Biocon Bengaluru unit pre-approval inspection by USFDA concludes with zero observations
20 Jan 2020

NEW DELHI: Biocon on Monday said that pre-approval inspection of the Bengaluru facility of its arm conducted by US health regulator was concluded with zero observations. The US Food and Drug Administration (USFDA) conducted a pre-approval inspection of the oral solid dosage manufacturing facility of Biocon Pharma, a subsidiary of Biocon, which was triggered by the submission of an abbreviated new drug application, the company said in a regulatory filing.