Last Updated on September 30, 2024 by The Health Master
USFDA
Mumbai, India – In a significant development for the Indian pharmaceutical industry, Marksans Pharma has announced the successful completion of a US Food and Drug Administration (USFDA) inspection at its manufacturing facility in Verna, Goa.
The company received an Establishment Inspection Report (EIR) with a classification of “Voluntary Action Indicated” (VAI).
This outcome is considered a positive one as it indicates that while minor issues were identified, they do not warrant regulatory action.
The inspection, which took place from April 9th to April 17th, 2024, was a rigorous evaluation of the facility’s adherence to stringent USFDA guidelines for good manufacturing practices (GMP).
The successful closure of the inspection is a testament to Marksans Pharma’s commitment to quality and compliance.
What Does VAI Mean?
A VAI classification from the USFDA is generally viewed favorably by the industry.
It signifies that while the inspection uncovered some areas for improvement, the observed conditions were not severe enough to necessitate regulatory intervention.
Marksans Pharma is likely to take prompt action to address the identified issues and enhance its manufacturing processes further.
About Marksans Pharma
Headquartered in Mumbai, Marksans Pharma is a leading player in the global pharmaceutical market.
The company is engaged in research, manufacturing, and marketing generic formulations across various therapeutic areas, including:
- Cardiovascular,
- Central nervous system,
- Anti-diabetic,
- Pain management,
- Respiratory, and
- Gastrointestinal disorders.
With manufacturing facilities in India, the USA, and the UK, Marksans Pharma has established a strong global footprint.
Its commitment to quality and compliance is evident in its approvals from regulatory authorities such as the USFDA, UK MHRA, and Australian TGA.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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