This highlights Jemincare’s international competitiveness and global quality credibility in the field of advanced formulations.
NanchangMay 29, 2026 /PRNewswire/ — On May 29, Jemincare Group announced that the freeze-dried powder injection production line and its core product, liposomal amphotericin B for injection, at its subsidiary Jiangxi Aisite Pharmaceutical Co., Ltd., successfully passed the GMP compliance inspection by the Turkish Medicines and Medical Devices Agency (TİTCK) and was granted a GMP certificate. This marks another key milestone in the company’s internationalization process, following the certification of multiple group products by international authoritative drug regulatory agencies such as the FDA and Brazil’s ANVISA.
Jemincare’s liposomal amphotericin B for injection passes Turkish official GMP audit
As an important member of PIC/S, Turkey’s GMP certificate is widely recognized in the global pharmaceutical field, providing core market access for products entering Turkey and other PIC/S member countries. The TİTCK audit team conducted a comprehensive, in-depth, and professional review of Aisite Pharmaceutical’s production operations and quality management systems, concluding that the company’s production management and quality control fully comply with EU GMP and PIC/S member country standards. The auditors highly praised the company’s rigorous quality culture, comprehensive lifecycle quality management system, advanced intelligent production facilities, and professional, efficient team execution.
In recent years, Jemincare has continuously deepened its presence in the international market, establishing multiple intelligent production bases that meet FDA and EU standards. The company has fully implemented internationally advanced management concepts such as QbD (Quality by Design) and TQM (Total Quality Management), providing strong quality assurance for product internationalization. Currently, the group’s formulations and active pharmaceutical ingredients are exported to more than 50 countries and regions worldwide, building an extensive international market network and continuously expanding its global footprint. This successful passage of the Turkish PIC/S GMP audit underscores Jemincare’s international competitiveness and global quality credibility in the advanced formulations sector.
Additionally, Jemincare has launched the “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, upgrading from “product going global” to “platform going global.” Through a development path of “comprehensive planning + selective overseas expansion + global coverage,” Jemincare is actively promoting the industry’s “collective going global” approach. At the same time, through a “two-way cooperation” model, the company is introducing international innovative therapies, allowing patients to benefit simultaneously from global pharmaceutical innovation achievements.