Cipla has provided an update on the supply of Lanreotide Injection following a USFDA inspection at Pharmathen’s Rodopi, Greece facility. The inspection resulted in observations, leading to a temporary pause in production. Re-supply is expected to resume in H1 of FY 2026-27, with supply remaining limited until manufacturing restarts and quality clearance is obtained. Cipla is committed to closely monitoring supply levels.
Lanreotide Supply Update
Cipla has announced an update regarding the supply of Lanreotide Injection following a US Food and Drug Administration (USFDA) inspection at Pharmathen International S.A.’s manufacturing facility in Rodopi, Greece.
USFDA Inspection Findings
The USFDA conducted an inspection at Pharmathen’s Rodopi facility from November 10, 2025 to November 21, 2025, issuing 9 inspectional observations in Form 483. A redacted version of the Form 483 was made public on January 7, 2026, leading to media reports which impacted the company’s share price.
Production Pause and Resupply
Following the inspection and discussions with Pharmathen, production has been temporarily paused to allow for ongoing remediation efforts. Cipla expects the re-supply of Lanreotide to resume in H1 of FY 2026-27. Until manufacturing restarts, the product’s supply will remain limited and subject to quality clearance. Cipla will monitor supply levels closely and is committed to restoring a stable and reliable supply of Lanreotide.
Lanreotide’s Significance
Pharmathen is the manufacturer and exclusive supplier of Lanreotide Injection to Cipla USA Inc., a wholly owned subsidiary of Cipla in the US. Lanreotide is among Cipla’s top three products in the US market.
Source: BSE
