Glenmark Pharmaceuticals Ltd, a research-based company has received US FDA approval to market Pravastatin sodium oral tablets 10 mg, 20 mg and 40 mg, a generic version of Bristol Myers Squibb brand Pravachol that has annual sales of over USD 861 million.

Glenmark is manufacturing the finished dose formulation at its US FDA approved manufacturing facility in Goa, India. Glenmark's US subsidiary, Glenmark Pharmaceuticals Inc., USA [GPI] is responsible for marketing the product in the US and will commence supplies of the drug to customers immediately.

In the preceding month, Glenmark also received US FDA approval to market Naproxen Sodium oral tablets EQ 250 mg and 500 mg base, a generic version of Roche's brand Anaprox and Naproxen oral tablets 250 mg, 375 mg and 500 mg, a generic version of Hoffmann-La Roche AG brand Naprosyn. The drugs have annual sales of USD 13 million and USD 53 million respectively. These drugs are also manufactured at Glenmark's Goa facility and will be marketed in the US by GPI.

With these approvals, Glenmark's subsidiary GPI will have 15 generic products in the US market. The company has over 35 ANDAs undergoing US FDA approval process.

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 recently out-licensed to Merck KGaA, Germany for the North American, European and Japanese markets. A third molecule targeting pain, GRC 6211, is undergoing phase I clinical trials in Europe. Glenmark has three other programmes across obesity, in inflammation and pain management at the pre-clinical stages; all of which should enter the clinics in by H1 FY 2008.