Mumbai, Jan 23 (UNI) Pharma Major, Glenmark Pharma Said that its US subsidiary Glenmark Pharmaceuticals Inc., USA has been granted tentative approval by the United States Food & Drug Administration (USFDA) for Abiraterone Acetate Tablets USP, 250 mg, a generic version of Zytiga Tablets, 250 mg, of Janssen Biotech, Inc.
According to IQVIATM sales data for the 12 month period ending November 2018, the Zytiga Tablets, 250 mg market achieved annual sales of approximately USD1.3 billion.
Glenmark’s current portfolio consists of 148 products authorised for distribution in the US marketplace and 54 ANDA’s pending approval with the USFDA. 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.
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