Jeedimetla facility manufactures active pharmaceutical ingredients (APIs) and pharmaceutical formulation intermediates (PFIs)
Granules India announced that the US health regulator has issued the Establishment Inspection Report (EIR) after completing the audit of its Telangana facility.
“The United States Food and Drug Administration (US FDA) has issued the Establishment Inspection Report (EIR) for the company’s Jeedimetla facility located at Hyderabad, Telangana, India,” Granules said in a BSE filing.
The company said this facility was inspected by the USFDA in March 2018 and there was one observation during the inspection. Granules said it has responded to the observation within the stipulated timeframe. Jeedimetla facility manufactures active pharmaceutical ingredients (APIs) and pharmaceutical formulation intermediates (PFIs), the company added.
The USFDA issues an EIR to the establishment that is subject to an FDA or FDA-contracted inspection when the agency decides to close the inspection. The company shares were trading up 2.48 per cent at Rs 97 on the BSE.