Glenmark receives ANDA approval for Rosuvastatin Calcium tablets

20 July 2016 | News | By BioSpectrum Bureau

Glenmark Pharmaceuticals USA (Glenmark), has been granted final approval by the United States Food & Drug Administration (USFDA) for Rosuvastatin Calcium Tablets, 5 mg (base), 10 mg (base), 20 mg (base), and 40 mg (base), the generic version of Crestor Tablets, 5 mg, 10 mg, 20 mg, and 40 mg of IPR Pharmaceuticals (IPR).

According to IMS Health sales data for the 12 month period ending May 2016, the Rosuvastatin Calcium Tablets, 5 mg (base), 10 mg (base), 20 mg (base), and 40 mg (base) market achieved annual sales of approximately $6.78 billion.

Glenmark's current portfolio consists of 115 products authorized for distribution in the US marketplace and 61 ANDA's pending approval with the USFDA.

In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.