals Ltd. is a research-led, global, fully integrated pharmaceutical company headquartered in Mumbai, India. The Company is a leader in India in the discovery of new molecules and is focused in the areas of inflammation [Asthma/COPD, etc] and metabolic disorders [Diabetes, Obesity, etc]. 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, Diabetes and Oncology. Glenmark’s 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, in two landmark deals. Oglemilast is presently undergoing Phase II clinical trials in the US. The Company’s second lead GRC 8200, a DPP-IV inhibitor for Type II Diabetes was out-licensed to Merck KGaA, Germany for the North American, European and Japanese markets. A third molecule targeting pain, GRC 6211, is undergoing Phase II clinical trials in Europe. Glenmark has three other programmes across obesity, inflammation and pain management at the pre-clinical stages; all of which should enter the clinics in by H1 FY 2008.
SOURCE: Glenmark Pharmaceuticals Ltd. |
