NMPA Approves 67 New Drug Applications, Including 11 Consistency Evaluation Filings; Chongqing Lummy Pharma's Ramosetron Hydrochloride Injection Becomes First-to-Pass

Nov 07, 2023 20:30 CST Updated 20:30

Qilu Pharmaceutical

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Just now, NMPA released the drug approval certificate delivery information on November 7, 2023.This batch has 67 approval numbers granted.Among them, 11 are acceptance numbers for consistency evaluation, and the approved varieties include:

Chongqing Lummy Pharmaceutical Co., Ltd., Ramosetron Hydrochloride Injection

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Doxorubicin Hydrochloride Liposome Injection

Qilu Pharmaceutical Co., Ltd., Sodium Esomeprazole for Injection

BRILLIANT PHARMACEUTICALS, Piperacillin Sodium for Injectionetc.

Among them, Chongqing Lummy Pharmaceutical Co., Ltd.Ramosetron Hydrochloride InjectionThe first to pass the evaluation.

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical's Doxorubicin Hydrochloride Liposome Injection is the 5th product to pass the evaluation/be regarded as passing the evaluation. The other four companies that passed the evaluation are: CSPC Ouyi Pharmaceutical, Changzhou Jinyuan Pharmaceutical, Zhejiang Shengzhao Pharmaceutical, and Zhejiang Zhida Pharmaceutical.

Another product has been approved for marketing this time: Epronelimab for Injection from Wuhan Hiteck Biopharmaceutical Co., Ltd., as previously announced by NMPA. This drug, in combination with thalidomide and dexamethasone, is indicated for adult patients with relapsed or refractory multiple myeloma who have previously received at least two systemic treatment regimens.

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