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Passing the quality and efficacy consistency evaluation of generic drugs means that the national drug regulatory authorities have recognized the company's R&D, production comprehensive capabilities and product quality, which is conducive to accumulating experience for the company's follow-up consistency evaluation of other generic drugs, thereby improving the company's market competitiveness
.
The progress of drug review has always attracted the attention of the industry.
What varieties have been reviewed recently? Peking University Pharmaceuticals: Compound Sulfamethoxazole Tablets Reviewed Peking University Pharmaceuticals announced on the evening of April 15 that the company recently received the “Approval Notice for Supplementary Drug Application” approved and issued by the State Food and Drug Administration, and the company’s declared “Compound Sulfamethoxazole Tablets” (Specification: Sulfamethoxazole 0.
4g, Trimethoprim 80mg)" passed the quality and efficacy consistency evaluation of generic drugs
.
According to the data, compound sulfamethoxazole is a compound preparation of sulfamethoxazole (SMZ) and trimethoprim (TMP), and it is the representative of clinical sulfa drugs
.
Indications are for urinary tract infections caused by sensitive strains of Escherichia coli, Klebsiella, Enterobacter, Proteus mirabilis, Proteus vulgaris and Morganella
.
North China Pharmaceutical: Over-evaluation of Cefotaxime Sodium for Injection Recently, "Cefotaxime Sodium for Injection (0.
5g/1.
0g/2.
0g)" of Hebei Huamin Pharmaceutical of North China Pharmaceutical was approved by the Drug Evaluation Center of the State Food and Drug Administration.
Through the consistency evaluation of the quality and efficacy of generic drugs, the approval has been obtained
.
It is reported that cefotaxime sodium for injection is suitable for pneumonia and other lower respiratory tract infections caused by sensitive bacteria, urinary tract infections, meningitis, sepsis, abdominal infections, pelvic infections, skin and soft tissue infections, reproductive tract infections, bone and joint infections, etc.
.
Yiling Pharmaceutical: Over-evaluation of two varieties On April 12, Yiling Pharmaceutical announced that the company had received the "Approval Notice for Supplementary Drug Application" approved and issued by the State Food and Drug Administration.
Both quinone tablets passed the quality and efficacy consistency evaluation of generic drugs
.
Among them, tinidazole tablet is an anti-inflammatory drug used for various anaerobic infections, such as sepsis, osteomyelitis, abdominal infection, pelvic infection, pulmonary bronchial infection, pneumonia, sinusitis, skin cellulitis, periodontal infection and postoperative wound infection
.
Gliquidone tablet belongs to the second-generation oral sulfonylurea hypoglycemic drug, which is a highly active islet β-cell-friendly agent.
It binds to specific receptors on the pancreatic β-cell membrane and can induce the production of an appropriate amount of insulin to reduce the blood sugar concentration
.
It is worth mentioning that Tinidazole Tablets and Gliquidone Tablets are Class A varieties of the National Medical Insurance List (2021 Edition) and are included in the National Essential Medicines List (2018 Edition)
.
Sailong Pharmaceutical: Two varieties have been evaluated.
Sailong Pharmaceutical also announced a few days ago that Hunan Sailong Pharmaceutical, a wholly-owned subsidiary of the company, has recently obtained the approval and issuance of tigecycline for injection and thymus method for injection by the State Food and Drug Administration.
The new "Approval Notice for Supplementary Drug Application"
.
Tigecycline for injection and thymosin for injection passed the consistency evaluation of the quality and efficacy of generic drugs
.
The announcement shows that tigecycline for injection is an anti-infective drug, which is mainly suitable for infections caused by sensitive strains of specific bacteria in patients aged 18 and over under the following conditions
.
At the same time, for infections for which no other drugs are available, after discussion with an experienced infectious disease physician or clinician, this drug is also suitable for the treatment of infections in children 8 years of age and older caused by sensitive strains of specific bacteria
.
Thymosin for injection is an immunomodulator, suitable for chronic hepatitis B, and can be used as a vaccine immune response enhancer for immunocompromised patients
.
According to incomplete statistics in the industry, from April 10, 2022 to April 16, 2022 alone, the number of new (deemed) over-rated varieties in one week has reached 42 varieties, of which 10 are the first over-rated varieties in the country , including Yumankun's Piracetam Injection, Huachen Pharmaceutical's Arginine Ibuprofen Granules, Lanno Pharmaceutical's Lacosamide Oral Solution, Yangzijiang's Shugeng Glucose Injection,
etc.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
The progress of drug review has always attracted the attention of the industry.
