Last month, the US Food and Drug Administration (US FDA) classified the cGMP inspection of Pharmathen International SA’s manufacturing facility in Rodopi, Greece, as OAI, or Official Action Indicated. Pharmathen is Cipla’s exclusive supply partner for Lanreotide injection in the US.
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The regulator had issued nine Form 483 observations following its inspection in November 2025, including concerns related to contamination risks, aseptic process failures and potential data integrity issues. Lanreotide is Cipla’s largest product in the US market, with a market share of 22% as of the second quarter.Speaking to CNBC-TV18 after its third-quarter results, the company said its partner is undertaking remediation measures and that there is currently no production taking place at the facility.
Management expressed hope that production of Lanreotide would resume by the fourth quarter, although timelines remain subject to regulatory clearance. Some analysts believe resupply could be pushed out to the first half of FY27.
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The company has indicated that the fourth quarter is likely to be challenging, as it will not see sales from either generic Revlimid or Lanreotide. Cipla has also reduced its margin guidance to 21% from 22.5% earlier, marking the second downward revision this year.
Shares of Cipla Ltd ended at ₹1,320.00, down by ₹1.75, or 0.13%, on the BSE.
First Published: Mar 9, 2026 11:42 PM IS
