has announced that its US (Virginia) based subsidiary Granules Pharmaceuticals Inc, has received final USFDA approval for its Abbreviated New Drug Applications (ANDA) for Methylergonovine 0.2 mg Tablets.
The approved ANDA is 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.
The ANDA approval is in line with company expectation to foray in niche products. This is also a first product approval for US site.
Granules will be competing with Lupin
in Methylergonovine 0.2 mg Tablet market.