Atom High-Tech Adds New Radiopharmaceutical Production Base in Changchun

The Jilin Provincial Medical Products Administration issued a public notice on August 21 stating that, in accordance with the Drug Administration Law of the People's Republic of China, the Regulations on the Administration of Radiopharmaceuticals, the Measures for the Supervision and Administration of Drug Production, and other relevant provisions, following on-site inspection and review approval, it intends to issue the Radiopharmaceutical Production License to Changchun Atom High-Tech Pharmaceutical Co., Ltd. The public notice period is 5 working days, subject to public supervision.

The notice information shows that the registered address of Changchun Atom High-Tech Pharmaceutical Co., Ltd. is located at No. 770 Shengye Road, Beihu Science and Technology Development Zone, Changchun City, Jilin Province, and the proposed production address for the license is consistent with the registered address. The proposed production scope for this license is small-volume injections for in vivo radiopharmaceuticals, involving products such as Sodium Pertechnetate [99mTc] Injection, Technetium [99mTc] Methylenediphosphonate Injection, Technetium [99mTc] Methoxyisonitrile Injection, Technetium [99mTc] Pentetate Injection, Technetium [99mTc] Ethyl Cysteinate Dimer Injection, and Technetium [99mTc] Etifenin Injection.

According to available information, Changchun Atom High-Tech Pharmaceutical Co., Ltd. was established in 2016 and is an affiliate of Atom High-Tech. The company obtained the Radiation Safety License in September 2024. This public notice of the proposed issuance of the Radiopharmaceutical Production License indicates that it has entered a new procedural stage in the qualification process for radiopharmaceutical production.

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