USFDA issues positive EIR to Lupin Limited at Gujarat

This signifies that the USFDA found no observations regarding compliance or quality standards.

July 16, 2024

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Last Updated on December 31, 2024 by The Health Master

USFDA

Lupin Limited, a leading global pharmaceutical company, has secured a significant win with the U.S. Food and Drug Administration (USFDA) granting its Dabhasa manufacturing facility (Gujarat, India) a clean bill of health.

This achievement underscores Lupin’s unwavering commitment to delivering high-quality, affordable generic drugs and Active Pharmaceutical Ingredients (APIs) to patients worldwide.

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Flawless Inspection, Flawless Results

The USFDA conducted a thorough inspection of the Dabhasa facility from April 8th to 12th, 2024.

The inspection culminated in an Establishment Inspection Report (EIR) with the coveted classification of “No Action Indicated” (NAI).

This signifies that the USFDA found no observations regarding compliance or quality standards.

Lupin Manufacturing Solutions

The Dabhasa facility falls under the umbrella of Lupin Manufacturing Solutions (LMS).

LMS is a dedicated division of Lupin that focuses on the development, manufacturing, and commercialization of APIs while simultaneously building a robust Contract Development and Manufacturing Operations (CDMO) business.

This strategic move allows Lupin to not only produce its own high-quality medications but also partner with other pharmaceutical companies to bring innovative drugs to market.

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Lupin’s unwavering commitment to quality

Nilesh Gupta, Managing Director of Lupin, expressed his satisfaction with the EIR, highlighting the company’s relentless pursuit of the highest quality and compliance standards across all its operations.
Investment in Excellence: Lupin dedicates a significant portion of its revenue (7.8% in FY24) to research and development (R&D), ensuring a steady pipeline of innovative and effective medications.
Global Reach: Lupin is a transnational pharmaceutical leader headquartered in Mumbai, India. It has a presence in over 100 markets across the globe, catering to patients in the U.S., India, South Africa, Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East.
Diverse Portfolio: The company offers a vast array of branded and generic formulations, biotechnology products, and APIs. They specialize in crucial therapeutic areas like cardiovascular, anti-diabetic, and respiratory health while maintaining a strong presence in anti-infective, gastrointestinal (GI), central nervous system (CNS), and women’s health segments.
Manufacturing Prowess: Lupin boasts an impressive infrastructure with 15 state-of-the-art manufacturing facilities strategically located across the globe, along with 7 dedicated research centers.

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