Cipla Clarification on USFDA Inspectional Observations at Pharmathen Facility

Cipla has addressed media reports concerning US Food and Drug Administration (USFDA) inspectional observations at the manufacturing facility of its supply partner, Pharmathen International S.A., in Rodopi, Greece. The inspection, which concluded on November 21, 2025, resulted in nine observations. Cipla is currently assessing the potential impact and will keep the Stock Exchanges informed of any material updates.

Clarification on Pharmathen Inspection

Cipla has issued a clarification regarding recent media coverage of US Food and Drug Administration (USFDA) inspectional observations at the Pharmathen International S.A. facility. Pharmathen is a key supply partner for Cipla USA Inc.

Inspection Details

The USFDA conducted an inspection at Pharmathen’s manufacturing facility in Rodopi, Greece, from November 10, 2025, to November 21, 2025. Following this inspection, Pharmathen received nine (9) inspectional observations, which were documented on Form 483 that became public on January 7, 2026.

Cipla’s Assessment

Cipla is currently evaluating the impact of these observations and is committed to keeping the Stock Exchanges informed of any updates that may have a material impact on the company.

Source: BSE

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