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On September 9th, Shuangju Pharmaceuticals announced that it had recently received approval from the State Drug Administration to issue a "Drug Supplemental Application Approval Notice" on "Tymoazamine Capsules" (20mg), and that the Company had evaluated the quality and efficacy of the generic drug capsules (20mg) through generic drugs.
announcement, the company obtained a drug registration approval in December 2011 for the pharmaceutical industry's 20mg capsule, which is a Category B product in the National Health Insurance Directory.
application for the conformity evaluation of the variety was accepted by the National Drug Review Center on August 23, 2018.
pharmaceutical company disclosed on September 1, 2020 that it had obtained a drug registration certificate for the thymosamine capsule (100mg) (as if it had passed a consistency evaluation).
Tytoxamide is clinically used for the treatment of newly diagnosed polymorphic glioblastoma and polymorphic glioblastoma or mesozoic astrocyte tumors that relapse or progress after routine treatment, is a first-line treatment drug for cerebral glioma, recommended for the 2012 and 2015 editions of the Guidelines for diagnosis and treatment of gliomas in the central nervous system of China.
In addition, tymoamine has been included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Central Nervous System Tumors, The Chinese Guidelines for the Diagnosis and Treatment of Gliomas (2018 Edition), the China Melanoma Guidelines (2019 Edition), and the Consensus of Experts in the Diagnosis and Treatment of Lung Cancer Brain Metastasis in China (2017 edition).
At present, the domestic temoxamine capsules include the original research only three approved for listing, respectively, the United States Merca East Company's "Tai Dao", Jiangsu Tianshili Diyi Pharmaceutical Co., Ltd. "Tiqing" and Beijing Shuangyi Pharmaceutical Co., Ltd. "Yining."
2019 Pharmaceutical Rubik's Cube 758 sample hospital CPT data, in 2019 the company's tymoamine (20mg, sales revenue of 113 million yuan) accounted for about 6.06% of the market share, days ShiliTiyi Pharmaceuticals (5mg, 20mg, 50mg, 100mg) accounted for approximately 52.94 per cent and Summerton (20mg, 100mg) approximately 40.79 per cent.
this approval will enable the two specifications of tymoamine 20mg and 100mg to pass the consistent evaluation.
source: Shuangli Pharmaceuticals Announcement