Huiju Pharmaceuticals Reaffirms Global Compliance with Successful PMDA Certification and Multiple International GMP Approvals Within a Year

Recently, Haimen Wisdom Pharmaceutical Co., Ltd. received the "GMP Inspection Report" issued by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) regarding the company’s first generic active pharmaceutical ingredient (API), Aprepitant, in Japan, confirming that Haimen Wisdom Pharmaceutical has once again passed PMDA certification.

Haimen Wisdom Pharmaceutical has successfully passed GMP inspections conducted by multiple official agencies several times over the past year. It has passed U.S. Food and Drug Administration (FDA) inspections twice on the first attempt, China National Medical Products Administration (NMPA) inspections three times, Japan Pharmaceuticals and Medical Devices Agency (PMDA) inspection once, new veterinary drug GMP inspections by China’s Ministry of Agriculture and Rural Affairs (MARA) twice, and an innovative drug inspection by South Korea’s Ministry of Food and Drug Safety (MFDS) once. To date, Haimen Wisdom Pharmaceutical has repeatedly passed cGMP inspections by China’s NMPA, the U.S. FDA, the European Directorate for the Quality of Medicines & HealthCare (EDQM), Japan’s PMDA, South Korea’s MFDS, and China’s MARA, laying a solid foundation for the company’s rapid growth in recent years and its future development.

WISDOM PHARMACEUTICAL CO.,LTD. was established in 2000, specializing in process research, scale-up, and industrialized production of high-end active pharmaceutical ingredients (APIs). Leveraging a comprehensive R&D, quality study, and domestic and international regulatory registration system, as well as a robust quality management system built by its team of over 400 professionals in pharmaceutical R&D and scale-up, and equipped with world-class analytical testing facilities and cGMP-compliant production and analysis platforms, the company provides global pharmaceutical enterprises with an efficient service platform (CDMO) for R&D, scale-up, and domestic and international regulatory submissions.

The company has established long-term partnerships with dozens of innovative drug and generic drug companies both domestically and internationally. Leveraging its robust R&D capabilities and translation capacity, WISDOM PHARMACEUTICAL CO.,LTD. has undertaken CDMO services and MAH business for dozens of innovative drugs in clinical development stages (with several successfully launched in recent years). Meanwhile, it has collaborated with leading domestic and international generic drug manufacturers to develop dozens of specialized generic drugs, and has completed regulatory filings for the active pharmaceutical ingredients (APIs) of nearly 30 projects in China, the United States, Europe, Japan, and South Korea.

Mr. Zou Ping, General Manager of WISDOM PHARMACEUTICAL CO.,LTD., stated that although the company has successfully passed on-site inspections by China’s NMPA, the U.S. FDA, the European EDQM, Japan’s PMDA, and South Korea’s KFDA multiple times in succession, it will continue to optimize and improve its existing EHS, R&D, production, and quality management systems. This commitment ensures that WISDOM PHARMACEUTICAL can serve its partners with greater efficiency and higher quality over the long term, achieving a win-win outcome for employees and shareholders while continuously realizing the company’s and its team’s value and mission in both domestic and international pharmaceutical markets.