CFDA has generated 110 acceptance numbers for the generic drug consistency evaluation applications accepted by April 2, 2018, involving 51 varieties of 53 pharmaceutical enterprises.

CFDA has previously released the lists of two batches of varieties passing generic drug quality and efficacy evaluation, with 17 varieties of 27 specifications completed approval. According to statistics of insiders for varieties completed approval, the average review duration for generic drug consistency evaluation is about 150 days, the variety with the shortest review duration is the Tenofovir Disoproxil Fumarate Tablets of Chengdu Brilliant Pharmaceutical: 92 days, while the one with the longest review duration was Rosuvastatin Calcium Tablets of Zhejiang Jingxin Pharmaceutical: 234 days.
See the following table for the top 5 varieties in consistency evaluation sorted by the application acceptance number, which are separately Amlodipine Besylate Tablets, Rosuvastatin Calcium Tablets, Irbesartan Tablets, Cefuroxime Axetil Tablets, and Escitalopram Oxalate Tablets.
|
Variety name |
Application acceptance number |
Applicant enterprise |
Enterprise that passes |
Catalog of 289 essential drugs |
|
Amlodipine Besylate Tablets |
7 |
5 |
1 |
Yes |
|
Rosuvastatin Calcium Tablets |
7 |
4 |
2 |
No |
|
Irbesartan Tablets |
5 |
3 |
2 |
No |
|
Cefuroxime Axetil Tablets |
5 |
3 |
1 |
Yes |
|
Escitalopram Oxalate Tablets |
5 |
3 |
1 |
No |
Amlodipine Besylate Tablets
Amlodipine Besylate Tablets is currently the variety with the highest proportion on the calcium antagonist market segment of China, which is about 30.51%. According to data of menet.com, the relevant market size of city public hospitals in China was about RMB 2.919 billion in 2016, wherein, the original drug: Pfizer’s Norvasc accounted for more than 72% market share. There have been 65 approvals for Amlodipine Besylate Tablets in China, and the Chinese enterprise with the highest market share is Yangtze River Pharmaceutical, which is about 4.12%, while the market share of Jiangsu Yellow River Pharmaceutical is less than 1%.
There have been 5 pharmaceutical enterprises filing application for this variety, wherein, Jiangsu Yellow River Pharmaceutical is the first in passing the consistency evaluation, and Yangtze River Pharmaceutical’s application progress is...










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