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仙琚制药(002332.SZ):杨府厂区原料药产品通过日本GMP符合性检查
格隆汇 12-13 17:17

格隆汇12月13日丨仙琚制药(002332.SZ)公布,近日,公司收到日本独立行政法人医药品及医疗器械综合机构(PMDA)签发的《医药品适合性调查结果通知书》,公司杨府原料药厂区的泼尼松龙原料药通过日本GMP符合性检查。该次通过日本GMP符合性检查的泼尼松龙原料药,是公司杨府厂区原料药产品首次通过日本药品监管部门审查。

泼尼松龙是一种强效糖皮质激素,其为前药泼尼松的活性代谢物,广泛用于抗炎和免疫抑制,泼尼松龙已被列入WHO基本药物清单。泼尼松龙在治疗各种急性和慢性疾病,包括哮喘、肝炎、关节炎、系统性红斑狼疮和过敏性皮肤病中表现出更高的抗炎活性和更低的钠潴留。

此次通过日本PMDA的GMP认证,标志着公司杨府原料药厂区的泼尼松龙原料药获得日本市场的准入资格,将对公司拓展日本及其他海外原料药规范市场带来积极影响。公司将保持稳定的生产管理和质量保证体系,更好地满足全球客户需求,保障公司可持续发展。

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