Glenmark receives ANDA approval for Esomeprazole Magnesium Delayed‐Release Capsules USP

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Biznextindia : Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Esomeprazole Magnesium Delayed‐Release Capsules USP, 20 mg and 40 mg, a generic version of Nexium®1 Delayed‐Release Capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP.

According to IQVIATM sales data for the 12 month period ending March 2019, the Nexium® Delayed‐Release Capsules, 20 mg and 40 mg market2 achieved annual sales of approximately $395.1 million.   Glenmark’s current portfolio consists of 153 products authorized for distribution in the U.S. marketplace and 58 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.

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