Company sets a benchmark again in pharmaceutical excellence reinforcing its global leadership in quality and regulatory compliance
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.
Corporate Comm India (CCI Newswire)
