Lanreotide production paused as supply partner facing US FDA check - Cipla
This story was originally published at 10:53 IST on 15 January 2026
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--Cipla: Expect supply of Lanreotide to resume in Apr-Sept
--Cipla: Pharmathen says Lanreotide production shut amid remediation efforts
HYDERABAD – Cipla Ltd. Thursday said the production of one of its key drugs, Lanreotide injection, will be paused as its supply partner Pharmathen International S.A. is currently engaged in the remediation process of its plant at Rodopi, Greece. Lanreotide is used to treat hormone-related issues along with cancer tumor treatments.
"Re-supply of Lanreotide to the market is expected to resume in H1 (Apr-Sept) of financial year 2026-27. Until manufacturing restarts, the product will remain in limited supply, subject to quality clearance," Cipla said in an exchange filing.
Upon evaluation by the company and discussions with Pharmathen, the company, through its subsidiary Cipla USA Inc., has been informed that production has been temporarily paused to support ongoing remediation efforts. Cipla said it will closely monitor supply levels and is fully committed to restoring a stable, reliable supply of Lanreotide expeditiously. Lanreotide has annual sales of $900 million in the US.
Pharmathen is the manufacturer and exclusive supplier of Lanreotide injection to Cipla USA Inc., a wholly-owned subsidiary of the company in the US. This product is among the company's top three products in the US market.
The US FDA conducted an inspection at the Pharmathen's Rodopi manufacturing facility, from Nov. 10 to Nov. 21 and issued 9 inspectional observations in Form-483.
"The redacted version of Form-483 was made public on Jan. 7, following which media reports were widely circulated across mainstream platforms, resulting in material price movement in the company's share price," Cipla said.
Cipla received the final US FDA approval in May 2024 to market its generic Lanreotide injection in multiple strengths, a product with significant US sales potential. Despite robust demand for the drug, Cipla has been facing supply challenges since 2024.
On Wednesday, Cipla's shares ended at INR 1,434.50 on the National Stock Exchange, down nearly 1% from the previous close. End
US$1 = INR 90.29
Reported by Narayana Krishna
Edited by Vandana Hingorani
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