Cipla Evaluates US FDA Form 483 Observations on Supply Partner Pharmathen
Cipla Ltd clarified FDA inspectional observations on supply partner Pharmathen International SA following stock exchange queries. The FDA inspection at Pharmathen's Greece facility from November 10-21, 2025, resulted in nine Form 483 observations including contamination control issues, sterile condition deficiencies, and laboratory control shortcomings. Pharmathen manufactures lanreotide injection for Cipla's US operations, and the company is evaluating the impact while shares declined 4.28% to ₹1,465.30.
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Cipla Ltd has issued a clarification regarding media reports on inspectional observations issued by the US Food and Drug Administration to its supply partner Pharmathen International SA. The pharmaceutical company received communication from stock exchanges seeking clarification on reports related to FDA inspectional observations recorded in Form 483.
Partnership and Product Details
Pharmathen serves as Cipla's supply partner and manufactures lanreotide injection for Cipla USA Inc, a wholly-owned subsidiary of the company. The Greece-based contract manufacturing organisation has partnered with Cipla to commercialise the tumour drug lanreotide in the US market.
FDA Inspection Findings
The FDA conducted an inspection at Pharmathen's manufacturing facility in Rodopi, Greece, from November 10 to November 21, 2025. Following the inspection, Pharmathen received nine inspectional observations, which became public on January 7, 2026.
| Observation Category | Details |
|---|---|
| Contamination Control | Inadequate procedures to prevent contamination |
| Sterile Conditions | Weak control systems to ensure sterility |
| Processing Areas | Deficiencies in aseptic processing areas |
| Laboratory Controls | Shortcomings including absence of appropriate procedures |
| Quality Assurance | Failures in establishing adequate processes for purity and quality |
| Testing Procedures | Lapses in following approved sampling plans and testing |
| Facility Condition | Buildings used for manufacturing found in poor condition |
Company Response and Impact Assessment
Cipla stated it is currently evaluating the impact of the inspectional observations and will keep stock exchanges informed of any developments that may have a material impact, in line with applicable regulatory requirements. The company emphasized that it received these details through media reports and subsequent exchange queries.
Understanding Form 483
A Form 483 represents a list of observations made during FDA inspections and is issued by FDA inspectors after completion of the inspection process. The inspector communicates and explains these observations to the supplier during the closing conference. However, Form 483 does not represent a final FDA determination regarding the facility's Good Manufacturing Practice (GMP) compliance.
After Form 483 issuance, companies receive 15 days to submit their response to the FDA, explaining steps they will take to resolve the observations.
Market Impact
| Parameter | Details |
|---|---|
| Closing Price | ₹1,465.30 |
| Daily Change | -₹65.50 |
| Percentage Decline | -4.28% |
| Trading Date | January 7 |
Shares of Cipla Ltd ended at ₹1,465.30, declining by ₹65.50 or 4.28% on the BSE on January 7, reflecting investor concerns over the regulatory observations affecting its supply partner.
Historical Stock Returns for Cipla
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| -0.50% | -3.35% | -3.96% | -3.30% | -2.46% | +76.71% |
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