Cipla shares slipped as much as 4.60% on Friday to hit an intraday low of Rs 1,367.80 apiece on the BSE after the company temporarily paused manufacturing of Lanreotide Injection, one of its top three products in the US market. The pressure on the stock followed disclosure of supply disruptions stemming from inspectional observations issued by the USFDA at a third-party manufacturing partner.

USFDA Inspection and Form 483 Observations

The manufacturing pause affects Lanreotide production at Pharmathen International S.A.'s Rodopi facility in Greece, after the USFDA flagged issues during an inspection held between November 10 and 21, 2025. The inspection resulted in nine Form 483 observations, with a redacted version of the report made public on January 7, 2026, sparking media scrutiny and further volatility in Cipla's stock.

US Market Impact and Product 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. Pharmathen operates as Cipla's contract manufacturer and serves as the exclusive supplier of Lanreotide to Cipla USA Inc. The US market holds strategic importance for Cipla, contributing 27.00% to the company's topline with record sales of $934.00 million.

Stock Performance and Technical Analysis

From a valuation perspective, Cipla's stock is trading at a price-to-earnings ratio of 20.59, while its price-to-book ratio stands at 3.58. Technical indicators suggest the stock is under pressure, with the 14-day Relative Strength Index at 32.00, indicating the stock is nearing oversold levels. Additionally, Cipla is trading below all eight of its key Simple Moving Averages, underscoring a bearish technical setup.

Company Response and Remediation Timeline

Following internal evaluation and discussions with Pharmathen, Cipla confirmed that manufacturing of Lanreotide has been temporarily paused to support remediation efforts addressing the USFDA's observations. Until production restarts and receives quality clearance, Lanreotide will remain in limited supply. The company emphasized that it is closely monitoring supply levels and remains committed to restoring stable and reliable availability of the drug at the earliest, with re-supply expected to resume in the first half of FY27.

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.