Granules’ approved product is the bioequivalent to the reference listed drug product Methergine 0.2 mg. Photo: Pradeep Gaur/Mint
New Delhi: Drug firm Granules India on Thursday said its subsidiary has received approval from the US health regulator for Methylergonovine tablets, used for the prevention and control of postpartum haemorrhage.
In a filing to BSE, Granules India said “the US Food and Drug Administration (USFDA) has approved its abbreviated new drug applications (ANDA) for Methylergonovine 0.2 mg tablets. The ANDA was filed by Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India Ltd”.
The approved product is the bioequivalent to the reference listed drug product Methergine 0.2 mg, it added.
Shares of Granules India were trading at Rs105.40 per scrip on BSE, up by 8.94%.
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