Cipla
Cipla stock rattled as US FDA observations hit crucial drug supply chain
Mumbai/IBNS: Shares of Cipla Limited remained under pressure on Monday after the U.S. Food and Drug Administration classified the cGMP inspection of Pharmathen International SA’s manufacturing facility in Rodopi, Greece, media reports said.
Following its inspection in November 2025, the US FDA issued nine Form 483 observations, raising concerns over contamination risks, aseptic process deficiencies, and potential data integrity issues.
Pharmathen operates as a contract development and manufacturing organisation (CDMO) for global pharmaceutical companies and supplies complex formulations, including key products for Cipla.
It serves as Cipla’s exclusive supply partner for Lanreotide injection in the United States, making the regulatory observations particularly significant for the Indian drugmaker’s supply chain.
Cipla has indicated that its fourth quarter is likely to remain challenging, as it does not expect any sales of generic Revlimid or Lanreotide during the period.
The company has also revised its margin guidance downward to 21%, marking the second reduction from its earlier projection of 22.5% for the ongoing financial year.
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