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CR Double-Crane announced on January 22^nd that its wholly-owned subsidiary Double-Crane Pharmaceutical (Anhui) received the Approval Document from the National Medical Products Administration (“NMPA”) on Drug Supplementary Application for Metronidazole and Sodium Chloride Injection (100ml) on January 5^th(Document No.: 2022B00015), which marked that the drug had passed the consistency evaluation of quality and efficacy of generic drugs.

Metronidazole: An Overview

Metronidazole is a nitroimidazole derivative mainly used to treat severe anaerobic bacterial infections including intra-abdominal infections, skin and soft tissue infections, gynecologic infections, and lower respiratory tract infections, as well as to prevent anaerobic bacterial infections following elective colorectal surgery.

Development History

Flagyl(Metronidazole and Sodium Chloride Injection) was introduced by Sanofi-Aventis to the Spanish market in 1979. According to the currently available drug sales databases of 71 countries, the global sales of Flagyl？ in 2020 totaled up to USD 8.52 million. According to NMPA, the Chinese mainland now has 110 approved manufacturers of 100ml Metronidazole and Sodium Chloride Injection, five of which have passed the consistency evaluation of generic drugs, including Anhui Double-Crane. The annual sales of Anhui Double-Crane for Metronidazole and Sodium Injection in 2021 was RMB 17.05 million.

The passing of consistency evaluation will further boost the market competitiveness of the company’s products and help accumulate experience in passing the evaluation for other products.