Marksans Pharma’s Goa Facility Passes US FDA Inspection
Filing Summary
Marksans Pharma Ltd announced that the US FDA conducted a current Good Manufacturing Practice (cGMP) inspection at its second manufacturing facility in Verna, Goa. The inspection took place from November 3 to November 7, 2025, and concluded with zero Form 483 observations. This indicates compliance with regulatory standards. Marksans Pharma is involved in the research, manufacturing, and marketing of generic pharmaceutical formulations globally, with facilities approved by major regulatory agencies.
Marksans Pharma Ltd reported that the US FDA conducted a current Good Manufacturing Practice (cGMP) inspection at its second manufacturing facility located at Plot No. A-1, Phase 1-A, Verna Industrial Estate, Verna, Goa, India. The inspection was carried out from November 3 to November 7, 2025.
The inspection concluded with zero Form 483 observations, indicating that the facility met the required regulatory standards without any noted deficiencies. The absence of Form 483 observations suggests compliance with the US FDA’s cGMP requirements.
Marksans Pharma is engaged in the research, manufacturing, and marketing of generic pharmaceutical formulations in global markets. The company’s manufacturing facilities in India, the USA, and the UK are approved by several leading regulatory agencies, including the US FDA, UKMHRA, and Australian TGA. Marksans Pharma’s product portfolio covers major therapeutic segments such as cardiovascular, central nervous system, anti-diabetic, pain management, gastroenterological, and anti-allergies. The company markets these products globally.