Mumbai: Cipla Limited has informed the stock exchanges that the US Food and Drug Administration (USFDA) has classified the recent current Good Manufacturing Practices (cGMP) inspection at the Rodopi, Greece manufacturing facility of Pharmathen International S.A. as Official Action Indicated (OAI).
The inspection pertains to the Rodopi, Greece site of Pharmathen International S.A., which serves as the supply partner for Lanreotide Injection to Cipla USA Inc., a wholly owned subsidiary of Cipla Limited.
The company disclosed that this update is in continuation of its earlier intimations dated January 7 and January 14, 2026, regarding the USFDA inspection at the said facility. The OAI classification indicates that the US regulator has identified objectionable conditions during the inspection that warrant regulatory or administrative action.
Cipla, in its regulatory filing dated February 21, 2026, addressed to BSE Limited, the National Stock Exchange of India Limited, and the Societe de la Bourse de Luxembourg, stated that it has been informed about the inspection outcome by its supply partner.
The Rodopi facility plays a role in the manufacturing and supply of Lanreotide Injection for the US market through Cipla USA Inc. Lanreotide is a long-acting injectable formulation used in the management of certain hormonal disorders and neuroendocrine tumors.
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