Generic Drug Consistency Evaluation Makes New Progress: 1,042 Application Numbers Approved

　　【Pharmaceutical Network | Industry Trends] The purpose of conducting the consistency evaluation of quality and efficacy for generic drugs is to ensure that manufactured generic drugs can be clinically interchangeable with originator drugs. The consistency evaluation of generic drugs can alleviate the societal burden of pharmaceutical expenses, enhance the international competitiveness of Chinese pharmaceutical enterprises, and promote supply-side structural reforms in the pharmaceutical industry. Data shows that as of January 15, 2021, the Center for Drug Evaluation (CDE) had cumulatively accepted 2,685 application numbers for consistency evaluation, involving 576 varieties from 659 enterprises (counted as supplemental applications, hereinafter the same), among which 1,042 application numbers had passed the evaluation. From January 9 to January 15, the CDE received 25 new application numbers for consistency evaluation (covering 22 varieties); additionally, 11 varieties (13 specifications) passed the evaluation, including anti-cancer drugs, shortage drugs, and blockbuster injectables.
 

It is understood that since January 2021, many companies have issued announcements stating that their related products have passed the consistency evaluation. The author has compiled a portion of these for readers below.
 

Kelun Pharmaceutical’s “Medium/Long-Chain Fat Emulsion Injection (C8-24Ve)” Passes Consistency Evaluation
 

In a noon announcement on January 18, the company stated that it had recently received the “Notice of Approval for Supplemental Drug Application” issued and approved by the National Medical Products Administration (NMPA). Upon review, the company’s chemical drug “Medium/Long-Chain Fat Emulsion Injection (C8–24Ve)” has passed the consistency evaluation of quality and efficacy for generic drugs. Medium/long-chain fat emulsion injection is a widely used lipid emulsion in clinical practice, offering advantages such as rapid energy supply, efficient nitrogen sparing, and liver protection. It has been extensively recommended by domestic and international guidelines for patients with impaired liver function and those with tumors, among other conditions. Kelun Pharmaceutical stated that being the first in China to pass the consistency evaluation for this product will further enhance its market competitiveness.
 

Shanghai Pharma’s Cefradine Capsules Pass the Generic Drug Consistency Evaluation
 

On January 18, Shanghai Pharmaceuticals released an announcement stating that its controlled subsidiary, Shanghai New Asia Pharmaceutical Minhang Co., Ltd., recently received the “Notice of Approval for Supplemental Drug Application” (Notice No.: 2020B05358) issued by the National Medical Products Administration regarding Cefradine Capsules. This drug has passed the consistency evaluation for generic drugs.
 

Humanwell Healthcare’s Remifentanil Hydrochloride for Injection Passes the Generic Drug Consistency Evaluation
 

Humanwell Healthcare announced that its controlled subsidiary, Yichang Humanwell Pharmaceutical, received the "Notice of Approval for Supplementary Drug Application" from the National Medical Products Administration regarding Remifentanil Hydrochloride for Injection. The drug has passed the consistency evaluation of quality and efficacy for generic drugs. Remifentanil Hydrochloride for Injection is used for induction of general anesthesia and maintenance of analgesia during general anesthesia.
 

Qilu Pharmaceutical’s Ceftriaxone Sodium for Injection Passes Consistency Evaluation
 

Recently, Qilu Pharmaceutical’s supplementary application for the consistency evaluation of its anti-infective drug, Ceftriaxone Sodium for Injection, was approved by the National Medical Products Administration (NMPA), making it the company’s eighth injectable product to pass the evaluation. Ceftriaxone Sodium is a third-generation, broad-spectrum, long-actingCephalosporinsAnti-infective agents that exhibit stronger activity against Gram-negative bacteria compared to first- and second-generation cephalosporins. Clinically, they are primarily used for the treatment of sepsis, abdominal infections, bone/joint/soft tissue/skin and wound infections, renal and urinary tract infections, respiratory tract infections, and reproductive system infections caused by susceptible organisms.
 

