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CR Double-Crane’s Sodium Valproate Tablets Fluconazole and Sodium Chloride Injection Passing Consistency Evaluation of Generic Drugs

Press time:2021-08-04From:CR Pharma [ Font:BigMediumSmall]

On August 4, CR Double-Crane issued an announcement that the Sodium Valproate Tablets produced by Hunan Xiangzhong Pharmaceutical Co., Ltd. and the Fluconazole and Sodium Chloride Injection of CR Double-Crane (Anhui) passed the consistency evaluation of the quality and efficacy of generic drugs on July 22 and July 19, 2021, respectively, and both companies had received the acceptance notices of drug supplementary registration application (notice numbers: 2021B02364, 2021B02289). In addition, Xiangzhong Pharmaceutical is the third pharmaceutical company to pass the consistency evaluation of the oral dosage form of sodium valproate. 

Sodium valproate tablets are mainly used for the treatment of generalized, partial or other types of epilepsy.  

In 1967, the sodium valproate enteric-coated tablets produced by Sanofi was approved for marketing in France under the brand name Depakin. In 1989, Japan confirmed that the sodium valproate tablets produced by Kyowa Hakko Kirin Co., Ltd. were a reference preparation through its re-evaluation of drug consistency. In 1978, the two specifications of sodium valproate tablets (sugar-coated tablets), 0.2g and 0.1g, produced by Xiangzhong Pharmaceutical were approved for marketing in China; in 2012, the companys 0.2g sodium valproate tablets (film-coated tablets) obtained approval for marketing in China.  

The dosage form produced by Xiangzhong Pharmaceutical is sodium valproate tablets. According to data on Menet, the total sales (based on retail prices) of domestic sodium valproate oral preparations in 2020 were RMB 899 million, among which the sales of sodium valproate tablets produced by Xiangzhong Pharmaceutical accounted for 6.76%, ranking fourth. 

Fluconazole and sodium chloride injection is an antifungal drug mainly used for patients with severe candidiasis, cryptococcosis, and coccidioidomycosis symptoms. The product can also replace Itraconazole for the treatment of blastomycosis and histoplasmosis. 

Fluconazole sodium chloride injection was developed by Pfizer, and it was first launched under the trade name Diflucan in the United States in 1990, and then in Japan in 2006. According to data on Menet, there are 84 pharmaceutical companies in the Chinese mainland that have obtained approvals for the marketing of fluconazole sodium chloride injection, and 4 of them (including CR Double-Crane (Anhui)) have passed drug consistency evaluations. In 2020, the total domestic sales of fluconazole sodium chloride injection (based on retail prices) were RMB 890 million. 

After passing the consistency evaluations, CR Double-Crane has further enhanced the competitiveness of its products and gained valuable experience for conducting consistency evaluation of other generic drugs in the future, which will benefit its operations. 

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