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NMPA Announcement on Issuing the Pharmaceutical Excipients Annex and Pharmaceutical Packaging Materials Annex of the Good Manufacturing Practice for Drugs (2010 Revision) (No.1, 2025)
2025-06-11
To implement relevant regulations such as the Drug Administration Law of the People's Republic of China, the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, the Provisions for Drug Registration, and the Provisions for Drug Manufacturing Supervision and Administration, and to supervise and guide the standardized production of pharmaceutical excipients and pharmaceutical packaging materials manufacturers, the National Medical Products Administration has organized the formulation of the Pharmaceutical Excipients Annex and Pharmaceutical Packaging Materials Annex.
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Zolbetuximab for Injection Approved for Marketing by China NMPA
2025-06-11
Recently, the Zolbetuximab for Injection (trade name: 威络益/VYLOY) of Astellas Pharma Europe B.V. is approved for marketing by China NMPA.
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Tagitanlimab Injection Approved for Marketing by China NMPA
2025-06-11
Recently, the Tagoliticimab Injection (trade name: 科泰莱) of Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. is approved for marketing by China NMPA.
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Amimestrocel Injection Approved with Conditions for Marketing by China NMPA
2025-06-11
Recently, the Amimestrocel Injection (trade name: 睿铂生) of Platinumlife Biotechnology (Beijing) Co., Ltd. is approved with conditions through the priority review and approval procedure by China NMPA.
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Innovative TCM Xiao’er Huangjin Zhike Granules Approved for Marketing by China NMPA
2025-06-11
Recently, the Class 1.1 innovative traditional Chinese medicine (TCM) Xiao' er Huangjin Zhike Granules of Beijing Dongfang Yunjia Pharmaceutical Co., Ltd. is approved for marketing through the priority review and approval procedure by China NMPA.
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Recaticimab for Injection Approved for Marketing by China NMPA
2025-06-11
Recently, the Recaticimab for Injection (trade name: 艾心安) of Guangdong Hengrui Pharmaceutical Co., Ltd. is approved for marketing by China NMPA.
