Glenmark Pharmaceuticals gets approvals from USFDA for generic Prograf capsules

Portfolio includes 166 products authorised for distribution in United States


GlenmarkGlenmark Pharmaceuticals Inc., USA has received final approval by the United States Food & Drug Administration (USFDA) for Tacrolimus Capsules USP, 0.5 mg, 1 mg and 5 mg.

These are the generic version of Prograf®1 Capsules, 0.5 mg, 1 mg and 5 mg, of Astellas Pharm US, Inc.

As per the 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 around US$ 286.8 million.

Current scenario

At present, Glenmark’s portfolio includes 166 products authorised for distribution in the United States marketplace and 45 ANDA’s pending approval with the USFDA.

Besides these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

A global research-led pharmaceutical company, Glenmark Pharmaceuticals Ltd. (GPL) has presence across Generics, Specialty and OTC business with operations in over 50 countries.

The company’s key therapy focus areas internationally are dermatology, respiratory and oncology. It is ranked among the top 80 Pharma and Biotech companies of the world in terms of revenue, as per SCRIP 100 Rankings published in 2019.

(With inputs from The OnLook News Research Bureau)

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