Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. 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 $286.8 million*.

Glenmark’s current portfolio consists of 166 products authorized for distribution in the U.S. marketplace and 45 ANDA’s pending approval with the U.S. 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.

Glenmark Pharmaceuticals Ltd. (GPL) is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries. Glenmark’s key therapy focus areas globally are respiratory, dermatology and oncology. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenue.