Consistency evaluation analysis: 95 varieties passed the evaluation, 17 varieties of the first to pass the evaluation
Source: drugwise.com/listening
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January CDE new acceptance number 88 (54 varieties, 53 companies).
150 approvals (including deemed passes) involving 95 varieties were evaluated in January.
According to the Pharmaceutical Intelligence Data Enterprise Edition Consistency Evaluation Analysis System, in January 2022, there were 88 new acceptance numbers for consistency evaluation; 150 approvals (including 57 approvals deemed to have passed) passed the evaluation. (Attached at the end of the article is a table with details of January's declarations and over-evaluation consistency evaluation)
Figure 1 Trend of declarations/passes in July 2021-January 2022
Data source: Pharmaceutical Intelligence Data, compiled by Pharmaceutical Intelligence Consulting
Over-evaluation details
Accumulatively, there were 150 batches passing/deemed to have passed the consistency evaluation in January, involving 95 varieties of 97 enterprises, and 17 of them were the first to pass the evaluation. Among them, 17 varieties were the first to pass evaluation.
From the evaluation of enterprises, in January, Nanjing Zhengda Tianqing, Sinopharm Zhijun (Shenzhen) Pharmaceutical, Ruiyang Pharmaceuticals, Cenxin Pharmaceuticals have three varieties through the consistency evaluation, tied for first. For details, see the chart below
Figure 2 TOP10 of the number of varieties passed by enterprises in January 2022
Data source: Pharmaceutical Intelligence Data, organized by Pharmaceutical Intelligence Consulting
Nanjing Zhoda Tianqing Pharmaceutical Co., Ltd. is a high-tech sino-foreign joint venture founded by Zhoda Pharmaceutical, Jiangsu Nongkeng, Jiangsu Zhoda Tianqing Pharmaceutical, and Lianyungang Jinkang Investment*** together. The company inherits more than 30 years of experience in drug production and quality management of Chengtai Tianqing, relying on the postdoctoral research station, new drug research and development center of a strong R & D platform, through first-class equipment, advanced technology, strict production quality management, to ensure the high level of production, high quality products, and thus honored as one of the first 13 "Drug Quality and Integrity Construction Demonstration Enterprises The company has been honored as one of the first 13 "Model Enterprises for Drug Quality and Integrity Building" in China. Up to now 47 varieties have been declared for consistency evaluation (including the declaration of newly registered classified generic drugs), and 28 varieties have been evaluated.
SINOPHARM Zhijun (Shenzhen) Pharmaceutical Co., Ltd. is located in the export-oriented specialized cephalosporin preparations production base, the domestic production base of high-end preparations, has been awarded the powder injection, oral EU double certification, WHO PQ certification and other international high-standard certification. The company adheres to the quality management concept of "continuous improvement and excellence", continues to promote lean management and performance excellence, and has created a number of brand-name products with top market shares, among which Dalixin and Dalifen have become the leaders of similar products, and the products have entered the mainstream market of the European Union, gradually establishing an international brand. Up to now there are 14 varieties declared consistency evaluation (including the new registration of classified generic drug declaration), of which 8 varieties have been evaluated.
Ruiyang Pharmaceutical Co., Ltd (formerly Shandong Yimeng Xinhua Pharmaceutical Factory) is located in Yiyuan County, Zibo City, Shandong Province, is the first powder injection manufacturer. Ruiyang Pharmaceutical Co., Ltd. adhering to the "Ruiyang Pharmaceutical, benefit the four sides" business purposes, adhere to the innovation-based, quality first, internal strong management, external brand, cohesion of elites, open *** win business strategy, "loyalty and trustworthiness, perseverance, hard-working, innovative and enterprising! ", from a third-line enterprise to prepare for war and desertion, it has grown into one of the top 50 enterprises of Chinese medicine and become one of the pillar enterprises of Yiyuan County. Up to now, the enterprise has 49 varieties declared consistency evaluation (including the new registration of classified generic drug declaration), there have been 22 varieties over the evaluation.
