Cipla Clarifies USFDA Form 483 Observations on Supply Partner Pharmathen
Cipla has issued a regulatory clarification regarding USFDA inspectional observations received by its supply partner Pharmathen International S.A. The USFDA conducted an inspection at Pharmathen's Greek facility from November 10-21, 2025, resulting in nine observations in Form 483. Pharmathen manufactures Lanreotide Injection for Cipla USA Inc., and the company is currently evaluating the impact while committing to transparent disclosure of any material developments.
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Cipla has issued a clarification regarding USFDA inspectional observations received by its supply partner Pharmathen International S.A., following media reports about Form 483 observations at the Greek manufacturing facility.
USFDA Inspection Details
The US Food and Drug Administration conducted an inspection at Pharmathen International S.A.'s manufacturing facility located in Rodopi, Greece. The inspection resulted in nine inspectional observations being issued to the supply partner.
| Inspection Details: | Information |
|---|---|
| Inspection Period: | November 10-21, 2025 |
| Facility Location: | Rodopi, Greece |
| Form 483 Public Date: | January 7, 2026 |
| Total Observations: | 9 inspectional observations |
| Supply Partner: | Pharmathen International S.A. |
Partnership and Product Impact
Pharmathen International S.A. serves as a supply partner for Cipla, specifically manufacturing Lanreotide Injection for Cipla USA Inc., which is a wholly owned subsidiary of the company. This partnership arrangement highlights the interconnected nature of pharmaceutical supply chains and regulatory oversight.
Company Response and Evaluation
Cipla has stated that it is currently evaluating the impact of the USFDA observations on its operations. The company has committed to keeping stock exchanges informed of any developments that may have a material impact on its business, in accordance with applicable regulatory requirements.
| Regulatory Compliance: | Details |
|---|---|
| Disclosure Regulation: | SEBI LODR Regulation 30(11) |
| Exchange Notification: | BSE, NSE, Luxembourg |
| Current Status: | Impact evaluation in progress |
| Future Updates: | Material impacts to be disclosed |
The clarification was issued following communication from stock exchanges seeking details about media reports regarding the USFDA inspection observations, demonstrating the company's commitment to transparent regulatory disclosure.
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