Glenmark gets FDA nod for rosuvastatin calcium tablets

NEW DELHI: Glenmark Pharmaceuticals has received final approval from the US health regulator USFDA for rosuvastatin calcium tablets, used in lowering cholesterol.

"Glenmark Pharmaceuticals Inc, USA has been granted final approval by the US Food and Drug Administration (US FDA) for rosuvastatin calcium tablets," it said in a BSE filing.

Crestor is used to lower cholesterol and fats (triglycerides) in the blood and is used to reduce the chances of developing problems such as heart disease and strokes.

Rosuvastatin calcium tablets are generic version of Crestor tablets of IPR Pharmaceuticals, Inc. Approval has been granted in the strengths of 5 mg, 10 mg, 20 mg and 40 mg.

Quoting IMS sales data for the 12 months to May 2016, Glenmark said Rosuvastatin calcium tablets achieved annual sales of around USD 6.78 billion.

The company's current portfolio consists of 115 products authorised for distribution in the US market and 61 ANDA pending approval with the USFDA.

Shares of Glenmark Pharmaceuticals were trading 2.11 per cent up, at Rs 850.75 in the morning trade on BSE.