Progress of popular products for consistency evaluation: Amlodipine Besylate tablets, montmorillonite powder, amoxicillin

In July 2018, the State Drug Administration released the list of the fifth batch of approved conformity evaluation varieties, and said that the National Bureau would not announce in batches after that, and the approved varieties would be directly included in the catalogue of Chinese listed drugs, According to the first five catalogues, three manufacturers of tenofovir dipivoxil fumarate tablets, amlodipine besylate, montmorillonite and rosuvastatin calcium tablets have passed the consistency evaluation If there are more than three manufacturers that have passed the consistency evaluation of the same kind of drugs, they will no longer choose the varieties that have failed the consistency evaluation in terms of centralized purchase of drugs Since August 2018, Jiangxi, Zhejiang and Liaoning provinces have announced how drug purchasing agencies can stop purchasing manufacturers that have won the bid but have not passed the consistency evaluation Provinces have started to purchase products through the consistency evaluation online According to a plan on pilot drug centralized procurement organized by the state circulated on the Internet, 11 cities in Shanghai, Tianjin, Chongqing, Shenyang, Dalian, Guangzhou, Shenzhen, Xiamen, Chengdu and Xi'an carried out pilot drug centralized procurement for products passing the consistency evaluation 60% - 70% of the total annual drug consumption of all public medical institutions in the trial area should be purchased through the consistency For the evaluation of generic drugs, medical institutions can purchase other online products for the remaining dosage It is very obvious that the product passing the consistency evaluation is good According to the data of Xianda drug sea travel, two manufacturers, atorvastatin calcium tablets, escitalopram oxalate tablets, irbesartan tablets, irbesartan hydrochlorothiazide tablets, entecavir dispersible tablets, captopril tablets and cefuroxime ester tablets, have passed the consistency evaluation With the increase of the number of manufacturers who have passed the conformity evaluation, the competition is intensified, and the manufacturers are facing the pressure of price reduction For this reason, Xianda pharmaceutical has selected the most popular products and the current market scale of its medical institutions Top 1 (parallel) amlodipine besylate tablets: 9 hospitals with a market scale of more than 5 billion yuan have applied, and all of them have started be research Top 1 (juxtaposed) montmorillonite powder: 9 hospitals with a market scale of more than 300 million yuan apply for it, which belongs to the exempted be product top3 amoxicillin capsule: 8 hospitals with a market scale of more than 200 million yuan apply for it have started the be research TOP4 (juxtaposed) rosuvastatin calcium tablets: Market scale of more than 6 billion yuan apply for it 6, except for imported generic drugs, all have started be research Top 4 (side by side) cefuroxime ester tablets: 6 companies with a market scale of more than 500 million yuan have been declared, and all of them have started be research except for imported generic drugs Top 4 (parallel) metformin hydrochloride tablets: the market scale is more than 3.5 billion yuan Six metformin hydrochloride tablets have been applied for clinical research Five metformin hydrochloride sustained-release tablets have also applied for conformity evaluation Only Shijiazhuang Huaxin Pharmaceutical Co., Ltd has not started clinical trials since 2015 Top7 irbesartan tablets: Huahai and haizhenghuirui have been listed abroad with a market scale of more than 1 billion yuan, exempt be from conformity evaluation Top 8 (side by side) entecavir dispersible tablets / entecavir capsules: the market scale is 9 billion yuan Different dosage forms have different products that pass the consistency Entecavir dispersible tablets of Zhengda Tianqing Pharmaceutical Group Co., Ltd passed the consistency evaluation There is no evaluation conclusion for entecavir capsule of Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd top 8 (juxtaposed) indapamide tablets: there is no consistency evaluation for products with a market scale of 100 million yuan Top 8 (parallel) tenofovir fumarate dipivoxil tablets Market Size 1.2 billion yuan Apply for 4 companies, all of which have started be research Top 8 (parallel) captopril tablets: four captopril tablets with a market scale of RMB 50 million have been declared, all of which have started be research Top 8 (parallel) isoniazid tablets: 250 million yuan is one of the top ten popular products in the summary of exempted be products It can be seen that large sales volume, or no need to start be research, or similar products have been listed in the market, and other manufacturers that export to Europe and the United States have to speed up investment consistency may be the reasons for the popularity of products From the perspective of clinical registration time, the basic applications for launching clinical be in 2017 have been applied for conformity evaluation in 2018 This means that in 2016, the consistency evaluation policy was launched, and 289 products that are willing to be launched have already been launched The completion of the consistency evaluation by the end of 2018 is completely achievable for most products The consistency evaluation policy is more beneficial, and the reason why the enterprise is not willing to start is that the market potential is small, the investment return is poor, and the project is too difficult, and the cost is too large More than half of 2018 has passed, and the acceptance number of application for conformity assessment has not exceeded 500, so the progress of conformity assessment is worrying.