News Stocks Cipla's US Subsidiary InvaGen Receives 2 USFDA Observations Following Pre-Approval InspectionCipla's US Subsidiary InvaGen Receives 2 USFDA Observations Following Pre-Approval Inspection
Cipla Limited's wholly owned US subsidiary InvaGen Pharmaceuticals received 2 inspection observations in Form 483 from the USFDA following a Pre-Approval Inspection conducted from February 2nd to 9th, 2026 at its Hauppauge, New York manufacturing facility. The company has committed to working closely with the USFDA to address these observations comprehensively within the stipulated timeframe and has notified stock exchanges as per regulatory requirements.
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Cipla Limited has notified stock exchanges regarding USFDA inspection observations received by its US subsidiary InvaGen Pharmaceuticals. The regulatory development comes following a Pre-Approval Inspection conducted at the company's New York manufacturing facility.
Inspection Details and Timeline
The United States Food and Drug Administration conducted a Pre-Approval Inspection at InvaGen Pharmaceuticals' manufacturing facility located in Hauppauge, Long Island, New York, USA. The inspection was carried out over an eight-day period from February 2nd to 9th, 2026.
| Parameter: | Details |
|---|---|
| Inspection Type: | Pre-Approval Inspection (PAI) |
| Facility Location: | Hauppauge, Long Island, New York, USA |
| Inspection Duration: | February 2nd to 9th, 2026 |
| Subsidiary Status: | Wholly owned subsidiary of Cipla Limited |
USFDA Observations Received
Upon conclusion of the inspection, InvaGen Pharmaceuticals received 2 inspection observations documented in Form 483. Form 483 is the standard document used by the USFDA to communicate observations noted during facility inspections that may constitute violations of the Food, Drug and Cosmetic Act and related regulations.
Company Response and Commitment
Cipla has indicated its commitment to addressing the inspection observations comprehensively. The company stated it will work closely with the USFDA to resolve the identified issues within the stipulated timeframe. This collaborative approach demonstrates the company's focus on maintaining regulatory compliance for its US operations.
Regulatory Disclosure
The notification was made pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. Company Secretary Rajendra Chopra signed the disclosure document on February 10th, 2026, ensuring timely communication to all relevant stock exchanges including BSE Limited, National Stock Exchange of India Limited, and Societe de la Bourse de Luxembourg.
Historical Stock Returns for Cipla
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| +0.75% | +3.13% | -7.72% | -8.96% | -7.28% | +60.69% |
