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【Pharmaceutical Network Industry News】For pharmaceutical companies, the consistency evaluation of the company's products will be conducive to the future market sales of the drug, and can prepare
for the centralized procurement ticket.
Therefore, pharmaceutical companies have been very active
in promoting consistency evaluation in recent years.
Data show that in October this year, CDE undertook a total of 218 newly registered generic drug consistency evaluation application acceptance numbers
.
It is worth noting that a number of pharmaceutical companies have recently announced that their products have been evaluated
.
On November 23, Jingfeng Pharmaceutical announced that the chemical drug "tirofiban hydrochloride concentrated solution for injection" of its subsidiary Guizhou Jingfeng Injection Co.
, Ltd.
was approved and issued by the State Food and Drug Administration (NMPA), and the drug passed the consistency evaluation
of the quality and efficacy of generic drugs.
It is understood that the concentrated solution of tirofiban hydrochloride injection is an antiplatelet aggregation drug, which is clinically used in adult patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS) with ECG changes and/or elevated myocardial enzymes within 12 hours of the last chest pain attack to prevent early myocardial infarction
.
According to public information, the concentrated solution for tirofiban hydrochloride for injection is a Class B variety of national medical insurance in 2021, and in 2021, the sales of the drug in China will be about 170 million yuan
.
On the same day, Combe issued an announcement that its holding subsidiary Jinhua Kangbei product acetylcysteine granules received the "Drug Registration Certificate"
approved and issued by the State Food and Drug Administration.
It is reported that Jinhua Kangbei acetylcysteine granules have been approved for marketing in Class 4 of chemical drug registration classification, and the product is deemed to have passed the consistency evaluation
of generic drugs.
Acetylcysteine granules are sputum dissolving agents, which can be combined with bronchodilators and vasoconstrictors and other drugs, and are suitable for sputum difficulty caused by thick sputum, and mucus sputum is not easy to cough up
.
In 2021, the domestic sales amount of acetylcysteine (including solutions, tablets, effervescent tablets, granules) in the corresponding retail and medical terminal markets totaled 4.
038 billion yuan, a year-on-year increase of 31%, of which the sales amount of granules was 230 million yuan, a year-on-year increase of 15.
4%.
On November 19, China National Pharmaceutical announced that its wholly-owned subsidiary, Hainan GM Sanyo, received the "Drug Supplement Application Approval Notice" approved and issued by the State Food and Drug Administration for cefotiam hydrochloride for injection, which passed the consistency evaluation
of the quality and efficacy of generic drugs 。 Ceftiam hydrochloride is a semi-synthetic second-generation cephalosporin antibiotic, which belongs to the β-lactam class of antibiotics, which has a wide range of antibacterial effects on gram-negative bacteria and gram-positive bacteria, and is suitable for infections caused by staphylococcus, streptococcus (except enterococci), pneumococcus, influenza bacillus, Escherichia coli, Proteus vulgaris, Proteus retterii, Proteus morganii, etc
.
In 2021, the domestic sample hospital sales of the drug were about 182 million yuan
.
Up to now, in addition to China Medicine, many domestic manufacturers such as General Sanyo, Liaoning Haisco, Shandong Luoxin Pharmaceutical, Yongning Pharmaceutical, and Shenghuaxi have passed the consistency evaluation
of the drug.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.