Marksans Pharma’s US Subsidiary Clears USFDA Hurdle: Boosts Global Expansion Plans

Marksans Pharma Ltd. has announced a significant regulatory milestone as its wholly owned US subsidiary, Time-Cap Laboratories Inc., received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its manufacturing facility in Farmingdale, New York. The EIR follows a rigorous current Good Manufacturing Practices (cGMP) inspection conducted from April 16 to April 24, 2025.

 

Key Highlights:

 

Successful USFDA Inspection: The inspection resulted in only one observation on Form 483, with no data integrity issues identified—demonstrating robust compliance with US regulatory standards.

 

Immediate Market Impact: Shares of Marksans Pharma rose by 1.86% to Rs 257 after the announcement, reflecting investor confidence in the company’s regulatory track record and US market prospects.

 

Global Quality Credentials: The EIR reinforces Marksans Pharma’s reputation for maintaining high-quality manufacturing standards. The company’s facilities in India, the US, and the UK are approved by leading global regulators including the USFDA, UKMHRA, and Australia’s TGA.

 

Diverse Product Portfolio: Marksans Pharma continues to expand its global footprint with a broad range of generic formulations across cardiovascular, central nervous system, anti-diabetic, pain management, gastroenterological, and anti-allergy segments.

 

Financial Performance: The company recently reported a 15.7% increase in consolidated net profit and a 26.5% rise in revenue for Q4 FY25, underlining its strong operational momentum.

 

This USFDA clearance not only strengthens Marksans Pharma’s US presence but also underscores its commitment to quality and regulatory compliance as it accelerates growth in regulated markets.

 

Sources: Business Standard, Medical Dialogues, Business Upturn