Granules India receives USFDA approval for Methylergonovine tablet

This is the first approval for Granules from its US site. Granules will be competing with Lupin in Methylergonovine tablet.

May 17, 2018 03:05 IST India Infoline News Service

Granules India
Granules India 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. 

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