Jan 08, 2026, 01:32 PM IST
US pharma major Cipla is in focus after the US Food and Drug Administration flagged serious compliance issues at its partner Pharmathen’s manufacturing facility in Greece. The regulator highlighted lapses in contamination control systems at the plant that produces the complex injectable drug Lanreotide, used in the treatment of certain tumors. Lanreotide is a key product for Cipla in the US market, making the observations significant from a business and operational standpoint. The FDA findings could potentially impact production timelines, regulatory approvals and supply continuity until corrective actions are implemented. Cipla’s response and Pharmathen’s remediation measures will be closely tracked, as any prolonged regulatory action could weigh on Cipla’s US formulations business and investor sentiment.
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