Recently, Hengrui Pharmaceuticals has received the GMP certificate issued by Japan Pharmaceuticals and Medical Devices Agency (PMDA) for its preparation production site located at No. 38, Huanghe Road, Lianyungang, and the company's Dexmedetomidine Hydrochloride Injection has successfully passed the GMP compliance inspection by PMDA. This is the company's quality management system again recognized by international authoritative institutions after the API dexmedetomidine hydrochloride PMDA site inspection was passed, which is conducive to the company to further strengthen the internationalization strategy and enhance the competitiveness in the global market.

Japanese GMP certification is one of the authoritative certifications in the field of international drug production, and the inspection is characterized by rigor, meticulousness and attention to details.2023 In September, two qualification inspectors of Japan PMDA conducted a GMP on-site inspection for several days on Hengrui Pharmaceuticals' Dexmedetomidine Hydrochloride Injection production line at the preparation production site located at No. 38 Huanghe Road, Lianyungang. The scope of the inspection covered all aspects of the company's organization and personnel, production system, facilities and equipment system, quality management system as well as computerized system management and QC laboratory. After rigorous examination, the inspector highly praised the company's perfect quality management system and sound quality management system, and formally issued the GMP certification.

Dexmedetomidine Hydrochloride Injection is used for preoperative sedation/anti-anxiety, and the company's production line strictly follows the international GMP standard. The GMP certification by Japan PMDA not only means that the company has maintained the international leading level of quality control capability in the production of injectable drugs, but also highlights the company's firm determination and unremitting efforts in its internationalization strategy.

As an innovative international pharmaceutical enterprise, Hengrui Pharmaceuticals has always firmly implemented the quality policy of "integrity-based, quality first", constantly refined its quality management mode against the international first-class standards, and established an internationally standardized production workshop with first-class production equipment. By the end of 2023, the company's products have entered more than 40 countries, and obtained nearly 20 registration approvals in Europe, the United States and Japan, including injections, oral preparations and inhalation anesthetics. 2011, the company's anti-tumor drug irinotecan injection was approved to be listed in the U.S., and the company became the first national pharmaceutical company whose injections were approved to be listed in the U.S. In 2017, the company's docetaxel injection was approved to be listed in the U.S. and designated by the U.S. FDA as the most suitable drug for the treatment of cancer and other diseases. In 2017, the company's docetaxel injection was approved to be listed in the U.S. and designated as a control standard preparation (RS) by the U.S. FDA.2024 Since then, the company's immunosuppressant tacrolimus extended-release capsules have been approved to be listed in the U.S. for sale, which is the first generic of the species approved by the U.S. FDA for listing in the U.S.; the company's bupivacaine liposome injection has been approved to be listed in the U.S. and is the first generic of the species to be listed on the market globally. At present, the company is also continuing to accelerate the development of global markets and focus on emerging markets.

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