The company noted it had received inquiries from stock exchanges seeking clarification regarding the reports on FDA inspectional observations documented in Form 483 concerning Pharmathen. Cipla emphasized that Pharmathen is its supply partner, responsible for producing lanreotide Injection for Cipla USA Inc, a fully-owned subsidiary of Cipla.
Cipla is currently assessing the impact of these inspectional observations and will keep the stock exchanges updated on any developments that could materially affect operations, in accordance with relevant regulatory requirements.
As indicated in media reports referenced by Cipla, the FDA conducted an inspection at Pharmathen’s manufacturing site in Rodopi, Greece, from November 10 to November 21, 2025. Subsequently, Pharmathen received nine inspectional observations recorded in Form 483, which were made public on January 7, 2026.
The observations include inadequate measures to prevent contamination and insufficient control systems to maintain sterile conditions. The FDA also cited deficiencies in aseptic processing areas and noted shortcomings in laboratory controls, including a lack of suitable procedures.
Additionally, the FDA highlighted failures to establish adequate processes for ensuring the purity and quality of drug products, as well as lapses in adhering to approved sampling plans and testing protocols. Furthermore, the buildings utilized for manufacturing were reported to be in poor condition.
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Cipla collaborates with Pharmathen, a Greece-based contract manufacturing organization, to commercialize the tumor drug lanreotide in the US market.
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What is a Form 483
A Form 483 is a compilation of observations made during an inspection and is issued by FDA inspectors upon completing the inspection. The inspector communicates and explains these observations to the supplier during the closing conference. Nonetheless, a Form 483 does not signify a definitive FDA assessment of the facility’s GMP compliance.
After a Form 483 is issued, the company is allotted 15 days to respond to the FDA, detailing the steps it will take to address the observations.
On January 7, shares of Cipla Ltd closed at ₹1,465.30, declining by ₹65.50, or 4.28%, on the BSE.
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(Edited by : Shoma Bhattacharjee)
