Cipla has received notification that the US Food and Drug Administration (USFDA) has classified the current Good Manufacturing Practices (cGMP) inspection at Pharmathen International S.A. in Greece as ‘Official Action Indicated’ (OAI). Pharmathen is the supply partner for Cipla USA Inc.’s Lanreotide Injection. This update follows previous intimations made by Cipla on January 7th and 14th, 2026, concerning the status of the inspection at the Rodopi facility.
USFDA Inspection Outcome Update
Cipla Limited announced on 21st February, 2026, that it has been informed of the outcome of the US Food and Drug Administration (USFDA) inspection conducted at its supply partner’s facility. The inspection targeted the manufacturing operations of Pharmathen International S.A., located in Rodopi, Greece.
Impact on Lanreotide Supply
The USFDA has classified the current Good Manufacturing Practices (cGMP) inspection findings as ‘Official Action Indicated’ (‘OAI’). Pharmathen International S.A. is the crucial supply partner responsible for providing the Lanreotide Injection product to Cipla USA Inc., which is a wholly owned subsidiary of Cipla.
Context and Reference
This formal communication serves as an update in continuation of the initial intimations provided by the Company on 7th and 14th January, 2026, regarding the ongoing inspection process at the Greek manufacturing site. Cipla acknowledges this information and has taken the necessary regulatory step to record the OAI status with all relevant listing exchanges.
Source: BSE