What varieties have been reviewed recently? Peking University Pharmaceuticals: Compound Sulfamethoxazole Tablets Reviewed Peking University Pharmaceuticals announced on the evening of April 15 that the company recently received the “Approval Notice for Supplementary Drug Application” approved and issued by the State Food and Drug Administration, and the company’s declared “Compound Sulfamethoxazole Tablets” (Specification: Sulfamethoxazole 0.
4g, Trimethoprim 80mg)" passed the quality and efficacy consistency evaluation of generic drugs
.
According to the data, compound sulfamethoxazole is a compound preparation of sulfamethoxazole (SMZ) and trimethoprim (TMP), and it is the representative of clinical sulfa drugs
.
Indications are for urinary tract infections caused by sensitive strains of Escherichia coli, Klebsiella, Enterobacter, Proteus mirabilis, Proteus vulgaris and Morganella
.
North China Pharmaceutical: Over-evaluation of Cefotaxime Sodium for Injection Recently, "Cefotaxime Sodium for Injection (0.
5g/1.
0g/2.
0g)" of Hebei Huamin Pharmaceutical of North China Pharmaceutical was approved by the Drug Evaluation Center of the State Food and Drug Administration.
Through the consistency evaluation of the quality and efficacy of generic drugs, the approval has been obtained
.
It is reported that cefotaxime sodium for injection is suitable for pneumonia and other lower respiratory tract infections caused by sensitive bacteria, urinary tract infections, meningitis, sepsis, abdominal infections, pelvic infections, skin and soft tissue infections, reproductive tract infections, bone and joint infections, etc.
.
Yiling Pharmaceutical: Over-evaluation of two varieties On April 12, Yiling Pharmaceutical announced that the company had received the "Approval Notice for Supplementary Drug Application" approved and issued by the State Food and Drug Administration.
Both quinone tablets passed the quality and efficacy consistency evaluation of generic drugs
.
Among them, tinidazole tablet is an anti-inflammatory drug used for various anaerobic infections, such as sepsis, osteomyelitis, abdominal infection, pelvic infection, pulmonary bronchial infection, pneumonia, sinusitis, skin cellulitis, periodontal infection and postoperative wound infection
.
Gliquidone tablet belongs to the second-generation oral sulfonylurea hypoglycemic drug, which is a highly active islet β-cell-friendly agent.
It binds to specific receptors on the pancreatic β-cell membrane and can induce the production of an appropriate amount of insulin to reduce the blood sugar concentration
.
It is worth mentioning that Tinidazole Tablets and Gliquidone Tablets are Class A varieties of the National Medical Insurance List (2021 Edition) and are included in the National Essential Medicines List (2018 Edition)
.
Sailong Pharmaceutical: Two varieties have been evaluated.
Sailong Pharmaceutical also announced a few days ago that Hunan Sailong Pharmaceutical, a wholly-owned subsidiary of the company, has recently obtained the approval and issuance of tigecycline for injection and thymus method for injection by the State Food and Drug Administration.
The new "Approval Notice for Supplementary Drug Application"
.
Tigecycline for injection and thymosin for injection passed the consistency evaluation of the quality and efficacy of generic drugs
.
The announcement shows that tigecycline for injection is an anti-infective drug, which is mainly suitable for infections caused by sensitive strains of specific bacteria in patients aged 18 and over under the following conditions
.
At the same time, for infections for which no other drugs are available, after discussion with an experienced infectious disease physician or clinician, this drug is also suitable for the treatment of infections in children 8 years of age and older caused by sensitive strains of specific bacteria
.
Thymosin for injection is an immunomodulator, suitable for chronic hepatitis B, and can be used as a vaccine immune response enhancer for immunocompromised patients
.
According to incomplete statistics in the industry, from April 10, 2022 to April 16, 2022 alone, the number of new (deemed) over-rated varieties in one week has reached 42 varieties, of which 10 are the first over-rated varieties in the country , including Yumankun's Piracetam Injection, Huachen Pharmaceutical's Arginine Ibuprofen Granules, Lanno Pharmaceutical's Lacosamide Oral Solution, Yangzijiang's Shugeng Glucose Injection,
etc.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
