Cipla has announced a temporary suspension of Lanreotide manufacturing following the USFDA's issuance of Form 483 to Pharmathen's Greece facility. The pharmaceutical major disclosed this development in an exchange filing, highlighting potential supply chain implications for one of its key revenue drivers in the US market.

USFDA Form 483 and Production Halt Details

The manufacturing pause affects Lanreotide production at Pharmathen's Rodopi facility in Greece, after the USFDA issued Form 483 following an inspection that resulted in observations. Pharmathen operates as Cipla's contract manufacturer (CDMO) and serves as the exclusive supplier of Lanreotide to the Indian pharmaceutical company.

US Market Significance

Lanreotide represents one of Cipla's top three products in the US market, where the company maintains a substantial 22.00% market share for this drug. The US market holds strategic importance for Cipla, contributing 27.00% to the company's topline with record sales of $934.00 million.

Company Response and Timeline

Cipla emphasized its commitment to restoring stable supply, stating in the filing that the company will closely monitor supply levels and is fully committed to restoring stable, reliable supply of Lanreotide expeditiously. The re-supply of Lanreotide is expected to resume in the first half of financial year 2027.

Remediation Efforts

The temporary production halt is part of USFDA remediation efforts at the facility. Cipla is working closely with Pharmathen to address the observations raised in Form 483 and ensure compliance with regulatory requirements before resuming production.

Cipla faces a temporary disruption in its lanreotide supply chain following regulatory action by the US Food and Drug Administration. The pharmaceutical giant has announced that production of the drug has been paused due to compliance issues at a key manufacturing facility.

Regulatory Action Details

The USFDA has issued a Form 483 to Pharmathen's manufacturing plant located in Greece. Form 483 is a regulatory document that lists observations of conditions or practices that may violate FDA regulations, typically issued following facility inspections.

Production and Supply Timeline

The regulatory compliance issues have necessitated a temporary halt in lanreotide production at the Greece facility. Cipla has provided guidance on when normal supply operations are expected to resume.

The company anticipates that lanreotide supply will be restored during the first half of FY27, indicating a significant timeline for addressing the regulatory concerns and resuming normal manufacturing operations.

Impact on Operations

This development affects Cipla's lanreotide supply chain, a drug used in various therapeutic applications. The pause in production at Pharmathen's Greece plant represents a notable operational challenge for the pharmaceutical company's product portfolio.

The timeline for supply restoration suggests that resolving the compliance issues identified in the Form 483 will require substantial remedial measures and subsequent regulatory approval before manufacturing can recommence.