The consistency evaluation of generic drugs in my country is progressing smoothly, and a large number of products have been reviewed in November

In recent years, in order to promote the consistency evaluation of generic drugs, China has issued a series of technical documents, guidelines, notices, etc.
that have a guiding role in the consistency evaluation, guiding and helping companies to pass the consistency evaluation as soon as possible
.
From the current point of view, the consistency evaluation of generic drugs in China is progressing smoothly, and the consistency evaluation has become normalized and institutionalized
.
It is understood that since November, a large number of companies have announced that related products have passed the consistency evaluation, and the author has sorted out some of the products that have been reviewed
.
Shanghai Pharmaceuticals: Clozapine tablets passed the consistency evaluation of generic drugs.
Shanghai Pharmaceuticals announced that recently, the company’s wholly-owned subsidiary Shanghai Shangyao Xinyi Pharmaceutical Co.
, Ltd.
("Shangyao Xinyi") received a certificate from the State Drug Administration Regarding the "Notice of Approval of Drug Supplement Application" for clozapine tablets (notice number: 2021B04174), the drug passed the consistency evaluation of generic drugs
.
Clozapine tablets are mainly used for refractory schizophrenia.
They were developed by Swiss Sandoz (predecessor of Novartis) and were launched in Switzerland and Australia in 1972
.
In May 2020, Shanghai Pharmaceutical Xinyi submitted an application to the State Food and Drug Administration for the consistency evaluation of the generic drug and was accepted
.
As of the date of this announcement, the company has invested approximately RMB 9,986,800 in research and development costs for the consistency evaluation of the drug
.
Kelun Pharmaceutical: Oseltamivir Phosphate Capsules Passed the Consistency Evaluation Recently, Kelun Pharmaceutical Oseltamivir Phosphate Capsules passed the consistency evaluation of generic drugs
.
Oseltamivir, as an oral neuraminidase inhibitor, has the advantages of reducing influenza complications, hospitalization and mortality.
It is the first-line treatment for influenza recommended by the National Health Commission and WHO.
It is not only used in children with type A and Influenza B is widely used in diagnosis and treatment, and it can also play a good preventive role in adolescents and adults
.
At present, Kelun Pharmaceutical has formed a cluster advantage among generic drugs.
The approval of Oselveta Phosphate Capsules has added new members to the team of Kelun Pharmaceutical's generic drugs and further strengthened its advantages in the development of generic drugs.

.
Baiyunshan: Cefprozil granules passed the generic drug consistency evaluation.
Baiyunshan announced that the company's branch Baiyunshan Pharmaceutical General Factory received the "Drug Supplementary Application Approval Notice" issued by the National Medical Products Administration.
Cefprozil granules have passed the quality of generic drugs And evaluation of consistency of efficacy
.
Cefprozil is a second-generation cephalosporin oral antibacterial drug, which has the characteristics of broad antibacterial spectrum, high activity and stability to β-lactamase
.
Hausen Pharmaceuticals: 4 types of generic fulvestrant injections were approved.
Recently, the State Food and Drug Administration showed that Hausen Pharmaceuticals 4 types of generic fulvestrant injections have been approved for production and deemed to have been reviewed and are domestically produced.
No.
2
.
Fulvestrant is a down-regulator of estrogen receptor (ER), which can block the binding of estrogen and ER.
It is clinically used for relapse after or during the course of anti-estrogen adjuvant therapy, or in anti-estrogen therapy The original manufacturer of advanced postmenopausal ER+ or metastatic breast cancer is AstraZeneca
.
Jiangsu Wuzhong: Azithromycin for injection passed the consistency evaluation of generic drugs.
Jiangsu Wuzhong announced that recently, the company’s wholly-owned subsidiary Jiangsu Wuzhong Medicine Group Co.
, Ltd.
Subsidiary Jiangsu Wuzhong Medicine Group Co.
, Ltd.
Suzhou Pharmaceutical Factory ("Suzhou Pharmaceutical Factory" ") received the "Drug Supplementary Application Approval Notice" on "Azithromycin for Injection" approved and issued by the State Drug Administration ("SFDA").
The drug passed the generic drug quality and efficacy consistency evaluation ("Imitation Pharmaceutical consistency evaluation")
.
The announcement showed that azithromycin belongs to the macrolide antibiotic
.
Antibacterial spectrum of these drugs and antibacterial activity substantially similar for most Gram-positive bacteria, Legionella, Chlamydia, Mycoplasma, anaerobic bacteria having excellent antibacterial effect
.
Hisun Pharmaceuticals: Vancomycin Hydrochloride for Injection passed the consistency evaluation of generic drugs.
Hisun Pharmaceuticals issued an announcement stating that the company has received the "Drug Supplementary Application Approval Notice" for Vancomycin Hydrochloride for Injection approved and issued by the State Food and Drug Administration.
, The company's drug injection vancomycin hydrochloride has passed the quality and efficacy consistency evaluation of generic drugs
.
