Granules India receives USFDA approval for generic Methylergonovine tablets

17 May 2018 Evaluate

Granules India has received an approval from the United States Food & Drug Administration (USFDA) for 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. 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 India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).

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