Granules receives EIR for Hyderabad unit
The US drug regulator has issued Establishment Inspection Report (EIR) to Granules India's Gagillapur facility without any 483 observations, the company informed on Friday.
Granules India's Gagillapur plant is located in Hyderabad, Telangana. The plant manufactures finished dosages (PBS) and pharmaceutical formulation intermediates (PFIS). The US Food and Drug Administration (FDA) inspection was conducted in March 2018. During the same period, the USFDA had also inspected the company's Jeedimetla facilities and issued one Form 483 observation for the unit.
Granules India Limited is an integrated pharmaceutical company engaged in the manufacture of API (Active Pharmaceutical Ingredients), PFIs and PBS for customers based in around 75 countries. The company operates through three major business segments including Core molecule business which consist of Paracetamol, Ibuprofen. etc; Emerging business which manufactures APIs and CRAMS focusing on contract research and manufacturing.
During Friday's early morning session, the stock of Granules India Limited was quoting Rs. 79.00 per share, up by 0.45 per cent on BSE.