Chairman and Managing Director of Morepen Laboratories Ltd., Mr. Sushil Suri, stated that an impeccable clean record with regulators and a past hattrick of Nil 483 inspections paved the way for the recent Rs. 825 crore global mandate, noting that this latest successful inspection will further drive engagements of similar scale in the future. Mr. Suri further added that global pharmaceutical companies considering long-term manufacturing partnerships do not take quality assurances at face value, as they look for strong systems, documentation, and the consistency which these events substantiate.
Executive Director and CEO (API) of Morepen Laboratories Limited, Mr. Sanjay Suri, claimed the consistent track record of NIL 483 inspections is a testament to the strength of quality systems and the team’s discipline in adhering to the highest global regulatory standards. He emphasized that this strengthens Morepen’s positioning in highly regulated markets by enhancing credibility with global regulators, customers, and partners, thus facilitating long-term supply contracts across the globe while ensuring the global orders pipeline grows stronger.
Morepen Labs is consistently imbibing robust quality management systems, strong data integrity practices, automation, digitization, and a deep-rooted culture of regulatory compliance in all manufacturing operations, supported by significant investments in these key areas over several years. The company has aligned its operations with evolving global standards, including current ICH and CFR (Part-21) guidelines, to ensure high levels of product quality, safety, and efficacy. Furthermore, the focus on digitalization enhances traceability, transparency, and operational efficiency across manufacturing and quality processes.
As an outcome of these initiatives, Morepen Labs continues to be a preferred partner for global pharmaceutical companies, catering to regulated markets across the US, Europe, and other geographies. Supported by regular and rigorous customer audits, the company exports Active Pharmaceutical Ingredients (APIs) 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, Morepen is strategically expanding into the CDMO space, leveraging its regulatory track record, infrastructure, and technical expertise.
Morepen Laboratories Ltd. is a vertically integrated, innovation-led pharmaceutical and healthcare company delivering high-quality APIs and expanding into branded generics, medical devices, and consumer wellness products to over 90 countries worldwide. With 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 and regulatory approvals from the USFDA, WHO, and EU bodies, the company remains committed to making quality healthcare accessible, affordable, and future-ready. As a leading pharmaceutical company with world-class manufacturing facilities, Morepen continues to focus on innovation, quality, and compliance to serve customers across regulated and emerging markets.
About The Author
Comment List