Sunday, 21 July 2019

Glenmark receives ANDA approval for generic version of Nexium®

14 May 2019 | News

Glenmark’s current portfolio consists of 153 products authorized for distribution in the U.S. marketplace

Glenmark Pharmaceuticals 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® 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.

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