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FDA Cites Pharmathen Facility for Major Compliance Lapses
7 Jan
Summary
- FDA observed multiple compliance gaps at Pharmathen's facilities.
- Concerns include inadequate contamination prevention and weak sterile controls.
- Cipla's stock declined due to regulatory action against its partner.
On January 7, 2026, Cipla Ltd. experienced a stock decline of approximately 2% due to regulatory scrutiny faced by its partner, Pharmathen International. The US Food and Drug Administration (FDA) detailed observations highlighting multiple compliance gaps at Pharmathen's manufacturing sites.
Critical deficiencies noted by the FDA include insufficient procedures to prevent contamination and weak control systems for maintaining sterile drug production. The regulator also identified issues in aseptic processing areas and laboratory controls, indicating a lack of appropriate procedures to ensure drug purity and quality.
Furthermore, the FDA reported that the buildings used for manufacturing were in poor condition. These findings have raised concerns among investors about the Lanreotide commercialization partnership between Cipla and Pharmathen in the US market, leading to a dip in Cipla's share value.
