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[Pharmaceutical Network Industry News] Generic drug consistency evaluation refers to the quality consistency evaluation of the approved generic drugs in stages and batches according to the principle of consistency with the quality and efficacy of the original drug
.
The "14th Five-Year Plan for National Drug Safety and Promotion of High-Quality Development" shows that during the "13th Five-Year Plan" period, China has solidly promoted the quality and efficacy consistency evaluation of generic drugs, published 3,963 product specifications in the reference preparation catalogue, and passed the consensus Sexual evaluation applied for 964 pieces of 278 varieties
.
During the "14th Five-Year Plan" period, the quality and efficacy consistency evaluation of generic drugs will continue to be promoted
.
With the normalization of centralized procurement, over-evaluation is more like a "ticket" for drugs to participate in centralized procurement, attracting companies to actively deploy
.
Since the beginning of this year, domestic pharmaceutical companies have accelerated the evaluation of the quality and efficacy of generic drugs, and news of over-evaluation has continued to come .
Among them, Huahai Pharmaceutical Co.
On August 10, information from the State Food and Drug Administration showed that Huahai Pharmaceutical's 4 types of generic drugs duloxetine hydrochloride enteric-coated capsules and sitagliptin phosphate tablets were approved for production and were deemed to be over-evaluated .
According to data from Minet.
com, the sales of these two drugs in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) will exceed 900 million yuan and 1.
8 billion yuan respectively in 2021 .
On July 29, information from the State Food and Drug Administration showed that Huahai Pharmaceutical's 4 types of generic valsartan and hydrochlorothiazide tablets for the treatment of mild to moderate essential hypertension whose blood pressure cannot be adequately controlled by a single drug was approved .
According to statistics from Minet.
com, the domestic sales of valsartan and hydrochlorothiazide tablets in 2021 will be approximately RMB 1.
269 billion .
On July 7, oseltamivir phosphate capsules, a class 4 generic drug product of Huahai Pharmaceutical, were approved for marketing.
The drug is mainly used for the treatment of influenza A and B in adults and children over 1 Seltamivir is effective in the treatment of influenza A and B, but there are few clinical data on influenza B); prevention of influenza A and B in adults and adolescents 13 years and older
.
Statistics estimate that in 2021, the domestic sales of oseltamivir phosphate capsules will be about 351 million yuan
.
On July 5, Huahai Pharmaceutical's Linagliptin tablets were approved for marketing.
At the same time, since the drug was approved for production in accordance with Category 4 of chemical drugs, it was deemed to have passed the consistency evaluation of generic drugs
.
Linagliptin tablets are mainly used for the treatment of type 2 diabetes to improve blood sugar control
.
According to statistics from Minet.
com, the domestic sales of linagliptin tablets in 2021 will be approximately RMB 787 million
.
In addition, in the first half of this year, Huahai Pharmaceutical also has 4 types of generic drugs approved, including Valsartan Hydrochlorothiazide Tablets, Apixaban Tablets, and Levetiracetam Injection Concentrated Solution, which are deemed to have passed the consistency evaluation of generic drugs
.
Judging from the 8 generic drug treatment categories that Huahai Pharmaceutical has approved since this year, they mainly involve the fields of psychoneurology, metabolism, cardiovascular and cerebrovascular, and anti-infection.
After these varieties have been approved and reviewed, they will help further enrich the company's product pipeline
.
Among them, Oseltamivir Phosphate Capsules was approved for marketing on July 7, and successfully participated in the seventh batch of centralized collection to obtain the qualification for selection
.
Up to now, 38 varieties of Huahai Pharmaceutical have passed/deemed to have passed the consistency evaluation.
In the first six batches of centralized procurement of chemical drugs, the company has selected as many as 18 varieties
.
As more varieties are reviewed, it may prepare for pharmaceutical companies to participate in the next round of centralized procurement
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
The "14th Five-Year Plan for National Drug Safety and Promotion of High-Quality Development" shows that during the "13th Five-Year Plan" period, China has solidly promoted the quality and efficacy consistency evaluation of generic drugs, published 3,963 product specifications in the reference preparation catalogue, and passed the consensus Sexual evaluation applied for 964 pieces of 278 varieties
.
During the "14th Five-Year Plan" period, the quality and efficacy consistency evaluation of generic drugs will continue to be promoted
.
With the normalization of centralized procurement, over-evaluation is more like a "ticket" for drugs to participate in centralized procurement, attracting companies to actively deploy
.
Since the beginning of this year, domestic pharmaceutical companies have accelerated the evaluation of the quality and efficacy of generic drugs, and news of over-evaluation has continued to come .
Among them, Huahai Pharmaceutical Co.
On August 10, information from the State Food and Drug Administration showed that Huahai Pharmaceutical's 4 types of generic drugs duloxetine hydrochloride enteric-coated capsules and sitagliptin phosphate tablets were approved for production and were deemed to be over-evaluated .
According to data from Minet.
com, the sales of these two drugs in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) will exceed 900 million yuan and 1.
8 billion yuan respectively in 2021 .
On July 29, information from the State Food and Drug Administration showed that Huahai Pharmaceutical's 4 types of generic valsartan and hydrochlorothiazide tablets for the treatment of mild to moderate essential hypertension whose blood pressure cannot be adequately controlled by a single drug was approved .
According to statistics from Minet.
com, the domestic sales of valsartan and hydrochlorothiazide tablets in 2021 will be approximately RMB 1.
269 billion .
On July 7, oseltamivir phosphate capsules, a class 4 generic drug product of Huahai Pharmaceutical, were approved for marketing.
The drug is mainly used for the treatment of influenza A and B in adults and children over 1 Seltamivir is effective in the treatment of influenza A and B, but there are few clinical data on influenza B); prevention of influenza A and B in adults and adolescents 13 years and older
.
Statistics estimate that in 2021, the domestic sales of oseltamivir phosphate capsules will be about 351 million yuan
.
On July 5, Huahai Pharmaceutical's Linagliptin tablets were approved for marketing.
At the same time, since the drug was approved for production in accordance with Category 4 of chemical drugs, it was deemed to have passed the consistency evaluation of generic drugs
.
Linagliptin tablets are mainly used for the treatment of type 2 diabetes to improve blood sugar control
.
According to statistics from Minet.
com, the domestic sales of linagliptin tablets in 2021 will be approximately RMB 787 million
.
In addition, in the first half of this year, Huahai Pharmaceutical also has 4 types of generic drugs approved, including Valsartan Hydrochlorothiazide Tablets, Apixaban Tablets, and Levetiracetam Injection Concentrated Solution, which are deemed to have passed the consistency evaluation of generic drugs
.
Judging from the 8 generic drug treatment categories that Huahai Pharmaceutical has approved since this year, they mainly involve the fields of psychoneurology, metabolism, cardiovascular and cerebrovascular, and anti-infection.
After these varieties have been approved and reviewed, they will help further enrich the company's product pipeline
.
Among them, Oseltamivir Phosphate Capsules was approved for marketing on July 7, and successfully participated in the seventh batch of centralized collection to obtain the qualification for selection
.
Up to now, 38 varieties of Huahai Pharmaceutical have passed/deemed to have passed the consistency evaluation.
In the first six batches of centralized procurement of chemical drugs, the company has selected as many as 18 varieties
.
As more varieties are reviewed, it may prepare for pharmaceutical companies to participate in the next round of centralized procurement
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
