Morepen Laboratories Secures Fourth Consecutive NIL 483 USFDA Inspection at Masulkhana Facility

Morepen Laboratories Secures Fourth Consecutive NIL 483 USFDA Inspection at Masulkhana Facility​

Morepen Laboratories Limited announced the successful completion of a United States Food and Drug Administration (USFDA) inspection at its Masulakhana facility in Himachal Pradesh. The inspection, conducted on April 17, 2026, resulted in the facility being cleared with zero adverse observations (NIL Form 483).

This achievement marks the company's fourth consecutive NIL 483 inspection over the past eight years, reinforcing Morepen's commitment to global quality and regulatory standards.

Sanjay Suri, Executive Director of Morepen Laboratories Limited, stated that the consistent record of NIL 483 inspections is a testament to the strength of the company's quality systems and the team's adherence to the highest global standards. He noted that this achievement enhances the company's credibility with global regulators, customers, and partners, thereby paving the way for long term supply contracts.

The successful inspection outcome highlights Morepen's robust quality management systems, strong data integrity practices, and deep-rooted culture of regulatory compliance. The company consistently aligns its operations with evolving global standards, including current ICH and CFR (Part-21) guidelines, ensuring high levels of product quality, safety, and efficacy.

Enhancing Global Market Position and Capabilities​

Morepen Laboratories Ltd. continues to maintain a strong position in regulated markets across the US, Europe, and other geographies. The company exports Active Pharmaceutical Ingredients (APIs) to over 80 countries, a volume supported by regular and rigorous customer audits.

Strategically, Morepen is a recognized market leader in six key Active Pharmaceutical Ingredients (APIs). Building on this foundation, the company is expanding into the Contract Development and Manufacturing Organization (CDMO) space, aiming to leverage its regulatory track record, infrastructure, and technical expertise.

The company has also made significant investments in digital systems, automation, and data integrity frameworks. This focus on digitalization enhances traceability, transparency, and operational efficiency across its manufacturing and quality processes, further bolstering its ability to serve global supply chains.

MOREPENLAB Stock Price Movement​

Shares of Morepen Laboratories Limited are edging higher to ₹41.76 as of 2:22 PM today, rallying 1.43% in live trading. The stock has traded within a range of ₹41.00 to ₹42.01, supported by a robust volume of 2.22 million shares.

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