Intravenous drip of vancomycin hydrochloride for injection is suitable for infections caused by methicillin-resistant Staphylococcus aureus and other bacteria
.
Vancomycin (Vancomycin) was developed by Eli Lilly and Company, and was listed in the United States in 1958; Vancomycin hydrochloride for injection was listed in China in 1996
.
At present, the main domestic manufacturers of vancomycin hydrochloride for injection include Livzon Group Livzon Pharmaceutical Factory and Zhejiang Pharmaceutical Co.
, Ltd.
Xinchang Pharmaceutical Factory
.
Xiangyu Pharmaceutical: Difenidol Hydrochloride Tablets and Captopril Tablets Passed Generic Drug Consistency Evaluation The "Drug Supplement Application Approval Notice" for difenidol hydrochloride tablets and captopril tablets (notice numbers: 2021B04088 and 2021B04090, respectively), approved the above two varieties to pass the quality and efficacy consistency evaluation of generic drugs
.
Difenidol hydrochloride tablets are mainly used to prevent dizziness, nausea, and vomiting caused by various reasons or diseases, such as motion sickness when traveling by car, ship, or airplane
.
At present, a total of 28 domestic manufacturers hold production approvals for difenidol hydrochloride tablets, and 2 of them have passed the consistency evaluation
.
Captopril tablets mainly treat hypertension and heart failure
.
At present, a total of 251 domestic manufacturers hold captopril tablets production approval, 17 have passed the consistency evaluation, and 10 have been reviewed for consistency evaluation
.
Tianyao shares: the drug norepinephrine bitartrate injection passed the consistency evaluation of generic drugs The “Notice of Approval of Supplementary Application for Drugs” approved the drug to pass the quality and efficacy consistency evaluation of generic drugs
.
It is understood that norepinephrine bitartrate injection can be used to control blood pressure in some state of acute hypotension, as a means of adjuvant therapy, to treat shock caused by hypovolemia, resuscitation after cardiac arrest to maintain blood pressure and so on
.
At present, there are 7 domestic companies whose norepinephrine bitartrate injections have been approved for listing
.
Xinhua Pharmaceutical: Aminophylline injection passed the consistency evaluation of generic drugs.
Xinhua Pharmaceutical announced that the company recently received the "Drug Supplementary Application Approval Notice" for aminophylline injection (10ml: 0.
25g) approved and issued by the National Medical Products Administration.
, The product passed the quality and efficacy consistency evaluation of generic drugs
.
Aminophylline injection is suitable for bronchial asthma, chronic asthmatic bronchitis, chronic obstructive pulmonary disease, etc.
, and can relieve wheezing symptoms; it can also be used for cardiac insufficiency and cardiogenic asthma
.
Sinopharm Hyundai: Octreotide acetate injection passed the consistency evaluation of generic drugs.
Sinopharm Hyundai issued an announcement stating that its holding subsidiary Sinopharm Yixin recently received the “Approval Notice of Drug Supplement Application Approval” for Octreotide Acetate Injection approved and issued by the National Medical Products Administration.
The drug was approved to pass the consistency evaluation of generic drugs
.
Octreotide acetate is a synthetic octapeptide compound that can inhibit the response of luteinizing hormone to gonadotropin releasing hormone, reduce visceral blood flow, and inhibit serotonin, gastrin, vasoactive intestinal peptide, chymotrypsin, and motilin , The secretion of glucagon
.
It is mainly suitable for acromegaly and some gastrointestinal carcinoids and neuroendocrine tumors that require long-term administration
.
Octreotide acetate was originally developed by Novartis
.
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In November, a large number of products were over-evaluated, and the generic drug consistency evaluation Next article: Seventh Prediction of batch collection of anti-tumor drugs! Over 4 billion marketPrevious article: Looking forward to 2022, which segments of the pharmaceutical and biological sector have great potential? [Information Search] [Add to Favorites] [Tell a friend] [Print this article] [Close the window] Similar information js?cdnversion='+~(-new Date()/36e5)]; Keywords: my country's generic drug consistency evaluation work is progressing smoothly.
In November, a large number of products were over-evaluated, and the generic drug consistency evaluation Next article: No.
Seven batches of anti-tumor drugs are forecasted! Over 4 billion marketPrevious article: Looking forward to 2022, which segments of the pharmaceutical and biological sector have great potential? [Information Search] [Add to Favorites] [Tell a friend] [Print this article] [Close the window] Similar information js?cdnversion='+~(-new Date()/36e5)]; Keywords: my country's generic drug consistency evaluation work is progressing smoothly.
In November, a large number of products were over-evaluated, and the generic drug consistency evaluation Next article: No.
Seven batches of anti-tumor drugs are forecasted! Over 4 billion marketPrevious article: Looking forward to 2022, which segments of the pharmaceutical and biological sector have great potential? [Information Search] [Add to Favorites] [Tell a friend] [Print this article] [Close the window] Similar information