New Delhi: The US Food and Drug Administration (USFDA) has approved Granules India’s abbreviated new drug application (ANDA) for Methylergonovine 0.2 mg tablets.
Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India Ltd, had filed the abbreviated new drug application. The approved ANDA is the bioequivalent to the reference listed drug product Methergine 0.2 mg.
Methylergonovine is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum haemorrhage.
Granules Pharmaceuticals Inc., Granules India’s R&D and manufacturing subsidiary in Virginia, was established with an objective to foray into the development and manufacture of products that are niche, on several levels.
“Our first product approval from this site is a “first generic”, to the market and is a testimony to our objectives and execution capabilities,” Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India Ltd, said in a release.