Glenmark receives final USFDA approval for Tacrolimus Capsules

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 Prograf1 Capsules, 0.5 mg, 1 mg and 5 mg, of Astellas Pharm US, Inc.

According to IQVIATM 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 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.

Powered by Capital Market - Live News