Glenmark Pharma gets ANDA approval for Tacrolimus Capsules

Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (US FDA) for Tacrolimus Capsules USP, 0.5 mg, 1 mg and 5 mg, the generic version of Prograf Capsules, 0.5 mg, 1 mg and 5 mg, of Astellas Pharm US, Inc.

According to IQVIA, sales data for the 12 month period ending September 2020, the Prograf Capsules, 0.5 mg, 1 mg and 5 mg market2 achieved annual sales of approximately $286.8 million.

Glenmark’s current portfolio consists of 166 products authorised for distribution in the US marketplace and 45 ANDA’s pending approval with the US FDA.