The drugmaker’s Granules facility in Gagilpur, Hyderabad has received three observations upon completion of an inspection by the US Food and Drug Administration (US FDA).
“The Gagilapur facility has completed US FDA’s pre-approval inspection (PAI) from January 9-13 with three observations. The company will respond to the comments within the stipulated time period,” Granules said in a filing to the stock exchange on Saturday. This facility manufactures Finished Dosage (FD) and Pharmaceutical Formulation Intermediates (PFIs).