More than 20 new drugs passed the consistency evaluation within one week

 Carrying out the consistency evaluation of generic drugs can make generic drugs consistent with the original drugs in terms of quality and efficacy, and can replace the original drugs clinically.
This not only saves medical costs, but also improves the quality of China's generic drugs and the overall pharmaceutical industry.
The level of development to ensure the safe and effective use of medicines by the public
.
According to statistics, there are currently 3,523 product regulations in China that have passed the consistency evaluation, and 406 product regulations have been evaluated by more than three (including three)
.
Among them, from December 19, 2021 to December 25, 2021, 23 new varieties (deemed as the same) passed the consistency evaluation, and a number of pharmaceutical companies were the first to review
.
For example, on December 24, the hydroxychloroquine sulfate tablets of Shanghai Shanghai Pharmaceutical Zhongxi Pharmaceutical passed the consistency evaluation and became the first reviewer of this variety
.
Data show that hydroxychloroquine sulfate was marketed in the United States in 1955 for malaria, rheumatoid arthritis, and lupus erythematosus, and was subsequently approved for marketing in more than 70 countries
.
It is understood that the drug currently has Fujian Haixi New Drug Creation/Fu'an Pharmaceutical, Xi’an Haixin Pharmaceutical, and Jiangsu Zhiyuan Pharmaceutical have submitted hydroxychloroquine sulfate listing applications with new registrations in four categories.
Suzhou Long March-Xinkai Pharmaceutical launched And publicized the BE test
.
Jiangsu Chenpai Pharmaceutical Voglibose Dispersible Tablets also passed the consistency evaluation and became the first domestic enterprise to pass the evaluation
.
Voglibose indication is to improve diabetic postprandial hyperglycemia
.
According to data, in China, the approved preparations of voglibose include voglibose tablets, voglibose dispersible tablets, voglibose chewable tablets, and voglibose capsules
.
Tablets are the main sales formulations, accounting for up to 93.
19%
.
In 2020, the sales scale of [Voglibose] in public hospitals in key provinces and cities in China will be approximately 124 million yuan
.
The author also learned that Huahai Pharmaceutical's rocuronium injection has also passed the drug consistency evaluation recently
.
Data show that rocuronium injection is an adjuvant general anesthesia, used for tracheal intubation during conventional induction anesthesia, and to maintain intraoperative skeletal muscle neuromuscular block
.
The drug was developed by ORGANON and was approved for marketing in the European Union and the United States in 1994
.
In July 2018, Huahai Pharmaceutical obtained the Drug Registration Approval for Rocuronium Injection approved and issued by the State Food and Drug Administration; in December 2021, the product was approved by the State Food and Drug Administration and passed the drug consistency evaluation
.
The third-generation quinolone antibiotic norfloxacin capsules of the Baiyunshan branch company's Baiyunshan Pharmaceutical General Factory have recently passed the consistency evaluation of generic drugs
.
Yunshan Pharmaceutical General Factory has invested approximately RMB 6,937,300 in research and development for the consistency evaluation of the drug (unaudited)
.
It is reported that Norfloxacin is a third-generation quinolone antibiotic with a broad-spectrum antibacterial effect, especially high antibacterial activity against aerobic gram-negative bacilli.
It is clinically used for urinary tract infections, gonorrhea, prostatitis, and prostatitis caused by sensitive bacteria.
Intestinal infections and typhoid fever and other salmonella infections
.
In addition, Osaikang also recently disclosed an announcement on the consistency evaluation of its subsidiary tigecycline for injection through generic drugs
.
This product is clinically mainly used for the treatment of infections caused by sensitive strains of specific bacteria in patients over 18 years of age: complicated intra-abdominal infections, complicated skin and skin soft tissue infections, and community-acquired bacterial pneumonia
.
The company declared the consistency evaluation of the quality and efficacy of generic drugs in March 2020, and was approved recently
.
According to the industry, in accordance with relevant national policies, the types, quality and efficacy of medicines that have passed the consistency evaluation are equivalent to the original research products, and appropriate support will be given in terms of medical insurance payment and procurement by medical institutions
.
In the context of the country's policy of encouraging preferential procurement and use of products that have passed the consistency evaluation, the consistency evaluation of related drugs through generic drugs is conducive to further enhancing the technical advantages of the drug, enhancing market competitiveness, and expanding market share
.