USFDA Concludes PAI at Cipla Subsidiary InvaGen With 2 Observations
New Delhi: Cipla Limited has informed the stock exchanges that the United States Food and Drug Administration (USFDA) conducted a Pre-Approval Inspection (PAI) at the manufacturing facility of InvaGen Pharmaceuticals, Inc., a wholly owned subsidiary of the company, located in Hauppauge, Long Island, New York, USA.
The inspection was carried out from February 2, 2026, to February 9, 2026.
In a regulatory disclosure, Cipla stated that the inspection concluded with the issuance of two inspectional observations by the USFDA. These observations were communicated to the company in Form 483 at the end of the inspection.
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.
