Over 2,700 Generic Drug Specifications Passed Consistency Evaluation in 2023, Involving More Than 800 Pharmaceutical Companies

　　【Pharmaceutical Network Industry DynamicsIn recent years, the National Medical Products Administration (NMPA) has been steadily advancing the consistency evaluation of quality and efficacy for generic drugs. According to statistical data, the number of drugs passing the evaluation in 2023 grew rapidly, with a total of 2,713 specifications of generic drugs passing the consistency evaluation (including generics approved under the new chemical drug registration classification, i.e., "deemed to have passed"), representing a year-on-year increase of 42.86%, involving 742 varieties.
 

According to data statistics, the generic drugs that passed the quality and efficacy consistency evaluation in 2023 involved 811 pharmaceutical companies. Among them, SSY Group Limited had 45 drugs passing the evaluation; Kelun Pharmaceutical had 39 drug specifications passing the evaluation; BRILLIANT PHARMACEUTICALS had 37 drug specifications passing the evaluation; Qilu Pharmaceutical and HISUN had 30 and 27 drugs passing the evaluation respectively.
 

Among them, SSY Group Limited has four specifications of first-to-market generic products, involving three varieties: sodium bicarbonate injection, pentoxifylline sustained-release tablets, and stiripentol dry suspension, which is listed as an orphan drug. BRILLIANT PHARMACEUTICALS has six specifications of first-to-market generics, covering five varieties: ceftazidime avibactam sodium / sodium chloride injection, cefuroxime sodium / sodium chloride injection, cefoxitin sodium / glucose injection, sodium lactate Ringer's injection, and posaconazole oral suspension. Qilu Pharmaceutical Co., Ltd. has eight specifications of first-to-market generics, involving five varieties: paliperidone palmitate injection, dolutegravir sodium tablets, octreotide acetate microsphere injection, pazopanib tablets, and probucol tablets.
 

According to reports, since entering 2024, a large number of products have passed the evaluation. For instance, SSY Group Limited recently announced that its Potassium Chloride Injection (20ml:3.0g) has received approval from the National Medical Products Administration of China for the consistency evaluation of quality and efficacy of generic drugs, making it the first domestically produced product to receive such approval.
 

SPH recently announced that its Meropenem for Injection has passed the generic drug consistency evaluation. Meropenem for Injection is mainly used for infections in adults and children caused by single or multiple bacteria sensitive to meropenem.
 

Wanbangde Pharmaceutical's Lidocaine Hydrochloride Injection Passes Generic Drug Quality and Efficacy Consistency Evaluation. Lidocaine Hydrochloride Injection is a local anesthetic and antiarrhythmic drug. It is mainly used for infiltration anesthesia, epidural anesthesia, surface anesthesia (including mucosal anesthesia during thoracoscopy or abdominal surgery), and nerve conduction block. It can also be used for ventricular premature beats and ventricular tachycardia after acute myocardial infarction, as well as for digitalis toxicity and cardiac...Surgical OperationAnd ventricular arrhythmias induced by cardiac catheterization.
 

The United Laboratories (Inner Mongolia) Co., Limited's Imipenem and Cilastatin Sodium for Injection (specifications: 0.5g; 1.0g) has passed the consistency evaluation of quality and efficacy for generic drugs. Imipenem and Cilastatin Sodium for Injection is a very broad-spectrum antibiotic, clinically suitable for mixed infections caused by multiple pathogens and aerobic/anaerobic bacteria, as well as early treatment before the pathogen is identified. It is suitable for the treatment of infections caused by susceptible bacteria such as intra-abdominal infections, lower respiratory tract infections, gynecological infections, sepsis, etc.
 

HISUN's Cycloserine Capsules have passed the quality and efficacy consistency evaluation for generic drugs. Cycloserine Capsules are suitable for the treatment of active pulmonary tuberculosis and extrapulmonary tuberculosis (including renal tuberculosis) caused by Cycloserine-sensitive Mycobacterium tuberculosis that shows poor response to first-line anti-tuberculosis drugs (such as streptomycin, isoniazid, rifampicin, and ethambutol).
 

It is reported that the "Opinions on Carrying Out the Consistency Evaluation of Quality and Efficacy of Generic Drugs" was released in 2016, which pointed out that, to encourage enterprises to carry out consistency evaluation work, if the number of production enterprises of the same variety of drugs passing the consistency evaluation reaches more than three, those varieties that have not passed the consistency evaluation will no longer be selected in drug centralized procurement and other aspects. For large varieties of drugs, passing the consistency evaluation means obtaining the qualification to enter the centralized procurement list, and other drugs passing the consistency evaluation can also effectively enhance their competitive advantages.
 

Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.