Granules India drug gets approval from USFDA
Granules India Ltd. said it had got U.S. Food and Drug Administration (USFDA) approval for its abbreviated new drug application (ANDA) for Methylergonovine 0.2 mg tablets. The approved ANDA, filed by Granules Pharmaceuticals Inc., a subsidiary, is the bio equivalent to the reference listed drug product (RLD) Methergine 0.2 mg. Methylergonovine is a semi-synthetic ergot alkaloid used for prevention and control of postpartum haemorrhage, Granules said in a statement on Thursday.
Granules India chairman and managing director Krishna Prasad Chigurupati said Granules Pharmaceuticals Inc, the 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. The first product approval from this facility is a “first generic,” to the market and testimony to the company’s objectives and execution capabilities, he added.
Jeedimetla plant gets EIR
In a separate development, Granules India said its Jeedimetla facility in Hyderabad had received Establishment Inspection Report (EIR) from the USFDA. The regulator had in March inspected by facility and issued one 483 observation during the inspection. The company had responded to the observation within the stipulated timeframe. The Jeedimetla facility manufactures Active pharmaceutical ingredients (APIs) and Pharmaceutical Formulation Intermediates (PFIs).
