Cipla Limited has disclosed that its wholly owned subsidiary, InvaGen Pharmaceuticals, located in Hauppauge, New York, underwent a Pre-Approval Inspection (PAI) by the USFDA. The inspection took place from February 2nd to February 9th, 2026. Upon completion, InvaGen received two (two) inspectional observations documented on Form 483. Cipla has assured stakeholders that it is committed to comprehensively addressing these observations within the stipulated timeline.
USFDA Inspection Concluded at US Facility
Cipla has informed the stock exchanges regarding the conclusion of a significant regulatory inspection at one of its key overseas manufacturing sites. The Pre-Approval Inspection (PAI) was conducted by the United States Food and Drug Administration (USFDA) at the facility operated by InvaGen Pharmaceuticals, Inc.
InvaGen is a wholly owned subsidiary of Cipla Limited, and the facility is situated in Hauppauge, Long Island, New York, USA. The inspection period was notably short, running from February 2nd, 2026, to February 9th, 2026.
Inspectional Outcomes
The primary outcome of the inspection is the issuance of a Form 483, which details deficiencies noted by the inspecting authority. In this instance, InvaGen has received 2 (two) inspectional observations. The announcement, made on February 10th, 2026, by Company Secretary Rajendra Chopra, confirmed the receipt of these findings.
Commitment to Remediation
Cipla has stated its commitment to regulatory compliance. The Company confirmed that it will collaborate closely with the USFDA and is dedicated to addressing the two observations comprehensively and within the timeframe mandated by the regulator. This commitment underscores the organization’s focus on maintaining high-quality standards across its global manufacturing network.
Source: BSE
