Pharmathen is Cipla’s exclusive supply partner for Lanreotide injection in the US.
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.
Analysts said that at least one of the observations appears to lean towards data integrity challenges.
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.
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.
Brokerage firm Morgan Stanley has an ‘Underweight’ rating on Cipla with a price target of ₹1,211 per share.
Cipla shares are now trading 0.95% lower at ₹1,328.30. The stock has fallen 12% so far this year and is down 20% from its 52-week high.