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Cipla's Lanreotide Supply Paused; Resumption Expected H1 FY27 Post USFDA Observations

Cipla Limited

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January 14, 2026, 05:40 PM

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Cipla Limited has provided an update regarding the supply of Lanreotide Injection, a key product for its US subsidiary, Cipla USA Inc. The US Food and Drug Administration (USFDA) conducted an inspection at Pharmathen International S.A., the manufacturer and exclusive supplier of Lanreotide Injection, from November 10 to November 21, 2025. During this inspection, nine observations were issued in Form 483. Following the public release of a redacted Form 483 on January 7, 2026, and subsequent media circulation, the company's share price experienced a material movement.

Cipla USA Inc. has been informed that Pharmathen has temporarily paused production to address the remediation efforts. The resumption of Lanreotide supply to the market is anticipated in the first half of the Financial Year 2026-27. During this period of paused manufacturing, the product will be available in limited supply, contingent upon quality clearance. Cipla Limited is actively monitoring supply levels and is committed to ensuring a stable and reliable supply of Lanreotide as quickly as possible.

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