Marksans Pharma Ltd successfully concluded the US FDA’s CGMP inspection at its Goa manufacturing facility with zero observations. This achievement underscores the company’s commitment to compliance, quality manufacturing, and global regulatory standards, enhancing its reputation and strengthening its position in the competitive pharmaceutical export market.
Marksans Pharma Ltd announced the successful completion of the US Food and Drug Administration (FDA) Current Good Manufacturing Practices (CGMP) inspection at its manufacturing facility in Goa. The inspection concluded with zero Form 483 observations, reflecting high compliance with regulatory requirements and quality standards.
Compliance and Quality Assurance
The zero observations status during the CGMP inspection signifies Marksans Pharma’s unwavering focus on maintaining stringent manufacturing processes and quality controls. This achievement assures customers and stakeholders of the company’s dedication to delivering safe and effective pharmaceutical products.
Strategic Importance
Passing the FDA inspection without any adverse findings enhances Marksans Pharma's credibility in the global market, particularly in regulated territories like the United States. It opens avenues for further product approvals and strengthens ongoing export operations.
Future Outlook
Marksans Pharma aims to capitalize on this inspection success by expanding its product portfolio and entering new markets. The company’s adherence to global manufacturing standards positions it favorably for sustained growth and increased market presence..
Sources: Marksans Pharma official release, US FDA, Economic Times, Business Standard