Morepen Labs Clears USFDA Inspection With Zero Observations at Himachal API Facility
New Delhi: Morepen Laboratories Limited has successfully completed a United States Food and Drug Administration (USFDA) inspection at its API manufacturing facility in Masulkhana, Himachal Pradesh, with zero observations (NIL Form 483), marking its fourth consecutive clean inspection over the past eight years and reinforcing its global compliance and quality standards.
The inspection, concluded on April 17, 2026, resulted in no adverse observations, indicating full compliance with regulatory requirements.
The company formally disclosed the development to stock exchanges including the National Stock Exchange of India and BSE Limited.
Executive Director Sanjay Suri stated that the consistent NIL 483 track record reflects the company’s robust quality framework and enhances its credibility with global regulators, customers, and partners, while also supporting long-term supply contracts.
The inspection outcome also underscores Morepen’s focus on maintaining strong data integrity practices and aligning operations with global guidelines such as ICH and CFR (Part 21), ensuring product safety, quality, and efficacy.
The company continues to serve regulated markets including the US and Europe and exports active pharmaceutical ingredients (APIs) to over 80 countries, supported by regular customer audits and a well-established distribution network.
Morepen has also invested significantly in digital systems, automation, and data integrity frameworks, improving traceability, transparency, and operational efficiency across manufacturing and quality processes.
Recognised as a market leader in six key APIs, the company is now expanding into the Contract Development and Manufacturing Organization (CDMO) space, leveraging its regulatory track record, infrastructure, and technical expertise to drive future growth.
Morepen Laboratories is a vertically integrated, innovation-driven pharmaceutical and healthcare company with a global presence across over 90 countries, offering APIs, branded generics, medical devices, and consumer wellness products, and supported by strong manufacturing capabilities and regulatory approvals from USFDA, WHO, and EU authorities.
The company also maintains a large installed API capacity, a 14 million-strong glucometer user base, and a growing digital footprint, positioning itself at the forefront of India’s health-tech evolution.
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