Home / Business and Economy / Cipla Pauses Key Drug Production Amid FDA Probe
Cipla Pauses Key Drug Production Amid FDA Probe
16 Jan
Summary
- Cipla temporarily stopped Lanreotide manufacturing to aid USFDA remediation.
- Pharmathen, the exclusive supplier, faced USFDA observations in November 2025.
- Lanreotide supply is expected to resume in the first half of FY2027.
Shares of drugmaker Cipla Ltd. are under scrutiny as the company has announced a temporary pause in the manufacturing of its crucial drug, Lanreotide. This halt is a direct measure to facilitate the USFDA remediation process at the production facility. Lanreotide represents one of Cipla's top three products in the lucrative US market, which significantly contributes to the company's overall revenue.
The disruption stems from a USFDA inspection conducted in November 2025 at the Rodopi facility of Pharmathen, a contract manufacturer and exclusive supplier of Lanreotide to Cipla. The inspection resulted in several observations that necessitate these remedial actions. The company has stated its full commitment to monitoring supply levels and ensuring the swift restoration of stable Lanreotide availability.
Cipla expects the re-supply of Lanreotide to commence in the first half of financial year 2027. This development comes as Cipla holds a substantial 22% market share for Lanreotide in the United States. The stock has experienced a decline in early 2026, reflecting market reactions to this supply chain uncertainty.
