The US Food & Drug Administration (FDA) has granted final approval for Glenmark Pharmaceuticals' rosuvastatin calcium tablets, 5 mg (base), 10 mg (base), 20 mg (base) and 40 mg (base), the generic version of IPR Pharmaceuticals Inc's Crestor tablet.
According to IMS Health sales data for 12 month period ending May 2016, the rosuvastatin calcium tablets market achieved annual sales of approximately $ 6.78 billion.
Glenmark's current portfolio consists of 115 products authorised for distribution in the US marketplace and 61 ANDAs pending approval with the US FDA.
