Drug firm Granules India today 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 U S 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.
Also read: Drug maker Granules’ ANDA gets USFDA nod