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Granules India has received USFDA’s approval for Methylergonovine 0.2 mg tablets.
The abbreviated new drug applications (ANDA) was filed by Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India. The approved ANDA is the bioequivalent to the reference listed drug product, Methergine 0.2 MG.
The approved tablet is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum haemorrhage. Further, Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India stated, “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.”
