Cipla's Top Product in US Market, Lanreotide, Faces Supply Disruption Due to USFDA Inspection at Pharmathen's Manufacturing Facility

Cipla Ltd. has announced an update regarding the supply observations in Form 483 on Pharmathen International S.A., the manufacturer and exclusive supplier of Lanreotide Injection to Cipla USA Inc. The USFDA conducted an inspection at Pharmathen’s Rodopi, Greece manufacturing facility from 10th November 2025 to 21st November 2025, resulting in 9 inspectional observations. The redacted version of Form 483 was made public on 7th January 2026, leading to media reports and material price movement in the Company’s share price. Cipla, through its subsidiary Cipla USA Inc., has been informed that production has been temporarily paused to support ongoing remediation efforts. The re-supply of Lanreotide to the market is expected to resume in H1 of FY 2026-27, with limited supply until manufacturing restarts, subject to quality clearance.