Wholly-owned subsidiary Xiantai Pharmaceutical obtains Spanish AEMPS GMP compliance certificate
March 13, 2025
Source: drugdu
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On March 12, North China Pharmaceutical announced that its wholly-owned subsidiary North China Pharmaceutical Group Xiantai Pharmaceutical Co., Ltd. received the "Manufacturer GMP Compliance Certificate" issued by the Spanish Medicines and Medical Devices Agency. The production lines involved in the certificate include procaine penicillin series products, benzathine penicillin series products and amoxicillin (sterile), and the inspection conclusion is in compliance with EU GMP principles. Among them, the inspection of amoxicillin (sterile) is the first drug GMP compliance inspection before it is listed in the EU. Xiantai Company is the only domestic amoxicillin (sterile) manufacturer that has passed EUGMP certification. The acquisition of this certificate will have a positive impact on the sales of amoxicillin (sterile) products to the EU market, but will not have a significant impact on the company's current operating performance.
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