USFDA issues EIR for Marksans Pharma Goa facility
Mumbai: Marksans Pharma has announced that the US Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) for the manufacturing facility of the Company located at Plot No. L-82 & L-83, Verna Industrial estate, Verna, Goa.
The inspection has now been successfully closed by the USFDA. USFDA has determined that the inspection classification of this facility is “Voluntary Action Indicated” (VAI). VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
Read also: Marksans Pharma arm gets UK MHRA marketing authorization for oral emergency contraceptive pill
The USFDA had inspected the facility from 9th April 2024 to 17th April 2024.
Read also: Marksans Pharma gets 5 inspectional observations from USFDA for Goa facility
Marksans Pharma Limited 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. The company’s product portfolio spreads over major therapeutic
segments of CVS, CNS, Anti-diabetic, Pain Management, Upper respiratory and
Gastroenterological. The company is marketing these products globally.
