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国药现代(600420.SH)子公司注射用盐酸瑞芬太尼通过仿制药一致性评价

Sinopharm Hyundai (600420.SH) subsidiary injectable remifentanil hydrochloride passed generic drug consistency evaluation

Zhitong Finance ·  Mar 15 05:11

Sinopharm Hyundai (600420.SH) issued an announcement. Recently, Sinopharm Group Industrial Co., Ltd., a wholly-owned subsidiary of the company (...

Zhitong Finance App News, Sinopharm Hyundai (600420.SH) issued an announcement. Recently, Sinopharm Group Industry Co., Ltd. (hereinafter referred to as Sinopharm Industry), a wholly-owned subsidiary of the company, received the “Drug Supplement Application Approval Notice” approved and issued by the State Drug Administration to approve the approval of injectable remifentanil hydrochloride to pass the consistent evaluation of generic drug quality and efficacy. Injectable remifentanil hydrochloride is used for sedation and analgesia during induction and maintenance of total anesthesia.

According to the CDE website, currently companies that have passed/treated as having passed the consistency evaluation with injectable remifentanil hydrochloride include Yichang Renfu Pharmaceutical Co., Ltd. and Jiangsu Enhua Pharmaceutical Co., Ltd. Up to now, the Sinopharm industry has invested approximately RMB 8.411,000 (unaudited) to carry out the consistency evaluation of remifentanil hydrochloride for injection.

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