Cipla Clarifies On USFDA Form 483 Observations At Pharmathen Facility

Cipla Ltd has responded to media reports concerning inspectional observations issued by the US Food and Drug Administration (USFDA) to Pharmathen International SA, its supply partner for lanreotide injection. The inspection, conducted in November 2025 at Pharmathen’s Greece facility, resulted in nine Form 483 observations, highlighting deficiencies in contamination control, sterile manufacturing practices, and laboratory procedures.  

Cipla clarified that Pharmathen manufactures lanreotide injection for Cipla USA Inc, a wholly-owned subsidiary. The company stated it is currently assessing the impact of these observations and will keep stock exchanges informed of any material developments. Shares of Cipla fell nearly 4 percent following the news, reflecting investor concerns over regulatory compliance and potential supply chain implications.  

Key Highlights  

• USFDA issued nine Form 483 observations to Pharmathen’s Greece facility  
• Observations include contamination control and sterile manufacturing deficiencies  
• Pharmathen supplies lanreotide injection to Cipla USA Inc  
• Cipla evaluating impact and committed to informing exchanges of updates  
• Cipla shares declined around 4 percent after reports surfaced  

Final Takeaway  
Cipla’s clarification underscores its proactive communication with stakeholders amid regulatory scrutiny of its supply partner. While the company is assessing the impact, investor sentiment reflects caution, highlighting the importance of compliance in sustaining global pharmaceutical operations.  

Sources: Reuters, CNBC-TV18, Moneycontrol