Cipla Partner Pharmathen Receives 9 USFDA Observations
Cipla had earlier received final USFDA approval in May 2024 to market its generic Lanreotide injection in multiple strengths.
Mumbai: The U.S. Food and Drug Administration (USFDA) has issued inspectional observations at the manufacturing facility of Pharmathen International SA, a key supply partner for Cipla Ltd, flagging multiple compliance-related issues.
Pharmathen, which manufactures Lanreotide Injection for Cipla USA Inc., a wholly owned subsidiary of Cipla, was inspected by the US FDA at its facility located in Rodopi, Greece, between November 10 and November 21, 2025.
Following the inspection, the regulator issued a Form 483 with nine observations.
Cipla, in a regulatory filing, clarified that Pharmathen is its supply partner for Lanreotide Injection and that the inspection findings relate to Pharmathen’s manufacturing operations. The company said it received queries from stock exchanges seeking clarification on media reports related to the US FDA observations and responded accordingly.
According to a recent media report in MoneyControl, the US FDA identified shortcomings including inadequate contamination control measures, weaknesses in sterile manufacturing systems, and deficiencies in laboratory procedures and controls. The inspection also noted gaps in aseptic processing areas, lack of adequate procedures to ensure product purity and quality, and shortcomings in adherence to approved sampling and testing protocols.
The Form 483 reportedly flagged “objectionable conditions and practices,” including the presence of visible particles in a drug product and failure to adequately investigate and identify their source. The regulator further pointed out the absence of procedures governing the review of raw electronic data generated by computerised systems used in Good Manufacturing Practice (GMP) operations, along with weaknesses in contamination-prevention practices and maintenance of aseptic processing areas.
Cipla stated that it is currently evaluating the impact of the US FDA observations and will keep the stock exchanges informed of any developments that may have a material impact, in line with applicable regulatory requirements.
Pharmathen’s facility in Sapes, Rodopi, which is approved by the US FDA and has undergone multiple inspections in the past, manufactures Lanreotide acetate injection along with several other generic medicines.
Cipla had received final US FDA approval in May 2024 to market its generic Lanreotide injection in multiple strengths for the U.S. market. According to IQVIA (IMS Health) data cited in MoneyControl, Lanreotide recorded U.S. sales of approximately $898 million in the 12 months ended March 2024.
