Cipla's Lanreotide Supply in US Hit After USFDA Observations at Pharmathen Facility

In its communication, Cipla stated that Pharmathen International S.A., based in Greece, manufactures and exclusively supplies Lanreotide Injection to Cipla USA Inc., a wholly owned subsidiary of Cipla Limited in the United States. The company highlighted that Lanreotide is among Cipla’s top three products in the US market.

Cipla disclosed that the USFDA conducted an inspection at Pharmathen’s Rodopi, Greece manufacturing facility from 10 November 2025 to 21 November 2025. Following the inspection, the USFDA issued nine inspectional observations in Form 483. The redacted version of the Form 483 was made public on 7 January 2026, after which widespread media coverage across mainstream platforms led to material movement in Cipla’s share price.

Subsequently, after evaluating the situation and holding discussions with Pharmathen, Cipla stated that it was informed through its subsidiary Cipla USA Inc. that production of Lanreotide has been temporarily paused. The pause is aimed at supporting ongoing remediation efforts at the manufacturing site in response to the USFDA observations.

The company further clarified that re-supply of Lanreotide Injection is expected to resume in the first half of FY 2026–27. Until manufacturing operations restart and quality clearances are obtained, the product will remain in limited supply in the market.

Cipla emphasized that it is closely monitoring supply levels and reiterated its commitment to restoring a stable and reliable supply of Lanreotide at the earliest.