Cipla: USFDA Inspection at Subsidiary Pharmathen's Facility Classified as OAI
Cipla Limited disclosed that the USFDA has classified the cGMP inspection at its subsidiary Pharmathen International S.A.'s facility in Rodopi, Greece as Official Action Indicated (OAI). The facility serves as a supply partner for Lanreotide Injection to Cipla USA Inc. and the classification indicates significant regulatory issues requiring corrective action.
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Cipla Limited has received an Official Action Indicated (OAI) classification from the US Food and Drug Administration (USFDA) for its subsidiary manufacturing facility in Greece. The pharmaceutical company disclosed this regulatory development to stock exchanges on 21st February, 2026.
USFDA Inspection Classification
The USFDA has classified the current Good Manufacturing Practices (cGMP) inspection at the Rodopi, Greece manufacturing facility of Pharmathen International S.A. as Official Action Indicated. This classification indicates that the regulatory authority has identified significant issues during its inspection that require corrective action.
| Parameter: | Details |
|---|---|
| Facility Location: | Rodopi, Greece |
| Subsidiary Company: | Pharmathen International S.A. |
| Inspection Type: | cGMP (current Good Manufacturing Practices) |
| Classification: | Official Action Indicated (OAI) |
| Product Supplied: | Lanreotide Injection |
Subsidiary Operations
Pharmathen International S.A. operates as a subsidiary facility that supplies Lanreotide Injection to Cipla USA Inc., which is a wholly owned subsidiary of Cipla Limited. The Greece-based facility plays a crucial role in the company's supply chain for this pharmaceutical product in the US market.
Regulatory Communication Timeline
This update represents a continuation of ongoing regulatory communications. Cipla had previously informed exchanges about developments related to this facility through intimations dated 7th and 14th January, 2026. The company has maintained transparency with stakeholders regarding the inspection process and its outcomes.
Official Disclosure
The information was formally communicated to multiple stock exchanges including BSE Limited, National Stock Exchange of India Limited, and Societe de la Bourse de Luxembourg. Company Secretary Rajendra Chopra signed the official communication, ensuring compliance with regulatory disclosure requirements under Regulation 30.
Historical Stock Returns for Cipla
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| +0.92% | +0.83% | -3.68% | -13.42% | -8.40% | +66.11% |
