Glenmark Pharma’s arm gets USFDA’s final approval for Abiraterone Acetate Tablets

20 May 2022 Evaluate

Glenmark Pharmaceuticals’ subsidiary -- Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the United States Food & Drug Administration (USFDA) for Abiraterone Acetate Tablets USP, 500 mg, the generic version of Zytiga Tablets, 500 mg, of Janssen Biotech Inc.

According to IQVIA sales data for the 12 month period ending March 2022, the Zytiga Tablets, 500 mg market achieved annual sales of approximately $260.2 million.
Glenmark’s current portfolio consists of 173 products authorized for distribution in the U.S. marketplace and 49 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 is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.

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