Granules India receives two observations from USFDA

Granules India informed the bourses on February 15, 2020 (Saturday) that US Food and Drug Administration (USFDA) has completed inspection of its facility in Gagillapur located in Hyderabad (Telangana) on February 14, 2020, and have issued two observations. The company assured that it would respond to these observations within the stipulated time.

Commenting on USFDA Audit, Krishna Prasad, Chairman and Managing director of Granules India stated that the company had successfully completed an FDA audit with two observations, which are being addressed and will respond to FDA within the stipulated time. He further stated that the observations will not affect their business continuity.

Granules India is a pharmaceutical company, having a presence across the pharmaceutical manufacturing value chain, including Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediaries (PFIs) and Finished Dosages (FDs). The company now has a total of 23 ANDA approvals from USFDA, including 21 final approvals and two tentative approvals.

At 12.45 pm on Monday, the stock was trading at Rs 176.50, up by 0.48 per cent or Rs 0.85 per share. The 52-week high is recorded at Rs 179.55 and the 52-week low is Rs 84.25 on BSE.