Biocon's Small Molecules API Manufacturing Facility Completes Post-Approval and GMP U.S. FDA Inspection

Bengaluru, Karnataka, India, Feb 27, 2020

“This is to inform you that the U.S. Food and Drug Administration (FDA) conducted a Post-Approval and GMP inspection of our Small Molecules API Manufacturing Facility at 20^th KM, Biocon Campus, Bengaluru, between Feb 20 and Feb 26, 2020.

At the conclusion of the inspection the agency issued a Form 483, with two observations, which are procedural in nature. We are confident of addressing these observations expeditiously and will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) in a timely manner.

We remain committed to global standards of Quality and Compliance”

- Company Spokesperson