Granules India Ltd. has announced that the U.S. FDA 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 Limited. The approved ANDA is the bioequivalent to the reference listed drug product (RLD), Methergine 0.2 mg. Methylergonovine is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum haemorrhage.

"Granules Pharmaceuticals Inc., our 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," said Mr. Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India Limited.