Cipla has clarified that Pharmathen International S.A., a supply partner, received nine inspectional observations from the US Food and Drug Administration (USFDA) following an inspection at its manufacturing facility in Rodopi, Greece, conducted in November 2025. The inspection, which took place from November 10th to 21st, 2025, resulted in these observations. Cipla is currently assessing the impact of this event.
Pharmathen Inspection Details
Cipla has issued a clarification regarding recent media reports concerning US Food and Drug Administration (USFDA) inspectional observations related to Pharmathen International S.A. Pharmathen, as Cipla clarifies, is a supply partner involved in manufacturing Lanreotide Injection for Cipla USA Inc., a wholly owned subsidiary of Cipla.
USFDA Inspection Findings
The USFDA conducted an inspection at Pharmathen’s manufacturing facility located in Rodopi, Greece, from November 10th to 21st, 2025. As a result of this inspection, Pharmathen received nine inspectional observations. The initial media reports became public on January 7th, 2026.
Cipla’s Evaluation
Cipla is currently evaluating the impact of these inspectional observations and will keep the Stock Exchanges informed of any updates that may have a material impact on the company. This is in accordance with the applicable regulatory requirements.
Source: BSE
