Zhengda Tianqing and Yangzi River two hundred million varieties of amlodipine

As of October 31, the acceptance number of CDE acceptance consistency evaluation reached 1543 (428 varieties of 442 enterprises) According to the supplementary application, the same below); 270 (111 varieties) have been evaluated and accepted This week (from October 24 to October 31), 4 varieties had been evaluated; 6 varieties had been approved, and the 12th enterprise of amlodipine had been evaluated; 14 varieties had been undertaken, and 18.5 billion calm and sleeping markets were ready for the troublemakers Four drugs passed the consistency evaluation this week, two of which were the first to pass Details of consistency assessment passed this week Candesartan dipivoxil is an antagonist of angiotension II receptor, which is used to treat essential hypertension Developed by Takeda, Japan, and subsequently cooperated with AstraZeneca Pharmaceutical Co., Ltd in the joint development and promotion of the global market In December 1997, candesartan ester was listed in Sweden for the first time, and was put on the U.S market after the approval of the U.S FDA in 1998, which promoted the global market development process of candesartan ester At present, 12 domestic enterprises produce candesartan ester tablets, including Chongqing Shenghua Xi, Hunan Tiandi Hengyi pharmaceutical, Zhejiang Yongning pharmaceutical, Guangzhou Baiyunshan Tianxin pharmaceutical In 2018, the sales volume of domestic sample hospitals was 146 million yuan, and Chongqing Shenghua Xi accounted for the largest sales volume of sample hospitals, 37.72% According to the pharmaceutical intelligence data, at present, only three enterprises have applied for the consistency evaluation of candesartan ester tablets, all of which have been evaluated so far It is worth mentioning that Tiandi Hengyi Pharmaceutical Co., Ltd., which has been evaluated this week, although it is the third enterprise that has been evaluated for this product, is the second enterprise that has passed the 4mg product specification Details of consistency evaluation of candesartan tablets Ibuprofen is a kind of non steroidal anti-inflammatory drug, which is mainly used to relieve moderate pain, such as joint pain, neuralgia, muscle pain, migraine, headache, toothache, and also to reduce the fever caused by common cold or influenza After 10 years of research, Dr Stewart Adams (Stewart Adams) of the UK succeeded in research and development in 1962, and was first approved for listing in the UK in 1969 Ibuprofen granules are class a over-the-counter drugs in China, and are also included in the new version of the national health insurance catalog and the basic drug catalog At present, it is widely used in hospitals at all levels and grass-roots medical institutions According to the hospital sales data of pharmaceutical intelligence data Enterprise Edition, 70% of the market volume of ibuprofen granule domestic sample hospitals is occupied by Harbin Pharmaceutical Group, followed by SINOSURE, accounting for 17.73% At present, there are 15 market approvals for domestic ibuprofen granules, involving 10 manufacturers, among which 6 enterprises apply for conformity evaluation and the first application of Sinopharm Europe Italy At present, it has been in the state of "certificate preparation completed - approval to be issued" However, it is overtaken by the Yangtze River bend near the end point, taking the first one, and will enjoy the national dividend preferentially Lenalidomide capsule Lenalidomide is a synthetic derivative of glutamic acid, a thalidomide analogue, a new generation of immunomodulator with immunomodulatory, anti angiogenic and anti-tumor properties It is widely used in the treatment of multiple myeloma, lymphoma, myelodysplastic syndrome, acute myeloid leukemia and other diseases It is currently the international and domestic treatment of multiple myeloma and bone Commonly used drugs for myelodysplastic syndromes Renapamil, the original research drug of renapamil, was approved by FDA in December 2005, and approved by China in 2013 In 2017, renapamil ranked first among the best-selling anti-tumor drugs in the world According to the sales data of drug intelligence hospital, the sales volume of domestic sample hospitals of renapamil capsule reached 2 in 2018, 5.7583 million yuan, 96.78% of which was occupied by the original research enterprises, and 3.22% by Beijing Shuanglu pharmaceutical, the first imitator Up to now, there are only three domestic manufacturers of lenalidomide capsule, namely, Zhengda Tianqing, Qilu pharmaceutical and Beijing Shuanglu pharmaceutical Among them, Beijing Shuanglu pharmaceutical is the first generic drug of the product, and its consistency evaluation is still in the review and approval stage Qilu pharmaceutical was approved in April this year according to 6 categories of new chemicals registration, which