Cipla Clarifies USFDA Inspectional Observations on Supply Partner Pharmathen
Cipla Limited issued a regulatory clarification regarding USFDA inspectional observations on its supply partner Pharmathen International S.A. The USFDA conducted an inspection at Pharmathen's manufacturing facility in Rodopi, Greece, resulting in nine observations. Pharmathen manufactures Lanreotide Injection for Cipla USA Inc., and the company is currently evaluating the impact while committing to provide updates on any material developments.

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Cipla Limited has issued a clarification regarding USFDA inspectional observations on its supply partner Pharmathen International S.A., following media reports about regulatory concerns at the Greek manufacturing facility.
USFDA Inspection Details
The US Food and Drug Administration conducted an inspection at Pharmathen's manufacturing facility in Rodopi, Greece. The inspection resulted in nine inspectional observations being issued to the company.
| Inspection Parameter: | Details |
|---|---|
| Facility Location: | Rodopi, Greece |
| Inspection Period: | November 10-21, 2025 |
| Observations Issued: | 9 inspectional observations |
| Form 483 Public Date: | January 7, 2026 |
Cipla's Business Relationship
Cipla clarified that Pharmathen serves as a supply partner, specifically manufacturing Lanreotide Injection for Cipla USA Inc., which is a wholly owned subsidiary of the company. The clarification was made under Regulation 30(11) of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
The company received communication from stock exchanges seeking clarification on media reports about the USFDA observations, prompting the formal disclosure.
Company Response and Impact Assessment
Cipla stated it is currently evaluating the impact of the USFDA observations on Pharmathen's facility. The company has committed to keeping stock exchanges informed of any updates that may have material impact, in accordance with applicable regulatory requirements.
| Regulatory Compliance: | Status |
|---|---|
| Disclosure Regulation: | SEBI LODR Regulation 30(11) |
| Exchange Notification: | BSE, NSE, Luxembourg |
| Impact Assessment: | Under evaluation |
| Future Updates: | As per regulatory requirements |
The clarification was signed by Company Secretary Rajendra Chopra and filed with BSE Limited, National Stock Exchange of India Limited, and SOCIETE DE LA BOURSE DE Luxembourg, covering all relevant stock exchanges where Cipla securities are listed.
Historical Stock Returns for Titan
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| -0.57% | +4.87% | +11.43% | +15.90% | +21.22% | +175.49% |
















































