Glenmark Pharmaceuticals gets final nod for Apremilast Tablets

17 Oct 2023 Evaluate

Glenmark Pharmaceuticals (Glenmark Pharma) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Apremilast Tablets, 10 mg, 20 mg and 30 mg, the generic version of Otezla Tablets, 10 mg, 20 mg and 30 mg, of Amgen Inc.

According to IQVIATM sales data for the 12-month period ending August 2023, the Otezla Tablets, 10 mg, 20 mg, and 30 mg market achieved annual sales of approximately $3.7 billion. Glenmark’s current portfolio consists of 188 products authorized for distribution in the U.S. marketplace and 50 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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