Under the influence of factors such as the normalization of collection, the continuous deepening of pharmaceutical reform, and the intensification of market competition, pharmaceutical companies are actively promoting the evaluation of
generic drugs.
According to the data, as of the end of July this year, the total acceptance number of the consistency evaluation of generic drugs has reached 4112, and 2603 acceptance numbers have been passed, and 2205 have
been passed.
In August, 84 new consistency evaluation acceptance numbers were added; 85 approvals (including 62 deemed approved) were evaluated
.
It is worth noting that since September, pharmaceutical companies have remained very positive
in the evaluation.
It is reported that in the past week, a large number of drugs have been evaluated
.
On the medicine Xinyi warfarin sodium tablets have been reviewed
On the medicine Xinyi warfarin sodium tablets have been reviewed
On September 26, Shanghai Pharmaceutical issued an announcement that its holding subsidiary, Shanghai Pharmaceutical Xinyi, received the "Notice of Approval of Drug Supplement Application" issued by the State Food and Drug Administration on warfarin sodium tablets, and the drug passed the consistency evaluation of
generic drugs.
Warfarin sodium tablets are mainly used for the prevention and treatment of thromboembolic complications after deep vein thrombosis (DVT) and pulmonary embolism (PE), atrial fibrillation (AF), and/or heart valve replacement to reduce the risk of
death, recurrence, and thromboembolic events (such as stroke or systemic embolism) after myocardial infarction.
The drug was developed by Bristol-Myers Squibb and was launched
in the United States in 1954.
At present, the main manufacturers of the drug in China have Finland Orion Pharmaceutical Factory, Qilu Pharmaceutical Co.
, Ltd.
and so on
.
It is understood that as of the announcement date, Shanghai Pharmaceutical has invested about 13.
32 million yuan
in research and development costs for the consistency evaluation of the drug.
Northeast Pharmaceutical levonorgestrel tablets have been reviewed
Northeast Pharmaceutical levonorgestrel tablets have been reviewed
On September 25, Northeast Pharmaceutical announced that the company recently received the approval notice of drug supplement application for levonorgestrel tablets approved by the State Drug Administration, and the drug passed the consistency evaluation
of generic quality and efficacy.
It is understood that the drug is suitable for emergency contraception in women, that is, when
there is no protective measure or other contraceptive method accidental mistakes.
Northeast Pharmaceutical said that levonorgestrel tablets successfully passed the consistency evaluation and have the qualification conditions to
participate in the centralized procurement of national drugs.
This move will help enhance the competitiveness of the product market and accumulate experience
for the company's follow-up products to carry out generic drug consistency evaluation.
Lisheng Pharmaceutical hydrochlorothiazide tablets have been reviewed
Lisheng Pharmaceutical hydrochlorothiazide tablets have been reviewed
On September 23, Tianjin Lisheng Pharmaceutical Co.
, Ltd.
announced that it recently received the "Notice of Approval of Drug Supplemental Application" (approval number: 2022B03878) issued by the State Drug Administration on the 25mg specification of hydrochlorothiazide tablets (hereinafter referred to as "the drug"), and the drug passed the consistency evaluation
of generic drug quality and efficacy.
Chinese medicine cefotaxime sodium review
Chinese medicine cefotaxime sodium review
China Pharmaceutical announced on September 23 that GM Sanyo, a wholly-owned subsidiary of the company, received two copies of the "Notice of Approval of Drug Supplement Application for Drug Supplementation" issued by the State Food and Drug Administration for injection of cefotaxime sodium, which passed the consistency evaluation
of generic drug quality and efficacy.
The data show that cefotaxime sodium is a semi-synthetic third-generation cephalosporin antibiotic, which belongs to the β-lactam antibiotic, and has a good antibacterial effect
on gram-negative bacteria and gram-positive bacteria.
As of the date of the announcement, the drug consistency evaluation research and development investment was about 5.
43 million yuan (unaudited
).
Yuekang Pharmaceutical Injection Omeprazole sodium has been reviewed
Yuekang Pharmaceutical Injection Omeprazole sodium has been reviewed
On September 22, Yuekang Pharmaceutical announced that the company recently received the "Notice of Approval of Drug Supplement Application" issued by the State Drug Administration on omeprazole sodium (40mg) for injection, and the drug passed the consistency evaluation
of generic drug quality and efficacy.
It is reported that omeprazole can inhibit gastric acid secretion
by inhibiting the activity of H+-K+-ATPase in gastric parietal cells.
Omeprazole sodium for injection has been used in clinical practice for more than 20 years, and its clinical application is evidence-based, and it has been recommended as one of
the preferred drugs for gastrointestinal ulcers by many guidelines or expert consensus at home and abroad.
The annual sales trend of sample hospitals in China (urban public) in 2021 shows that the sales of omeprazole sodium for injection are 2.
484 billion yuan
.