The US Food and Drug Administration (USFDA) has granted final approval
for the company's abbreviated new drug application (ANDA) for
Metformin Hydrochloride extended-release tablets USP, 500 mg and 1000
mg, Granules said in a regulatory filing.
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/granules-gets-american-drug-regulators-nod-for-diabetes-management-drug-metformin/articleshow/80246744.cms
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