Glenmark receives US FDA approval for cardiac and NSAIDs generics

Glenmark Pharmaceuticals Ltd has announced that the Company received US FDA approval to market Pravastatin Sodium oral tablets 10mg, 20mg and 40mg, a generic version of Bristol Myers Squibb brand Pravachol that has annual sales of over $861 million.

Pravachol is one of the most extensively studied drugs of its kind, used for reducing the risk of first and second heart attack

Glenmark currently manufactures the finished dose formulation at its US FDA approved manufacturing facility in Goa, India. Its 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, the company also received US FDA approval to market the non-steroidal anti-inflammatory drug naproxen sodium oral tablets EQ 250mg and 500mg base, a generic version of Roche''s brand Anaprox and Naproxen oral tables 250mg, 375mg and 500mg, a generic version of Hoffmann-La Roche AG brand Naprosyn.

The drugs have annual sales of $13 million and $53 million respectively. Naproxen is a These drugs are also manufactured at the Company''s Goa facility and will be marketed in the US by GPI.

With these approvals, the Glnmark''s subsidiary GPI will have 15 generic products in the US market. It already has over 35 ANDAs undergoing US FDA approval process / launch.