An inspection was conducted by the United States Food and Drug Administration (USFDA) at the manufacturing facility of InvaGen Pharmaceuticals, wholly owned subsidiary of Cipla Ltd (InvaGen) located in Central Islip, Long Island, New York, USA, from 11th September, 2023 to 19th September, 2023. The inspection was a routine current Good Manufacturing Practices (cGMP) inspection and a Pre-Approval Inspection (PAI) for a site transfer product within InvaGen.

On conclusion of the inspection, InvaGen has received 5 inspectional observations in Form 483. There are no repeat or data integrity (DI) observations. The Company will work closely with the USFDA and is committed to address these comprehensively within stipulated time.