Morepen Labs' HP facility clears USFDA inspection with zero observations
Morepen Laboratories Ltd announced its API manufacturing facility in Masulkhana, Himachal Pradesh, successfully cleared a USFDA inspection on April 17, 2026, with zero observations (NIL Form 483). This marks the fourth consecutive NIL 483 inspection for Morepen over the past eight years, reinforcing the company's commitment to global quality and regulatory standards. Executive Director Sanjay Suri stated this achievement enhances credibility with global regulators, customers, and partners, potentially leading to long-term supply contracts. The company's robust quality management systems, strong data integrity practices, and alignment with evolving global standards were highlighted. Morepen exports APIs to over 80 countries and is strategically expanding into the CDMO space.
Key Highlights
- Morepen's Masulkhana API facility cleared USFDA inspection on April 17, 2026.
- The inspection resulted in zero adverse observations (NIL Form 483).
- This is the fourth consecutive NIL 483 inspection for the company in eight years.
- Success reinforces global quality, compliance, and regulatory excellence.
- Enhances credibility and paves the way for long-term supply contracts.