The regulator has issued an import alert on the Rodopi unit in Greece operated by Pharmathen, which supplies Lanreotide injection to Cipla.
Lanreotide, a treatment used in tumour-related conditions, is among Cipla’s top three products in the US market and commands a market share of around 22%.
The development is major as Cipla had already flagged potential supply disruptions for the product, with management indicating that challenges could persist into the first half of FY27.
The company had also cut its FY26 margin guidance by 175 to 300 basis points, citing issues related to Lanreotide supplies.
The regulatory action follows a series of developments at the Pharmathen facility.
The US FDA had issued nine observations after an inspection in November 2025, followed by an “Official Action Indicated” classification in February 2026.
The latest import alert in April escalates regulatory scrutiny.
Under Import Alert 66-40, the FDA can detain shipments without physical examination from facilities that fail to comply with current Good Manufacturing Practices.
Such facilities are placed on a red list, requiring them to demonstrate corrective measures and often undergo multiple compliant shipments before normal exports can resume.
