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USFDA inspection: Morepen Labs Gets NIL 483:

Morepen Laboratories Limited (NSE: MOREPENLAB; BSE: 500288) has announced the successful completion of a USFDA (United States Food and Drug Administration) inspection at its Masulakhanna (Himachal) facility, with Zero adverse observations (No Form 483 issued by the drug regulator). This marks the Fourth consecutive NIL 483 USFDA inspection for Morepen over the past eight years.

The milestone arrives at a defining moment for Morepen Labs just weeks after the company disclosed a multi-year CDMO mandate worth approximately Rs. 825 crore (USD 91 million) from a leading global pharma major. “Impeccable clean record with the regulators and a past hattrick of Nil 483 inspections had paved the way for the recent Rs. 825 crore global mandate. The last concluded successful inspection will further drive engagements of similar scale in future,” Mr. Sushil Suri, Chairman and Managing Director, Morepen Laboratories Ltd., said.

Mr. Suri further added,“Global pharmaceutical companies considering long-term manufacturing partnerships do not take quality assurances at face value, they look for strong systems, documentation and more importantly the consistency which these events substantiate.”

“Our consistent track record of NIL 483 inspections is a testament to the strength of our quality systems and our team’s discipline in adhering to the highest global regulatory standards. It strengthens Morepen’s positioning in highly regulated markets by enhancing company’s credibility with global regulators, customers, and partners thus facilitating for long term supply contracts across the globe. Our global orders pipeline only gets stronger from here,” Mr. Sanjay Suri, Executive Director and CEO (API) Morepen Laboratories Limited, claimed.

Morepen Labs is consistently imbibing robust quality management systems, strong data integrity practices, automation, digitization and deep-rooted culture of regulatory compliance in all its manufacturing operations. A large amount of investment has been done by the company in these key areas over the past several years. The Company has consistently aligned its operations with evolving global standards, including current ICH and CFR (Part-21) guidelines, ensuring high levels of product quality, safety, and efficacy as required by global drug regulators. The Company’s focus on digitalization enhances traceability, transparency, and operational efficiency across its manufacturing and quality processes.

As an outcome of these initiatives, Morepen Labs continues to be a preferred partner for global pharmaceutical companies, successfully catering to regulated markets across the US, Europe, and other geographies. Supported by regular and rigorous customer audits, the company exports APIs (Active Pharmaceutical Ingredients) to over 80 countries, aggregating to more than Rs. 670 crores annually. The company is a recognized market leader in six key APIs, with a strong presence in global supply chains. Building on this foundation, the Company is now strategically expanding into the CDMO space, aiming to leverage its regulatory track record, infrastructure, and technical expertise.

About Morepen Laboratories Limited

Morepen Laboratories Ltd. is a vertically integrated, innovation-led pharmaceutical and healthcare company delivering high-quality APIs, having expanded into CDMO space, branded generics, medical devices, and consumer wellness products to over 90 countries worldwide. With a high installed API capacities, a 14 million-strong glucometer user base, and a rapidly expanding digital footprint, Morepen stands at the forefront of India’s health-tech evolution. Backed by decades of trust, regulatory approvals from USFDA, WHO, and EU bodies, and a passion for innovation, Morepen is committed to making quality healthcare accessible, affordable, and future-ready.

Morepen Laboratories Limited is a leading pharmaceutical company with a strong presence in APIs, formulations, and home health products. With world-class manufacturing facilities and a global footprint, the Company continues to focus on innovation, quality, and compliance to serve customers across regulated and emerging markets.

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