Glenmark gets USFDA nod for generic version of AstraZeneca diabetes drug Onglyza

Published On 2023-08-02 09:00 GMT   |   Update On 2023-08-02 09:00 GMT

Mumbai: Glenmark Pharmaceuticals Ltd., a research‐led, integrated, global pharmaceutical company has received final approval from the United States Food & Drug Administration (U.S. FDA) for Saxagliptin Tablets, 2.5 mg and 5 mg. The product is a generic version of diabetes drug Onglyza, 2.5 mg and 5 mg, of AstraZeneca AB.

Glenmark’s Saxagliptin Tablets, 2.5 mg and 5 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

According to IQVIA sales data for the 12‐month period ending June 2023, the Onglyza Tablets, 2.5 mg and 5 mg market achieved annual sales of approximately $100.7 million*.

Glenmark’s current portfolio consists of 184 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.

Read also: Washing powder maker Nirma and Sekhmet vie for USD 731 million Glenmark Life stake: Sources

Glenmark Pharmaceuticals Ltd. is an integrated, research‐led, global pharmaceutical company, with a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 10 world‐class manufacturing facilities spread across 4 continents, and operations in over 80 countries. 




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