Cipla evaluating US FDA Form 483 observations on supply partner Pharmathen

Drug firm Cipla Ltd on Wednesday (January 7) said it has issued a clarification regarding media reports on inspectional observations issued by the US Food and Drug Administration to Pharmathen International SA.

The company said it received communication from the stock exchanges seeking clarification on reports related to FDA inspectional observations in Form 483 on Pharmathen. Cipla stated that Pharmathen is its supply partner and manufactures lanreotide Injection for Cipla USA Inc, a wholly-owned subsidiary of the company.

Cipla said it is currently evaluating the impact of the inspectional observations and will keep the stock exchanges informed of any developments that may have a material impact, in line with applicable regulatory requirements.

According to media reports cited by Cipla, 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, as recorded in Form 483, which became public on January 7, 2026.

These include inadequate procedures to prevent contamination and weak control systems to ensure sterile conditions. The regulator also flagged deficiencies in aseptic processing areas and shortcomings in laboratory controls, including the absence of appropriate procedures.

The FDA further pointed out failures in establishing adequate processes to ensure the purity and quality of drug products, along with lapses in following approved sampling plans and testing procedures. In addition, the buildings used for manufacturing were found to be in poor condition.

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Cipla has a partnership with Pharmathen, a Greece-based contract manufacturing organisation, to commercialise tumour drug lanreotide in the US market.

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What is a Form 483

A Form 483 is a list of observations made during the inspection and is issued by the FDA inspectors after the completion of the inspection. The inspector will communicate and explain these observations to the supplier during the closing conference. But a Form 483 does not represent a final FDA determination regarding the facility’s GMP compliance.

After a Form 483 is issued, the company is given 15 days to submit its response to the FDA explaining what steps the company will take to resolve the observations.

Shares of Cipla Ltd ended at ₹1,465.30, down by ₹65.50, or 4.28%, on the BSE on January 7.

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