Glenmark receives US FDA approval

Mumbai, May 16: Pharma major Glenmark Pharmaceuticals Ltd, an emerging research based global pharma company, today announced that it had received US Food and Drugs Administration (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 US 861 million dollars.

The company is manufacturing the finished dose formulation at its USFDA approved manufacturing facility in Goa, India. The company'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, Glenmark said in a communication to the Bombay Stock Exchange (BSE) today.

In the preceding month, the company 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 the company's Goa facility and will be marketed in the US by GPI.

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

UNI