Marksans Pharma gets 2 USFDA observations for Goa facility
Mumbai: Marksans Pharma has announced that the United State Food and Drug Administration (USFDA) has completed a Post-marketing Adverse Drug Experience (PADE) inspection. The inspection closed with two observations.
The inspection was conducted at its Goa, Verna manufacturing facility from 31st July, 2023 to 4th August, 2023.
The inspection included comprehensive scrutiny of practices and procedures for reporting of adverse events of Marksans' marketed products.
"We will submit corrective and preventive action plan (CAPA) to the US FDA in the stipulated time frame," the company stated in a BSE filing.
Read also: Marksans Pharma concludes acquisition of Tevapharm India's Goa manufacturing site
Marksans Pharma Ltd headquartered in Mumbai, India is engaged in the Research, Manufacturing & Marketing of generic pharmaceutical formulations in the global markets. The company's manufacturing facilities are approved by several leading regulatory agencies including USFDA, UKMHRA, and Australian TGA. The company's robust product portfolio spreads over major therapeutic segments of CVS, CNS, Antidiabetic, Pain Management, Gastroenterological, and Anti-allergies. The company is marketing these products globally.
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