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On May 10, Renhe Pharmaceutical issued an announcement stating that recently, Jiangxi Pharmaceutical, a subsidiary of the company, received the "Drug Supplementary Application Approval Document" for Gliclazide sustained-release tablets approved and issued by the State Food and Drug Administrati.
Quality and efficacy consistency evaluati.
Gliclazide sustained-release tablet is a second-generation sulfonylurea drug, which is used as an oral diabetes treatment dr.
It is mainly used for non-islet-dependent diabetes mellitus when dietary therapy alone is not enough to control blood sug.
between butylcarbamide and euglycem.
The original manufacturer of this variety is LesLaboratoiresServier from Fran.
The company's sales revenue of this product in 2021 is 27286 million yu.
On May 10, Buchang Pharmaceutical announced that the company's holding subsidiary, Qionglai Tianyin Pharmaceutical, received the "Approval Notice for Supplementary Drug Application" issued by the State Food and Drug Administration for Clindamycin Hydrochloride Capsul.
The drug passed the generic drug quality and efficacy consistency evaluation of the process prescription chan.
The announcement shows that clindamycin is suitable for serious infections caused by sensitive strains such as streptococcus, pneumococcus and staphylococcus, but only for patients who are allergic to penicillin or who have been judged by a doctor to be inappropriate to use penicill.
According to the data of Minet, the annual sales of this product in China (urban public, urban community, county-level public, and township health) from 2019 to 2021 were RMB 555 million, RMB 251 million, and RMB 22 million, respective.
Up to now, the company has invested about 9436 million yuan in the research and development of the drug consistency evaluati.
Lisheng Pharmaceutical announced at noon on May 5 that recently, the company received the "Approval Notice for Supplementary Drug Application" issued by the State Food and Drug Administration for Donepezil Hydrochloride Tablets 5mg, which passed the quality and efficacy consistency evaluation of generic dru.
The announcement shows that the indications of donepezil hydrochloride tablets involve the treatment of mild, moderate or severe Alzheimer's disease sympto.
Lisheng Pharmaceutical stated that the company's over-review of the drug is conducive to enhancing the market competitiveness of the drug
In addition, the recently reviewed generic drugs include Teyi Pharmaceutical's aluminum magnesium carbonate chewable tablets, Jianyou's enoxaparin sodium injection, Sinopharm Hyundai's acyclovir for injection (25g), China Resources Shuanghe's hydrochloric acid Lincomycin Injection, Harbin Pharmaceutical Group's Cefradine Capsules, and Qilu Pharmaceutical's Tofacitinib Citrate Sustained-Release Tablets, Cefprozil Tablets, Oseltamivir Phosphate Capsules, e.
, according to industry statistics, only in April 2022 There are 144 approvals passed/deemed to pass the consistency evaluation, involving 84 varieties of 93 enterprises, of which 16 varieties have been evaluated by the first o.
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 dr.
In recent years, it has become a trend for generic drug consistency evaluation and evaluation of varieties to be purchased with quanti.
In this context, pharmaceutical companies are actively promoting the consistency evaluation of the quality and efficacy of generic drugs to help the future market sales of drugs and enhance market competiti.
, and accumulated valuable experience for the follow-up of generic drug consistency evaluati.
According to the "14th Five-Year Plan for National Drug Safety and Promotion of High-Quality Development" released on December 30, 2021, during the "13th Five-Year Plan" period, China has published a total of 3,963 product specifications in the reference preparation catalogue, and passed the consistency evaluation applicati.
964 pieces of 278 varieti.
It is reported that during the "14th Five-Year Plan" period, China will continue to promote the consistency evaluation of the quality and efficacy of generic dru.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
Quality and efficacy consistency evaluati.
Gliclazide sustained-release tablet is a second-generation sulfonylurea drug, which is used as an oral diabetes treatment dr.
It is mainly used for non-islet-dependent diabetes mellitus when dietary therapy alone is not enough to control blood sug.
between butylcarbamide and euglycem.
The original manufacturer of this variety is LesLaboratoiresServier from Fran.
The company's sales revenue of this product in 2021 is 27286 million yu.
On May 10, Buchang Pharmaceutical announced that the company's holding subsidiary, Qionglai Tianyin Pharmaceutical, received the "Approval Notice for Supplementary Drug Application" issued by the State Food and Drug Administration for Clindamycin Hydrochloride Capsul.
The drug passed the generic drug quality and efficacy consistency evaluation of the process prescription chan.
The announcement shows that clindamycin is suitable for serious infections caused by sensitive strains such as streptococcus, pneumococcus and staphylococcus, but only for patients who are allergic to penicillin or who have been judged by a doctor to be inappropriate to use penicill.
According to the data of Minet, the annual sales of this product in China (urban public, urban community, county-level public, and township health) from 2019 to 2021 were RMB 555 million, RMB 251 million, and RMB 22 million, respective.
Up to now, the company has invested about 9436 million yuan in the research and development of the drug consistency evaluati.
Lisheng Pharmaceutical announced at noon on May 5 that recently, the company received the "Approval Notice for Supplementary Drug Application" issued by the State Food and Drug Administration for Donepezil Hydrochloride Tablets 5mg, which passed the quality and efficacy consistency evaluation of generic dru.
The announcement shows that the indications of donepezil hydrochloride tablets involve the treatment of mild, moderate or severe Alzheimer's disease sympto.
Lisheng Pharmaceutical stated that the company's over-review of the drug is conducive to enhancing the market competitiveness of the drug
In addition, the recently reviewed generic drugs include Teyi Pharmaceutical's aluminum magnesium carbonate chewable tablets, Jianyou's enoxaparin sodium injection, Sinopharm Hyundai's acyclovir for injection (25g), China Resources Shuanghe's hydrochloric acid Lincomycin Injection, Harbin Pharmaceutical Group's Cefradine Capsules, and Qilu Pharmaceutical's Tofacitinib Citrate Sustained-Release Tablets, Cefprozil Tablets, Oseltamivir Phosphate Capsules, e.
, according to industry statistics, only in April 2022 There are 144 approvals passed/deemed to pass the consistency evaluation, involving 84 varieties of 93 enterprises, of which 16 varieties have been evaluated by the first o.
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 dr.
In recent years, it has become a trend for generic drug consistency evaluation and evaluation of varieties to be purchased with quanti.
In this context, pharmaceutical companies are actively promoting the consistency evaluation of the quality and efficacy of generic drugs to help the future market sales of drugs and enhance market competiti.
, and accumulated valuable experience for the follow-up of generic drug consistency evaluati.
According to the "14th Five-Year Plan for National Drug Safety and Promotion of High-Quality Development" released on December 30, 2021, during the "13th Five-Year Plan" period, China has published a total of 3,963 product specifications in the reference preparation catalogue, and passed the consistency evaluation applicati.
964 pieces of 278 varieti.
It is reported that during the "14th Five-Year Plan" period, China will continue to promote the consistency evaluation of the quality and efficacy of generic dru.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
