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中关村:下属公司生产的盐酸纳曲酮片通过仿制药一致性评价

Core Viewpoint - The company Beijing Huasu Pharmaceutical Co., Ltd. has successfully passed the consistency evaluation of quality and efficacy for its generic drug, "Sodium Naltrexone Tablets" (50mg) [1] Group 1: Product Information - The drug is named Sodium Naltrexone Tablets, with a registered trademark of Noxins [1] - The dosage form is a tablet, with a specification of 50mg [1] - The registration category is classified as a chemical drug, with acceptance number CYHB2450481 and notification number 2025B04969 [1] - The packaging specification is 30 tablets per bottle [1] Group 2: Regulatory Approval - The approval conclusion states that the product has passed the consistency evaluation of quality and efficacy according to relevant regulations [1] - The marketing authorization holder and manufacturing enterprise is Beijing Huasu Pharmaceutical Co., Ltd. [1]