USFDA Concludes PAI at Cipla Subsidiary InvaGen With 2 Observations

The company clarified that the inspection was part of the pre-approval process undertaken by the US health regulator to assess compliance with current good manufacturing practices before granting approvals for drug applications. InvaGen Pharmaceuticals is a wholly owned subsidiary of Cipla and is an important part of the company’s US generics operations.

Cipla stated that it will work closely with the USFDA to address the two observations comprehensively within the stipulated timelines. The company emphasized its commitment to taking all necessary corrective and preventive actions to meet regulatory expectations.

Cipla reiterated its focus on maintaining high standards of quality and regulatory compliance across its global manufacturing network and said it remains engaged with regulators to ensure timely resolution of inspection-related matters.