Marksans Pharma's Goa facility clears US FDA inspection with zero observations

Marksans Pharma Limited reported today that its second manufacturing facility, located at Plot No. A-1, Phase 1-A, Verna Industrial Estate, Verna, Goa, India, underwent a current Good Manufacturing Practice (cGMP) inspection by the US FDA. The inspection was conducted from November 3, 2025, to November 7, 2025, and concluded with zero Form 483 observations, indicating full compliance with regulatory standards.

Mark Saldanha, managing director of Marksans Pharma, commented that the successful inspection is a "testament to our ongoing commitment to product quality and regulatory compliance." This positive result is significant for the company, which markets generic pharmaceutical formulations in global markets.

Marksans Pharma Limited, headquartered in Mumbai, India, is engaged in research, manufacturing, and marketing. Its manufacturing facilities in India, USA, and UK are approved by various leading regulatory agencies, including the USFDA, UKMHRA, and Australian TGA. The company's product portfolio spans therapeutic segments such as CVS, CNS, anti-diabetic, pain management, gastroenterological, and anti-allergies.