Cipla Announces Temporary Supply Pause for Lanreotide Following USFDA Audit of Partner Facility

Following the USFDA inspection of Pharmathen International S.A.’s manufacturing facility in Rodopi, Greece, which resulted in nine inspectional observations in Form 483, Cipla USA Inc. This has been notified of a temporary suspension in the production of Lanreotide Injection. As a critical top-three product for Cipla in the US market, this pause is a strategic measure to support Pharmathen’s ongoing remediation efforts aimed at addressing the regulatory findings. The public release of the redacted Form 483 on January 7, 2026, triggered significant media attention and market volatility, prompting the company to provide this clear roadmap for supply restoration. While production is paused, existing stock remains in limited supply and is strictly subject to quality clearance before reaching the market.

Cipla is working closely with its exclusive supplier to expedite the remediation process, with the current projection for re-supply to resume in the first half of the fiscal year 2026-27. In the interim, the company is actively monitoring inventory levels and distribution to mitigate the impact on patients and healthcare providers. This commitment to transparency and quality underscores Cipla’s focus on long-term regulatory compliance and the eventual return to a stable, reliable supply chain for this vital medication. The company remains dedicated to fulfilling its obligations under SEBI regulations while navigating these technical and operational challenges at the partner manufacturing site.

About the Company

Cipla Ltd. is a prominent pharmaceutical company engaged in the business of pharmaceuticals, holding a significant market leadership position in India. It ranks as the 3rd largest player in the domestic Rx market and holds the top position in the Respiratory segment, while also being among the top 5 in Urology and Anti-infectives. With a substantial field force of over 7,500 professionals reaching a vast network of healthcare professionals, Cipla boasts a diversified product portfolio encompassing over 1,500 products across more than 50 dosage forms and 65 therapeutic categories, demonstrating its global reach and commitment to introducing new medicines, with 93 product launches.

The company has a market cap of over Rs 1 lakh crore and the stock is up by 11 per cent from its 52-week low of Rs 1,310.05 per share.

Disclaimer: The article is for informational purposes only and not investment advice.