This provides core access qualification for further expanding the product into the Middle East and other PIC/S member markets.
Nanchang, Jiangxi, ChinaJune 18, 2026 /PRNewswire/ — On June 18, the Jemincare Group announced that its subsidiary, Jiangxi Aisite Pharmaceutical Co., Ltd., has officially obtained the GMP certification certificate issued by the Saudi Food and Drug Authority (SFDA) for its Amphotericin B Liposome for Injection. This milestone paves the way for the product’s entry into the Saudi market and provides core access qualification for further expanding into the Middle East and other PIC/S member markets.
Jemincare’s Amphotericin B Liposome for Injection passes Saudi official GMP audit
The Saudi Food and Drug Authority (SFDA) is a full member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). During the audit, the SFDA audit team conducted a rigorous inspection of the freeze-dried powder injection production line and the Amphotericin B Liposome for Injection product. Aisite Pharmaceutical’s comprehensive quality control system, solid professional expertise, efficient collaboration capabilities, and internationally aligned technical service capabilities received high recognition and full affirmation from the Saudi audit experts. Following the acquisition of a Turkish GMP certificate in April of this year, Jemincare has passed another foreign official audit within two months. This achievement not only confirms that the company’s quality management system has fully aligned with international standards but also drives the steady improvement of the international competitiveness of its high-end formulations.
In recent years, the Jemincare Group has been deeply committed to internationalization, establishing multiple intelligent production bases in Jiangxi, Jiangsu, Zhejiang, and other regions that meet FDA and EU standards, and fully implementing internationally advanced management concepts such as QbD (Quality by Design) and TQM (Total Quality Management). Currently, the group’s formulations and active pharmaceutical ingredients are exported to over 50 countries and regions worldwide. In the field of innovative drugs, Jemincare has successfully licensed four innovative drugs to internationally renowned companies, including Genentech, a member of the Roche Group, and RAPT Therapeutics in the United States.
Notably, Jemincare is upgrading from “product going global” to “platform going global.” The group has launched a “Global Partner Program,” aimed at opening up the company’s overseas market networks, clinical development, and international access resources to collaborate with domestic peers in exploring international markets. Through a development path of “comprehensive planning + selective overseas expansion + global coverage,” Jemincare is actively promoting the industry’s “collective going global.” At the same time, the group introduces international innovative therapies through a “two-way cooperation” model, enabling domestic patients to benefit simultaneously from global pharmaceutical innovations. While adhering to “going global,” Jemincare is also actively introducing internationally leading drugs into the Chinese market to meet the growing clinical needs in China.