Morepen Laboratories Limited has informed the Exchange regarding a press release dated April 17, 2026, titled "Morepen Secures Fourth Consecutive USFDA Inspection with ZeroObservations (NIL 483)".
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Morepen Laboratories has received clearance from the USFDA for its API manufacturing facility in Masulkhana, Himachal Pradesh, with zero observations (NIL Form 483). This marks the fourth consecutive NIL 483 inspection over the past eight years, demonstrating consistent compliance with global regulatory standards. The company exports APIs to over 80 countries and serves regulated markets including the US and Europe. Executive Director Sanjay Suri stated this achievement enhances credibility with global regulators, customers, and partners, and paves the way for long-term supply contracts. Morepen is also expanding into the Contract Development and Manufacturing Organization (CDMO) space leveraging its regulatory track record.
A successful USFDA inspection with no observations is positive for the company's reputation in regulated markets and may strengthen its ability to secure long-term supply contracts from global pharmaceutical companies.