The consistency evaluation of 513 varieties of generic drugs has passed the review, and since July, there have been many products from pharmaceutical companies.

【Pharmaceutical Network Industry News】Whether it passes the consistency evaluation of generic drugs is one of the important indicators for the country to purchase drugs in a centralized mann.
Recently, Yuan Lin, director of the Drug Supervision Department of the State Food and Drug Administration, introduced that as of now, the State Food and Drug Administration has reviewed and approved 513 varieties of generic drug consistency evaluation applications involving 2,555 product specifications, and the quality of the listed generic drugs has been continuously improv.
The improvement has provided strong support for deepening the reform of the medical and health syst.
Yuan Lin also said at the meeting that in recent years, the State Drug Administration has continued to promote the reform of the drug review and approval system to maintain the stability and improvement of the drug safety situati.
According to statistics, since 2019, more than 2,000 applications for drug marketing registration have been approv.
In 2019, 2020 and 2021, there were 143, 217 and 219 registration applications that passed priority review and approval for listing, respective.
A batch of new and good drugs with obvious clinical value and meeting urgent clinical needs were approved for marketing, which further satisfied the publ.
medication nee.
It is understood that since July, another batch of drugs has passed the consistency evaluation of generic dru.
Lukang Pharmaceutical's Subsidiary Drugs Passed the Consistency Evaluation of Generic Drugs On July 20, Lukang Pharmaceutical announced that its holding subsidiary Shandong Lukang Pharmaceutical Group Saite .
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(hereinafter referred to as "Saite Company") received the National Drug Administration The "Drug Supplementary Application Approval" (Approval .
: 2022B02704) issued by the Administration for Isosorbide Mononitrate Sustained-Release Tablets (hereinafter referred to as "the drug"), the drug has passed the quality and efficacy consistency evaluation of generic dru.
Isosorbide mononitrate tablets were first developed by German manufacturer BoehringerMannheim, GmbH and launched in 198Mainly used for long-term treatment of coronary heart disease; prevention of angina pectoris; treatment of persistent angina pectoris after myocardial infarction; combined with digitalis and/or diuretics to treat chronic congestive heart failure
China Resources Shuanghe Enoxaparin Sodium Injection passed the quality and efficacy consistency evaluation of generics On July 7, it obtained the "Approval Notice for Supplementary Drug Application" (the notice numbers are: 2022B02777 and 2022B02778) from the State Food and Drug Administration, and was approved to pass the consistency evaluation of the quality and efficacy of generic dru.
This medicinal product is used for the prevention of venous thromboembolic disease (prevention of venous thrombosis), especially those associated with orthopaedic or general surgery; for the treatment of established deep vein thrombosis, with or without pulmonary embolism, with no clinical symptoms Severe, excluding pulmonary embolism requiring surgery or thrombolytic therapy; combined with aspirin to treat unstable angina and non-Q-wave myocardial infarction; used in hemodialysis extracorporeal circulation to prevent thrombos.
Baiyunshan: The branch company's cefradine capsules passed the consistency evaluation of generic dru.

Baiyunshan recently issued an announcement: the branch company, Guangzhou Baiyunshan Pharmaceutical Group .

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Baiyunshan Pharmaceutical Factory ("Baiyunshan Pharmaceutical Factory") received the National Drug Administration The "Notice of Approval of Supplementary Drug Application" (Notice Number: 2022B02676, 2022B02677) issued by the Bureau, Cefradine Capsules (125g, 25g) have passed the quality and efficacy consistency evaluation of generic dru.

Cefradine is a first-generation cephalosporin antibiotic, suitable for acute pharyngitis, tonsillitis, otitis media, bronchitis, pneumonia and other respiratory tract infections, genitourinary tract infections and skin and soft tissue infections caused by sensitive bacter.

Sialon Pharmaceuticals: Argatroban Injection passed the consistency evaluation of generic drugs Sialon Pharmaceuticals announced on the evening of July 18 that Hunan Sailon Pharmaceutical .

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, a wholly-owned subsidiary of the company, has recently been approved and issued by the State Food and Drug Administrati.

Argatroban Injection "Approval Notice for Supplementary Drug Applicatio.
After review, the supplementary application for adding 2ml:10mg of this product was approved, and the drug approval number was issu.

This product passed the consistency evaluation of the quality and efficacy of generic dru.

Changshan Pharmaceutical: Enoxaparin Sodium Injection passed the consistency evaluation of generic dru.

Changshan Pharmaceutical announced that the company has recently received the "Approval Notice for Supplementary Drug Application" approved and issued by the State Drug Administrati.

Sodium injection passed the quality and efficacy consistency evaluation of generic dru.

Tianyao's "Dexamethasone Acetate Tablets" passed the consistency evaluation of generic drugs Recently, the dexamethasone acetate tablets produced by Tianyao .

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passed the consistency evaluation of generic dru.

Among the 81 companies currently approved for listing in the domestic market, the company is the first company to pass the consistency evaluation of this drug in Chi.

It is reported that dexamethasone acetate tablets are mainly used for allergic and autoimmune inflammatory diseases, such as connective tissue disease, severe bronchial asthma, dermatitis and other allergic diseases, ulcerative colitis, acute leukemia, malignant lymphoma,e.

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