Instant Report

Date: 12-Nov-2020

Glenmark Pharma Receives US FDA Approval For Generic Prograf Capsules

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (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 market achieved annual sales of approximately US$ 286.8 million.

Glenmark's current portfolio consists of 166 products authorized for distribution in the US market place and 45 ANDA's pending approval with the US FDA. 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.