Twelve Generic Drugs Pass Consistency Evaluation, Five Achieve First-to-Pass Status

Today, according to the information on pending collection of drug approval documents published on the official website of the National Medical Products Administration (NMPA), a total of 12 generic drugs passed the consistency evaluation. According to data compiled from the PharmaGo database by PharmaCube, five of these were first-time approvals, namely: Granisetron Hydrochloride Injection by Qilu Pharmaceutical, Roxithromycin Dispersible Tablets by Jiangsu Shenlong Pharmaceutical Co., Ltd., Cimetidine Tablets by TOPFOND PHARMACEUTICAL CO.,LTD., Tranexamic Acid Injection by REYOUNG PHARMACEUTICAL CO., LTD., and Ketotifen Fumarate Tablets by Suzhou Homesun Pharmaceutical Co., Ltd.

Granisetron HydrochlorideSiqiong Injection

Granisetron Hydrochloride Injection is a selective 5-HT3 receptor antagonist, clinically used primarily for the prevention and treatment of nausea and vomiting induced by radiotherapy, chemotherapy, and surgery. Qilu Pharmaceutical was the first company to pass the consistency evaluation for this product.

Currently, there are as many as 29 manufacturers in China with valid approval numbers for this product. According to the IPM market database of PharmaCube, the sales revenue of this product in domestic hospitals with more than 100 beds was approximately RMB 160 million in 2019, with Ningbo Tianheng Pharmaceutical of Fuan Pharmaceutical Group holding around 80% of the market share. Furthermore, data from the PharmaGo database of PharmaCube indicates that Fuan Pharmaceutical Group is also submitting an application for consistency evaluation for this product, and Chengdu Better Pharmaceuticals has also submitted its consistency evaluation application.

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Cimetidine Tablets

Cimetidine Tablets are histamine H2 receptor antagonists, clinically indicated primarily for the treatment of duodenal ulcers, gastric ulcers, reflux esophagitis, stress ulcers, and Zollinger-Ellison syndrome. This product is available as an over-the-counter (OTC) medication. Although there are 14 manufacturers marketing this product, only three pharmaceutical companies have submitted applications for consistency evaluation. TOPFOND PHARMACEUTICAL CO.,LTD. was the first company to pass the evaluation, while Shanghai Baolong Pharmaceutical and Shanghai Sine Tianping Pharmaceutical are currently applying for consistency evaluation.

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Tranexamic Acid Injection

Tranexamic acid is an antifibrinolytic agent, clinically used to treat various types of bleeding caused by acute or chronic, localized or systemic primary hyperfibrinolysis. REYOUNG PHARMACEUTICAL CO., LTD. is the first company to pass the consistency evaluation for this product.

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In addition, Yangtze River Pharmaceutical Group Co.,Ltd., Hunan Sailong, Shanxi Powerdone Pharmaceutics Co., Ltd., and CHENGDU LEER PHARMACEUTICAL CO.,LTD. have also submitted applications for the consistency evaluation of this product.