The Indian pharmaceutical sector witnessed significant developments as major companies announced production updates, regulatory approvals, and fundraising activities that will impact their operations and growth trajectories.

Cipla Halts Key Drug Production

Cipla Ltd announced on Thursday that production of Lanreotide injection, one of its key pharmaceutical products, will be temporarily paused due to operational challenges at its supply partner's facility. The disruption stems from ongoing remediation activities at Pharmathen International S.A.'s manufacturing plant located in Rodopi, Greece.

Lanreotide injection serves as a critical treatment option for hormone-related disorders and is also utilized in cancer tumour treatments. The company stated that re-supply of Lanreotide to the market is expected to resume in the first half of the financial year 2026-27. Until manufacturing operations restart, the product will remain in limited supply, subject to quality clearance requirements.

Zydus Secures FDA Approval for Blood Disorder Treatment

Zydus Lifesciences Ltd achieved a significant regulatory milestone by securing final approval from the US Food and Drug Administration for Eltrombopag Tablets. The approval covers multiple strengths including 12.50 mg, 25.00 mg, 50.00 mg, and 75.00 mg formulations.

The tablets are specifically indicated for treating thrombocytopenia, a condition characterized by low platelet count in specific blood disorders. Production of these tablets will take place at the group's formulation manufacturing facility located at the Special Economic Zone in Ahmedabad.

Biocon Completes Major Fundraising Initiative

Biocon Ltd, the innovation-led global biopharmaceutical company, successfully completed a Qualified Institutions Placement raising ₹4,150.00 crore from eligible qualified institutional buyers. The QIP was priced at ₹368.35 per share and conducted between January 12 and 14.

The QIP attracted strong investor interest from a broad mix of domestic and international participants. The proceeds will be primarily utilized to meet the cash consideration payable to Mylan Inc. (Viatris) for buying out its shareholding in Biocon Biologics Limited, including repayment of debt availed in this regard.

These developments highlight the dynamic nature of India's pharmaceutical industry, with companies navigating supply chain challenges while simultaneously pursuing growth opportunities through regulatory approvals and strategic financial initiatives.

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.