Cipla: USFDA Inspection at Subsidiary Pharmathen's Facility Classified as OAI

1 min read Updated on 21 Feb 2026, 06:35 PM

Reviewed by

Naman SScanX News Team

Overview

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

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Cipla GST Department Inspection Concludes With No Material Impact

1 min read Updated on 10 Feb 2026, 03:19 PM

Reviewed by

Jubin VScanX News Team

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Overview

Cipla Limited has successfully concluded GST Department inspection proceedings that began on February 5, 2026 and ended on February 7, 2026. The company provided full cooperation and all necessary documentation to authorities, with no official orders issued and no material impact on financials or operations confirmed.

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Cipla Limited has informed stock exchanges that the Goods & Service Tax Department, Maharashtra concluded their inspection and search proceedings on February 7, 2026 at 2200 hours (IST). The pharmaceutical company made this disclosure under Regulation 30 of the SEBI Listing Obligations and Disclosure Requirements Regulations, 2015, confirming no material impact on the company's financials or operations.

Inspection Timeline and Conclusion

The GST Department inspection, which began on February 5, 2026 at 1230 hours, was successfully concluded within two days. The proceedings were conducted under Section 67 of the Maharashtra Goods & Service Tax Act, 2017, covering both inspection under sub-section (1) and search under sub-section (2).

Timeline Details:	Information
Inspection Start:	February 5, 2026 at 1230 hours
Inspection Conclusion:	February 7, 2026 at 2200 hours (IST)
Duration:	2 days
Authority:	Deputy Commissioner of State Tax, Maharashtra
Legal Framework:	Section 67 of Maharashtra GST Act, 2017

Company Cooperation and Documentation

Cipla has confirmed that it provided all necessary documents, clarifications and details as requested by the authorities during the inspection process. The company extended full cooperation throughout the proceedings, demonstrating its commitment to regulatory compliance and transparency. Notably, no official document has been issued by the authorities following the conclusion of the inspection.

Impact Assessment

The company has categorically stated that there is no material impact on its financials, operations or other activities due to the inspection and search proceedings. This outcome aligns with the company's earlier assessment when the inspection was initiated, where it had anticipated no financial impact from the proceedings.

Impact Analysis:	Status
Financial Impact:	No material impact
Operational Impact:	No material impact
Official Orders:	No official document issued
Company Cooperation:	Full cooperation extended
Documentation:	All requested documents provided

Regulatory Compliance

The disclosure was made pursuant to SEBI Listing Regulations and follows the format specified in SEBI Circular no. SEBI/HO/CFD/PoD2/CIR/P/0155 dated November 11, 2024. Company Secretary Rajendra Chopra signed the disclosure document on February 8, 2026, ensuring timely compliance with regulatory requirements for transparency in material events.

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