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On February 15, 2022, the State Food and Drug Administration issued a circular (No.
9, 2022) on the release of the catalogue of generic drug reference preparations (the 50th batch)
.
According to the 54th batch of generic drug reference preparations, there are 54 drugs in total, and the varieties of Novartis, AbbVie, Pfizer and many other large pharmaceutical companies are included in the list of generic drug reference preparations this time
.
Among the 54 drugs, there are 6 domestically marketed original research drugs such as cefbiproxil sodium for injection, loteprednol tobramycin eye drops, anidulafungin for injection, deferasirox granules, upa 37 unimported original research drugs, including tinib sustained-release tablets, lanreotide acetate sustained-release injection (pre-filled), roxatidine hydrochloride acetate sustained-release granules, and pediatric cephalexin compound granules
.
The author has learned that among the 6 domestically marketed original research drugs, there are many varieties that have attracted much attention in the industry and are relatively familiar, such as Basilea's cefbiproxil sodium for injection
.
This variety is a cephalosporin for intravenous injection.
It was jointly developed by Basilea and Johnson & Johnson.
It has rapid and broad-spectrum antibacterial activity and has inhibitory effects on a variety of gram-negative and gram-positive bacteria.
Including methicillin-sensitive and resistant Staphylococcus aureus (MSSA, MRSA) and vancomycin-resistant Staphylococcus aureus (VISA) and vancomycin-resistant Staphylococcus aureus (VRSA), etc.
It is mainly used to treat community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP) in adult patients, but does not include ventilator-associated pneumonia (VAP)
.
According to the data, on September 28, 2017, Shenzhen China Resources Jiuxin Pharmaceutical Co.
, Ltd.
and Basilea signed a technology licensing cooperation agreement on cefbirol.
Development, production and commercialization licenses in Mainland China, Hong Kong, China and Macau, China
.
It is reported that the product has been approved for marketing in the EU, Australia, China and other countries or regions for the treatment of adult hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP) and community-acquired bacterial pneumonia Pneumonia (CABP)
.
The remarks of the document show that the selection of unimported reference preparations to carry out generic drug research not only meets its quality requirements, but also needs to meet the requirements of the current version of the Chinese Pharmacopoeia and related guidelines
.
In addition, after the catalogue of reference preparations is publicized, special research will be conducted on the varieties that have not been officially released, and will be released separately according to the research results
.
According to the public information of the State Food and Drug Administration, since the beginning of this year, the catalogue of generic drug reference preparations has been published for two rounds.
On January 7, 2022, the catalogue of generic drug reference preparations (the 50th batch) was released, and a total of 70 varieties were included.
Among them
.
In addition, according to incomplete statistics in the industry, up to now, a total of 4,858 reference preparations in all 51 batches of catalogs have been released
.
Reference preparation refers to the reference drug used in the development of generic drugs, which is one of the key factors in the process of generic drug development and an important condition for effective generic drug development and consistency evaluation
.
It is understood that since 2016, China has released a total of 51 batches of chemical generic drug reference preparation catalogues.
The release and implementation of relevant policies for the selection of chemical generic drug reference preparations and the catalogue have effectively promoted the consistency evaluation of chemical generic drugs in China.
The process has also laid a solid foundation for the scientific supervision of drug safety and effectiveness
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
9, 2022) on the release of the catalogue of generic drug reference preparations (the 50th batch)
.
According to the 54th batch of generic drug reference preparations, there are 54 drugs in total, and the varieties of Novartis, AbbVie, Pfizer and many other large pharmaceutical companies are included in the list of generic drug reference preparations this time
.
Among the 54 drugs, there are 6 domestically marketed original research drugs such as cefbiproxil sodium for injection, loteprednol tobramycin eye drops, anidulafungin for injection, deferasirox granules, upa 37 unimported original research drugs, including tinib sustained-release tablets, lanreotide acetate sustained-release injection (pre-filled), roxatidine hydrochloride acetate sustained-release granules, and pediatric cephalexin compound granules
.
The author has learned that among the 6 domestically marketed original research drugs, there are many varieties that have attracted much attention in the industry and are relatively familiar, such as Basilea's cefbiproxil sodium for injection
.
This variety is a cephalosporin for intravenous injection.
It was jointly developed by Basilea and Johnson & Johnson.
It has rapid and broad-spectrum antibacterial activity and has inhibitory effects on a variety of gram-negative and gram-positive bacteria.
Including methicillin-sensitive and resistant Staphylococcus aureus (MSSA, MRSA) and vancomycin-resistant Staphylococcus aureus (VISA) and vancomycin-resistant Staphylococcus aureus (VRSA), etc.
It is mainly used to treat community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP) in adult patients, but does not include ventilator-associated pneumonia (VAP)
.
According to the data, on September 28, 2017, Shenzhen China Resources Jiuxin Pharmaceutical Co.
, Ltd.
and Basilea signed a technology licensing cooperation agreement on cefbirol.
Development, production and commercialization licenses in Mainland China, Hong Kong, China and Macau, China
.
It is reported that the product has been approved for marketing in the EU, Australia, China and other countries or regions for the treatment of adult hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP) and community-acquired bacterial pneumonia Pneumonia (CABP)
.
The remarks of the document show that the selection of unimported reference preparations to carry out generic drug research not only meets its quality requirements, but also needs to meet the requirements of the current version of the Chinese Pharmacopoeia and related guidelines
.
In addition, after the catalogue of reference preparations is publicized, special research will be conducted on the varieties that have not been officially released, and will be released separately according to the research results
.
According to the public information of the State Food and Drug Administration, since the beginning of this year, the catalogue of generic drug reference preparations has been published for two rounds.
On January 7, 2022, the catalogue of generic drug reference preparations (the 50th batch) was released, and a total of 70 varieties were included.
Among them
.
In addition, according to incomplete statistics in the industry, up to now, a total of 4,858 reference preparations in all 51 batches of catalogs have been released
.
Reference preparation refers to the reference drug used in the development of generic drugs, which is one of the key factors in the process of generic drug development and an important condition for effective generic drug development and consistency evaluation
.
It is understood that since 2016, China has released a total of 51 batches of chemical generic drug reference preparation catalogues.
The release and implementation of relevant policies for the selection of chemical generic drug reference preparations and the catalogue have effectively promoted the consistency evaluation of chemical generic drugs in China.
The process has also laid a solid foundation for the scientific supervision of drug safety and effectiveness
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
