We are delighted to share exciting news from our client, Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd.: sitagliptin and metformin hydrochloride extended-release tablets, supported by Milestone Pharma’s technical expertise, have received tentative approval from the U.S. FDA.
Milestone Pharma was honored to be responsible for the project’s critical nitrosamine impurity studies, providing important support for its successful advancement.
Project Highlights
Throughout the project, Milestone Pharma leveraged its advanced nitrosamine genotoxic impurity research platform, strictly adhered to GMP standards, and met the requirements of ICH Q2 and USP <1469>. The company provided comprehensive nitrosamine impurity research services, including risk assessment and analytical method development and validation, fully supporting the product through the U.S. FDA’s stringent review process.
Information on the product is now available on the official FDA website.
The successful tentative approval of Fosun Wanbang’s product, supported by Milestone Pharma, is the result of the close collaboration and complementary strengths of both companies.
Fosun Wanbang has extensive expertise in pharmaceutical R&D and manufacturing. The company has established one of China’s leading R&D and manufacturing bases for genetically engineered drugs and holds an industry-leading position in complex small-molecule generic drugs.
Milestone Pharma, drawing on its professional pharmaceutical quality research services, provided solid assurance for quality control throughout the project.
Looking ahead, Milestone Pharma will continue to uphold its customer-centric service philosophy, continuously enhance its technical capabilities, and provide higher-quality, more efficient services to pharmaceutical companies worldwide.
Once again, we extend our warmest congratulations to Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd. on this important achievement.
Milestone Pharma looks forward to continuing to support more clients with high-quality services as they expand into global markets.
Nitrosamine Impurity Research
The Trace Analysis Team at Milestone Pharma has been conducting nitrosamine impurity research since 2018. The team closely tracks updates to regulations and guidelines issued by major global regulatory and pharmacopeial authorities, including the NMPA, FDA, EMA, and USP.
Drawing on experience from hundreds of successful registration projects and supplementary information responses, the team has helped clients complete nitrosamine studies for multiple markets, including China, the United States, the European Union, the United Kingdom, Japan, Singapore, and South Korea.
To date, the team has developed and validated more than 1,000 analytical methods for nitrosamine studies. Its instruments and methods collectively cover all four analytical techniques recommended in USP <1469>.
Milestone Pharma also maintains an inventory of more than 300 nitrosamine reference standards, including technically challenging standards such as N-nitrosomeglumine, N-nitrosovancomycin, N-nitroso-EDTA-related impurities, and ¹⁵N-labeled impurities.
Building on nine years of technical experience, Milestone Pharma has established an integrated nitrosamine impurity research service platform covering:
Reference standard customizationAnalytical method development and validationRelease testingFalse-positive investigation
Nitrosamine impurity source-tracing analysis
Mechanistic investigation of nitrosamine impurity formationNitrosamine impurity mitigation and elimination studies
Drug product manufacturing process improvement and change implementation
Through this integrated platform, Milestone Pharma provides end-to-end technical support for nitrosamine impurity research, helping pharmaceutical companies manage nitrosamine-related risks and comply with evolving regulatory requirements across global markets.
