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Good News: "I" Status Registration for Cartridge Vial Assembly

Recently, the cartridge‑based assembly submitted by Kaisheng Junheng (Bengbu) Co., Ltd. has completed registration update on the National Medical Products Administration (NMPA) Pharmaceutical Packaging Material Registration Platform, with the registration status marked as “I”, Registration No.: B20260000104, and update date: May 08, 2026.

This achievement could not have been realized without the careful guidance, strategic oversight and resource support from the company’s leadership at all levels. It also embodies the unremitting efforts and hard‑won dedication of the Prefilled Syringe & Cartridge Division in technical breakthroughs, process refinement and registration promotion. The successful approval of this registration status indicates that the technical documentation, manufacturing processes and quality control system for Kaisheng Junheng’s cartridge‑based assemblies have passed compliance review by the national pharmaceutical regulatory authority and meet the requirements for pharmaceutical packaging material registration. It lays a critical foundation for subsequent correlative review and approval with pharmaceutical preparation enterprises and commercial‑scale application.

As core pharmaceutical packaging for high‑end injectables and biological preparations, cartridge‑based assemblies are subject to stringent industry standards for glass material, forming precision, sealing compatibility and chemical resistance. Drawing on mature pharmaceutical glass manufacturing technologies and a full‑process quality control system, Kaisheng Junheng implements full‑chain compliance management covering raw material control, forming processes and finished‑product inspection, ensuring that key performance indicators including water resistance, sealing performance and dimensional accuracy reach internationally advanced levels. At present, the company is capable of producing cartridge‑based assemblies in four specifications: 1.5 ml, 1.8 ml, 3.0 ml and 5.0 ml, stably matching corresponding application scenarios. Meanwhile, R&D of dual‑chamber cartridges is steadily advancing.

Acquisition of the “I” registration status for pharmaceutical packaging materials constitutes full recognition of the company’s product compliance and technical strength, and further enriches Kaisheng Junheng’s product portfolio in the high‑end pharmaceutical glass packaging sector. Going forward, the company will continue to advance process optimization and quality improvement, serve domestic and international pharmaceutical enterprises with higher‑quality products, and contribute to the high‑quality development of China’s high‑end domestic pharmaceutical packaging material industry.