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Glenmark Generics today said it has received U.S. health regulator’s nod to market generic version of AstraZeneca’s Prilosec, a drug used for treatment of ulcer, in the U.S. market.
Glenmark Generics Inc (GGI) has been granted the final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (USFDA) for Omeprazole Delayed Release Capsules, their generic version of Prilosec by AstraZeneca, a company statement said.
The approval is for the 10, 20, and 40 mg strengths of Omeprazole.
Quoting IMS Health sales data for the 12 month period ending September 2014, Glenmark said Omeprazole garnered annual sales of approximately $520 million.
Glenmark’s current portfolio consists of 94 products authorised for distribution in the U.S. market and 72 ANDAs are pending approval with the USFDA.
“In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio,” the company said.
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