Morepen Laboratories clears fourth USFDA inspection at Masulkhana facility with NIL 483

Morepen Laboratories announced that it has cleared its fourth consecutive inspection by the United States Food and Drug Administration at its Masulkhana facility with zero observations and no Form 483 issued.

The company stated that the milestone follows a multi-year contract development and manufacturing organisation mandate valued at approximately Rs 825 crore (USD 91 million) from a global pharmaceutical company.

Sushil Suri, Chairman and Managing Director, Morepen Laboratories Ltd., said, “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.”

He 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.”

Sanjay Suri, Executive Director and CEO (API), Morepen Laboratories Limited, said, “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.”

The company stated that it has invested in quality management systems, data integrity practices, automation and digitalisation across manufacturing operations. It added that its processes are aligned with global standards including ICH and CFR Part 21 guidelines.

Morepen stated that it supplies to regulated markets including the United States and Europe and exports active pharmaceutical ingredients to over 80 countries, with annual exports exceeding Rs 670 crore. The company stated that it holds a position in six active pharmaceutical ingredients and is expanding into the contract development and manufacturing organisation segment.

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