Lunan Pharmaceutical's Ketorolac Tromethamine Tablets Pass the Consistency Evaluation
 

Lunan Pharmaceutical Group Corporation’s Shandong New Era Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for the consistency evaluation of quality and efficacy of its Ketorolac Tromethamine Tablets (brand name: Nisong; strength: 10 mg), becoming the first domestic product in tablet form to pass this evaluation. It is reported that Nisong Ketorolac Tromethamine Tablets are a non-steroidal anti-inflammatory drug (NSAID) with potent analgesic effects, widely used in clinical practice. They are indicated for the short-term treatment of moderately severe acute pain requiring opioid-level analgesia, typically for postoperative pain management, often administered alone or in combination with other opioids to alleviate moderate to severe postoperative pain.
 

Shijiazhuang No.4 Pharmaceutical's Product Passes Generic Drug Consistency Evaluation
 

On January 12, the Ciprofloxacin Lactate and Sodium Chloride Injection produced by Shijiazhuang No.4 Pharmaceutical Co., Ltd. became the first in China to be approved by the National Medical Products Administration (NMPA) and pass the Consistency Evaluation of Quality and Efficacy for Generic Drugs. Ciprofloxacin Lactate and Sodium Chloride Injection belongs to the fluoroquinolone class of antibiotics and is used for the treatment or prevention of various types of bacterial infections.
 

Aosaikang: Esomeprazole Sodium for Injection Passes Consistency Evaluation
 

Aosaikang announced that its wholly-owned subsidiary, Jiangsu Aosaikang Pharmaceutical Co., Ltd., recently received the "Notice of Approval for Supplementary Drug Application" issued and signed by the National Medical Products Administration (NMPA), approving the drug Esomeprazole Sodium for Injection (40 mg; 20 mg) to pass the Consistency Evaluation of Quality and Efficacy of Generic Drugs. The indications for Esomeprazole Sodium for Injection are: 1. As an alternative therapy for gastroesophageal reflux disease (GERD) when oral therapy is not applicable. 2. For low-risk patients with acute gastric or duodenal ulcer bleeding who are not suitable for oral therapy (Forrest classification IIc–III under endoscopy). 3. To reduce the risk of rebleeding after endoscopic treatment for gastric and duodenal ulcer bleeding in adults. 4. To prevent stress ulcer bleeding in critically ill patients.
 

Neptunus Bio-Engineering’s “Norfloxacin Capsules” Pass Consistency Evaluation
 

Neptunus Bio-Engineering issued an announcement stating that the Company received notice from its controlled subsidiary, Fuzhou Neptunus Fuyao Pharmaceutical Co., Ltd., informing it that Neptunus Fuyao had recently received the "Notice of Approval for Supplementary Drug Application" from the National Medical Products Administration (NMPA) regarding "Norfloxacin Capsules." This drug has passed the consistency evaluation of quality and efficacy for generic drugs. "Norfloxacin Capsules" is a prescription anti-infective medication indicated for urinary tract infections, gonorrhea, prostatitis, intestinal infections, typhoid fever, and other Salmonella infections caused by susceptible bacteria.
 

Yatai Pharmaceutical’s Metformin Hydrochloride Tablets Pass the Generic Drug Consistency Evaluation
 

In its evening announcement on January 6, the Company stated that it had recently received the “Notice of Approval for Supplementary Drug Application” approved and issued by the National Medical Products Administration (NMPA) regarding its Metformin Hydrochloride Tablets. The Company’s Metformin Hydrochloride Tablets have passed the consistency evaluation of quality and efficacy for generic drugs. It is reported that Metformin Hydrochloride Tablets are a biguanide oral hypoglycemic agent that reduces hepatic glucose production, inhibits intestinal absorption of glucose, and increases glucose uptake and utilization in peripheral tissues, thereby improving insulin sensitivity by enhancing peripheral glucose uptake and utilization.
 

Xinhua Pharmaceutical’s Broad-Spectrum Oral Antibiotic Cephalexin Tablets Pass the Consistency Evaluation
 

On January 5, Xinhua Pharmaceutical announced that its generic oral broad-spectrum antibiotic cephalexin tablets (0.125 g and 0.25 g) had passed the consistency evaluation, making it the first company in China to achieve this milestone for this product.