On March 9, 2026, a high‑level delegation from the U.S. Pharmacopeia (USP) visited Milestone Pharma. The delegation was led by Amanda Cowley, USP SVP and Chief Growth Officer, and Dr. Cen Guoshan, USP VP and China General Manager. Together with Milestone Pharma’s core team, the two sides engaged in in‑depth strategic discussions on pharmacopeial standards application, tackling complex drug technologies, and future strategic collaboration directions – jointly promoting the harmonized development of global pharmaceutical quality standards.
During the exchange, Mr. Gu Kai, General Manager and Founder of Milestone Pharma, extended a warm welcome to the USP delegation. Core team members including Mr. Zhu Zifeng, Deputy General Manager and Co‑founder, and Dr. Zhang Chuhang, Deputy General Manager, also participated. Both sides presented their respective development strategies and core strengths, and had in‑depth discussions on key technical topics such as nitrosamine impurity research and nanomedicine characterization. Milestone Pharma’s technical capabilities in pharmaceutical quality research and its global compliance expertise were highly recognized by the delegation. Furthermore, preliminary consensus was reached on potential collaboration areas such as nitrosamine impurity research, laying a solid foundation for further cooperation.
After the meeting, accompanied by Milestone Pharma’s core team, the USP delegation toured Milestone Pharma’s Shanghai laboratory, gaining first‑hand insight into the company’s ability to execute USP pharmacopeial methods, its laboratory information management system, and its high‑end analytical platform setup. The delegation fully affirmed Milestone’s professional expertise and technical strength.
As an international provider of drug quality research services, Milestone Pharma is guided by the philosophy “Science drives quality; technology sets the standard.” The company has built a multi‑category, full‑lifecycle quality research platform and has successfully passed numerous international and domestic regulatory audits, including FDA, EU‑QP, and NMPA, serving more than 2,500 clients worldwide. This in‑depth exchange with USP marks a significant step forward for Milestone Pharma in the collaborative development of international pharmaceutical standards.
Headquartered in Nanjing, Milestone Pharma operates nearly 10,000 square meters of CNAS‑accredited laboratories in Nanjing Jiangbei New Area and Shanghai Pudong New Area. An information management system covering the entire R&D process (including DMS, ELN, CDS, etc.) ensures complete and reliable data, traceable processes, and compliant, efficient operations. Milestone Pharma’s six core business systems cover: small molecule chemistry (innovative drugs, generics, APIs, and pharmaceutical excipients); TIDES (peptide drugs, oligonucleotides, and related chemical conjugates); biologics (proteins, antibodies, bioconjugates, and vaccines); nanomedicines and advanced drug delivery systems; advanced therapy medicinal products (ATMP); and drug‑device combinations and packaging systems.
Looking ahead, Milestone Pharma will continue to deepen its collaboration with USP and other international authoritative standards organizations, actively participate in the development and revision of global pharmacopeial standards, and steadily transition from a “standard follower” to a “standard contributor.” With its professional expertise and global vision, Milestone Pharma is committed to enhancing global pharmaceutical quality and driving high‑quality development of the pharmaceutical industry.
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