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[Pharmaceuticals.
com Industry News] Compared with original research drugs, generic drugs have lower R&D costs and looser marketing approval conditions.
In order to improve the high-quality development of generic drugs, the consistency evaluation of generic drugs has been introduced as a threshold for centralized procurement
.
It is understood that since the implementation of the generic drug consistency evaluation policy, many pharmaceutical companies have actively participated in it
.
In May, another pharmaceutical company announced that the drug passed the consistency evaluation of generic drugs
.
Lisheng Pharmaceutical announced at noon on May 5 that recently, the company received the "Approval Notice of Drug Supplementary Application" for Donepezil Hydrochloride Tablets 5mg issued by the State Drug Administration, and the drug passed the consistency evaluation of the quality and efficacy of generic drugs.
.
Lisheng Pharmaceutical stated that the company's drug passed the quality and efficacy consistency evaluation of generic drugs, which is conducive to enhancing the market competitiveness of the drug
.
Data show that donepezil hydrochloride is a second-generation cholinesterase inhibitor, clinically used for the treatment of mild, moderate or severe Alzheimer's disease symptoms
.
It is currently believed that the pathogenesis of Alzheimer's disease dementia symptoms is partly related to the reduction of cholinergic neurotransmission function
.
Donepezil hydrochloride may exert therapeutic effects by enhancing the function of cholinergic nerves
.
It reversibly inhibits the hydrolysis of acetylcholine by acetylcholinesterase, thereby increasing the concentration of acetylcholine
.
Lisheng Pharmaceutical's Donepezil Hydrochloride Tablets (trade name: Fusco) were approved for marketing in 2004.
In 2019, Lisheng Pharmaceutical started the consistency evaluation of Donepezil Hydrochloride Tablets.
The process re-developed the generic preparation, effectively controlled the key quality attributes, and through the stability study, it was shown that the quality of the product in vitro was equivalent to that of the reference preparation; the in vivo evaluation included fasting and postprandial testing in healthy adult subjects Under the conditions of administration, a single-center, open, balanced, randomized, single-dose, double-cycle, double-crossover bioequivalence study showed that the test preparation and reference preparation of oral 5mg Donepezil Hydrochloride Tablets were administered on an empty stomach and after meals are bioequivalent
.
It is understood that Lisheng Pharmaceutical has made every effort to promote the consistency evaluation work.
Up to now, Lisheng Pharmaceutical has passed the consistency evaluation of 12 product regulations, 3 of which are the first in China
.
The author has learned that there are many pharmaceutical companies that have over-reviewed drugs recently.
For example, Teyi Pharmaceutical recently announced that it has recently obtained the “Approval Notice of Drug Supplementary Application” for “Aluminum Magnesium Carbonate Chewable Tablets” approved and issued by the State Drug Administration.
, after review, the above-mentioned drugs have passed the consistency evaluation of chemical generic drug quality and efficacy
.
Jianyou Co.
, Ltd.
also recently issued an announcement saying that the company recently received the approval and issuance of the "Approval Notice for Supplementary Drug Application" from the State Food and Drug Administration
.
Sinopharm Modern also recently issued an announcement stating that its wholly-owned subsidiary Sinopharm Rongsheng has received the “Approval Notice for Supplementary Drug Application” of Acyclovir for Injection (0.
25g) approved and issued by the Food and Drug Administration, approving the drug to pass the quality of generic drugs.
and efficacy consistency evaluation
.
According to statistics, in April, 144 approval documents passed/deemed to pass the consistency evaluation, involving 84 varieties of 93 companies, of which 16 varieties were first reviewed
.
In terms of over-reviewed companies, China Resources Shuanghe, Sichuan Kelun, Yangtze River, Shijiazhuang Siyao, and CSPC Ouyi have all over-reviewed in April
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
com Industry News] Compared with original research drugs, generic drugs have lower R&D costs and looser marketing approval conditions.
In order to improve the high-quality development of generic drugs, the consistency evaluation of generic drugs has been introduced as a threshold for centralized procurement
.
It is understood that since the implementation of the generic drug consistency evaluation policy, many pharmaceutical companies have actively participated in it
.
In May, another pharmaceutical company announced that the drug passed the consistency evaluation of generic drugs
.
Lisheng Pharmaceutical announced at noon on May 5 that recently, the company received the "Approval Notice of Drug Supplementary Application" for Donepezil Hydrochloride Tablets 5mg issued by the State Drug Administration, and the drug passed the consistency evaluation of the quality and efficacy of generic drugs.
.
Lisheng Pharmaceutical stated that the company's drug passed the quality and efficacy consistency evaluation of generic drugs, which is conducive to enhancing the market competitiveness of the drug
.
Data show that donepezil hydrochloride is a second-generation cholinesterase inhibitor, clinically used for the treatment of mild, moderate or severe Alzheimer's disease symptoms
.
It is currently believed that the pathogenesis of Alzheimer's disease dementia symptoms is partly related to the reduction of cholinergic neurotransmission function
.
Donepezil hydrochloride may exert therapeutic effects by enhancing the function of cholinergic nerves
.
It reversibly inhibits the hydrolysis of acetylcholine by acetylcholinesterase, thereby increasing the concentration of acetylcholine
.
Lisheng Pharmaceutical's Donepezil Hydrochloride Tablets (trade name: Fusco) were approved for marketing in 2004.
In 2019, Lisheng Pharmaceutical started the consistency evaluation of Donepezil Hydrochloride Tablets.
The process re-developed the generic preparation, effectively controlled the key quality attributes, and through the stability study, it was shown that the quality of the product in vitro was equivalent to that of the reference preparation; the in vivo evaluation included fasting and postprandial testing in healthy adult subjects Under the conditions of administration, a single-center, open, balanced, randomized, single-dose, double-cycle, double-crossover bioequivalence study showed that the test preparation and reference preparation of oral 5mg Donepezil Hydrochloride Tablets were administered on an empty stomach and after meals are bioequivalent
.
It is understood that Lisheng Pharmaceutical has made every effort to promote the consistency evaluation work.
Up to now, Lisheng Pharmaceutical has passed the consistency evaluation of 12 product regulations, 3 of which are the first in China
.
The author has learned that there are many pharmaceutical companies that have over-reviewed drugs recently.
For example, Teyi Pharmaceutical recently announced that it has recently obtained the “Approval Notice of Drug Supplementary Application” for “Aluminum Magnesium Carbonate Chewable Tablets” approved and issued by the State Drug Administration.
, after review, the above-mentioned drugs have passed the consistency evaluation of chemical generic drug quality and efficacy
.
Jianyou Co.
, Ltd.
also recently issued an announcement saying that the company recently received the approval and issuance of the "Approval Notice for Supplementary Drug Application" from the State Food and Drug Administration
.
Sinopharm Modern also recently issued an announcement stating that its wholly-owned subsidiary Sinopharm Rongsheng has received the “Approval Notice for Supplementary Drug Application” of Acyclovir for Injection (0.
25g) approved and issued by the Food and Drug Administration, approving the drug to pass the quality of generic drugs.
and efficacy consistency evaluation
.
According to statistics, in April, 144 approval documents passed/deemed to pass the consistency evaluation, involving 84 varieties of 93 companies, of which 16 varieties were first reviewed
.
In terms of over-reviewed companies, China Resources Shuanghe, Sichuan Kelun, Yangtze River, Shijiazhuang Siyao, and CSPC Ouyi have all over-reviewed in April
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