is deemed to have passed the consistency evaluation Now, Zhengda Tianqing has applied for the evaluation according to the supplementary application, which is in good order Li became the second evaluated enterprise We will join the team to challenge the original research and strive to replace the original research drug The second generation of cefaclor capsule is mainly suitable for respiratory system, urinary system, otorhinolaryngology, skin and soft tissue infection caused by sensitive bacteria Developed by Lilly of the United States, it was first listed in 1985 with the trade name of "hickory"; it entered China in 1993 In 2018, the sales volume of cefaclor capsule in the domestic sample hospital reached 144 million yuan, a new high in recent three years, among which the original research enterprises still accounted for the highest proportion, accounting for 35.24%, followed by Guangzhou Nanxin pharmaceutical and Suzhou Sinochem, accounting for 26.1% and 22.07% respectively At present, there are only three enterprises applying for the consistency evaluation of this variety Suzhou Sinochem, Guangzhou Nanxin pharmaceutical and Shenzhen Lijian pharmaceutical industry are the first ones to have been evaluated by Suzhou Sinochem to further improve product quality and competitive strength Six drugs have been approved this week, including nilestriol tablets of Shanghai New Hualian Pharmaceutical Co., Ltd and weigliptin tablets of Qilu Pharmaceutical Co., Ltd., which have not been evaluated by enterprises before, meaning that the first evaluated varieties of the two enterprises will be added soon Details of approval of this week's conformity assessment In addition, it should be noted that amlodipine besylate, the most competitive product in the field of consistency evaluation, is about to produce another strong competitor, Yichang dongyangguang Changjiang Pharmaceutical Co., Ltd According to the data of pharmaceutical intelligence, up to now, there are 41 application acceptance numbers of amlodipine besylate tablets, ranking second; 36 enterprises are involved, which is the most variety applied by enterprises; at present, there are 11 enterprises that have evaluated the variety, ranking first in the evaluation list, and Yichang Dongyang guangchangjiang Pharmaceutical Co., Ltd is no surprise that the 12th enterprise will pass the consistency evaluation of amlodipine besylate tablets Recently, in the results of the opening of the bid for the expansion of centralized drug procurement organized by the state, the competition of amlodipine besylate tablets was particularly fierce For the purpose of winning the bid, the price of this product of Chongqing Yaoyou dropped sharply to 0.07 yuan / tablet (5mg) Now Yichang dongyangguang Changjiang Pharmaceutical Co., Ltd has entered the Bureau, and the competition of amlodipine besylate tablets has further increased Details of consistency evaluation of amlodipine besylate tablets This week, CDE added 20 acceptance numbers of consistency evaluation (14 varieties); three of them are the first drugs to be accepted, namely alprazolam tablets of Shandong Xinyi pharmaceutical, vitamin C tablets of Shenyang first pharmaceutical of Northeast Pharmaceutical Group and buguizine hydrochloride tablets For more details, see the table below: Details of acceptance of this week's conformity assessment declaration Note: the red part is the new variety of this week Among them, alprazolam tablets are the focus Alprazolam tablets belong to benzodiazepines, which are mainly used in anxiety, tension, agitation, hypnosis or anxiety auxiliary drugs, as well as anti panic drugs, and can relieve the symptoms of acute alcohol withdrawal It is the top 10 domestic sample hospitals in terms of sedative and hypnotic drugs, and it is worth mentioning that top 10 sedative and hypnotic drugs occupy 99% of the total market of sedative and hypnotic drugs In addition, according to the hospital sales data of pharmaceutical intelligence data Enterprise Edition, from 2016 to 2018, the sales of alprazolam tablets in domestic sample hospitals increased year by year in three years, with the fastest growth rate of 16.65% in 2018 In 2018, the sales volume of domestic sample hospitals of alprazolam tablets reached 372.23 yuan, of which Jiangsu Enhua pharmaceutical industry accounted for the largest proportion, accounting for 30.33%, followed by Beijing Yimin and Qilu pharmaceutical At present, there are 56 market approvals for domestic alprazolam tablets, 55 manufacturers, 7 enterprises with consistency evaluation reference and filing, and only Shandong Xinyi pharmaceutical application has been accepted According to the statistical data of pharmaceutical economic report, the market scale of domestic psychostatic drugs in 2017 reached 18.505 billion yuan; if alprazolam tablets passed the evaluation successfully, it will disrupt the market of 18.5 billion yuan.