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USFDA concludes inspection at Marksans Pharma Goa facility with zero Form 483 observation

Mumbai: Marksans Pharma has announced that the U.S. Food and Drug Administration (USFDA) has concluded an inspection at the 2nd manufacturing facility at Verna, Goa with Zero Form 483 observation.

The Good Manufacturing Practice (cGMP) inspection was held from 3rd November 2025 to 7th November 2025.

“This is to inform you that a current Good Manufacturing Practice (cGMP) inspection was conducted by the US FDA at the 2nd manufacturing facility of the Company located at Plot No. A-1, Phase 1-A, Verna Industrial Estate, Verna, Goa, India from 3rd November 2025 to 7th November 2025,” Marksans stated in a BSE filing.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Mark Saldanha, Managing Director said, “The successful outcome of the cGMP inspection by the US FDA is a testament to our ongoing commitment to product quality and regulatory compliance.”

The company headquartered at Mumbai, India is engaged in Research, Manufacturing & Marketing of generic pharmaceutical formulation in the global markets. The company’s manufacturing facilities located in India, USA and UK are approved by several leading regulatory agencies including USFDA, UKMHRA and Australian TGA. Marksans’s product portfolio spreads over major therapeutic segments of CVS, CNS, Anti-diabetic, Pain Management, Gastroenterological and Antiallergies. The company is marketing these products globally.

Read also: Marksans Pharma UK arm gets marketing nod for Exemestane 25mg film-coated tablets

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