PRESS RELEASE
Global Regulatory Partners Secures Groundbreaking DMF Approval in China for a New Pharmaceutical - Grade Nitroglycerin Formulation in China
Global Regulatory Partners (GRP) is excited to share the successful approval of its Drug Master File (DMF) for new pharmaceutical formulation of Nitroglycerin by China’s National Medical Products Administration (NMPA), granted on July 8, 2025. This regulatory milestone represents the first authorization in China for the new pharmaceutical nitroglycerin formulation free of ethanol—setting a new standard in patient safety and enhancing the reliability of the pharmaceutical supply chain.
This achievement underscores GRP’s continued commitment to regulatory excellence and innovation, helping clients navigate complex markets and bring safer, high-quality therapies to patients worldwide.
Acting as the local representative in China for an American leading manufacturer of pharmaceutical-grade nitroglycerin, GRP China expertly guided the complex four-year registration journey through pandemic disruptions, evolving technical requirements, and national testing procedures.
The new formulation, which substitutes ethanol with propylene glycol, eliminates key explosive and flammable risks found in traditional nitroglycerin products—offering a safer solution for the treatment of angina and cardiac emergencies.
GRP’s Key Milestones:
- Application Submission: September 2021
- Local Testing Report: November 2024
- Final Approval: July 2025
GRP’s strategic coordination with the National Institutes for Food and Drug Control (NIFDC) and Shanghai laboratories, along with direct engagement with the Center for Drug Evaluation (CDE), ensured the successful clearance of this high-risk API.
About Global Regulatory Partners Group
Global Regulatory Partners (GRP) is a trusted global consultancy serving the life sciences sector with a comprehensive suite of services, including regulatory affairs, pharmacovigilance, clinical development strategy, and market access support. With established local affiliates in China, South Korea, Japan, Mexico, and Brazil, GRP ensures clients benefit from both global expertise and in-country compliance across key markets in the pharmaceutical, biotech, and medical device industries.
Empowering Life-Science Growth Across Borders
GRP Group envisions a world where life-science companies, from emerging startups to global enterprises, can seamlessly enter and thrive in strategic international markets. By leveraging GRP’s robust infrastructure, expertise, and regulatory licenses, we aim to reduce barriers to market entry while minimizing risk and upfront investment.
Through innovation, collaboration, and tailored market solutions, we empower companies to focus on their core mission of advancing healthcare, while we pave their way to success in some of the world’s most critical markets.