Chenxin Pharmaceutical Co., Ltd. is a national high-tech enterprises, post-doctoral research stations, Shandong Province, Shandong Province, enterprise technology center, Shandong Province, antibiotics engineering technology research center, access to the National Development and Reform Commission Industrialization Support Fund, China Patent Shandong Star Enterprise and other honors. The total production capacity of the leading product I.V. reaches more than 600 million bottles (bags)/year, ranking the first in the domestic production of a single plant. Adhering to the concept of "pushing forward and innovating, honesty and trustworthiness", C&C Pharmaceuticals takes the responsibility of safeguarding the lives of patients, and devotes itself to independent research and development, and production of medicines that can fill the gaps in the country and have independent intellectual property rights. Up to now, the enterprise has 30 varieties declared consistency evaluation (including the new registration classification of generic drug declaration), 10 varieties have been evaluated.
From the perspective of varieties, in January, entecavir tablets had five companies over the evaluation, ranking first, atosiban acetate injection had three companies over the evaluation, ranking second, rivaroxaban tablets and many other varieties have two companies over the evaluation. Details are shown in the chart below.
Figure 3 Top 10 enterprises of varieties passed in January 2022
Data source: Pharmaceutical Intelligence Data, Pharmaceutical Intelligence Consulting
Entecavir tablets, applicable to the treatment of chronic adult hepatitis B with active viral replication, persistent elevation of serum alanine aminotransferase (ALT), or histology of the liver showing active lesions (including the compensated and decompensated stage) liver disease); also indicated for the treatment of nucleoside primed pediatric patients 2 to <18 years of age with chronic HBV-infected compensated liver disease with evidence of active viral replication and persistently elevated serum ALT levels or histologic evidence of moderate to severe inflammation and/or fibrosis. See Dosage for its specific use. As of today. Entecavir tablets have been declared by 35 companies for consistency evaluation (including the declaration of newly registered classified generic drugs), and 24 companies have passed the evaluation.
Atosiban Acetate Injection is indicated to delay imminent preterm labor in pregnant women with: ① regular uterine contractions of at least 30 seconds each, ≥ 4 contractions every 30 minutes; ② cervical dilatation of 1 to 3 cm (0 to 3 cm in the nulliparous state) and uterine softness/thinning of ≥ 50% - Age ≥ 18 years -24 to 33 full weeks of gestation; ③ Normal fetal heart rate. Atosiban Acetate Injection up to now there are 7 enterprises have declared consistency evaluation (including the new registration of classified generics declaration), there have been 5 enterprises have been evaluated.
54 varieties declared, injection over 60%
2022 January CDE new consistency evaluation acceptance number 88, involving 54 varieties of 53 enterprises, of which the proportion of injection again more than 60%.
Figure 4 Details of declared dosage forms in January 2022
Data source: Pharmaceutical Intelligence Data, organized by Pharmaceutical Intelligence Consulting
As far as declared varieties are concerned, in January 2022, piperacillin sodium tazobactam sodium for injection was the first to be contracted with 8 acceptance numbers. Cefotaxime sodium for injection, there are 7 acceptance number was hosted, ranked second. In addition, piperacillin sodium for injection had 4 acceptance numbers being hosted and ranked third. For details, see the following chart
Figure 5 Top 10 Variety Declaration Acceptance Numbers in January 2022
Data source: Pharmaceutical Intelligence Data, organized by Pharmaceutical Intelligence Consulting
Piperacillin Sodium Tazobactam Sodium for Injection is indicated for use in cases caused by Staphylococcus spp., Coliforms spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Providenciales spp., and Pseudomonas spp. which are susceptible to this product. Sepsis, complicated cystitis, pyelonephritis. Up to now there have been nine companies to declare consistency evaluation, only Qilutian and Huishi Pharmaceuticals and North China Pharmaceutical over the evaluation.
Cefotaxime Sodium for Injection is indicated for pneumonia and other lower respiratory tract infections, urinary tract infections, meningitis, sepsis, abdominal infections, pelvic infections, skin and soft tissue infections, reproductive tract infections, bone and joint infections caused by sensitive bacteria. Cefotaxime can be used as an optional drug for pediatric meningitis. So far there have been 13 companies to declare consistency evaluation, only Suzhou Sinochem Pharmaceutical injection piperacillin sodium products industry and Guangdong Jincheng Jinsu Pharmaceutical over the evaluation.
Piperacillin sodium for injection is suitable for sepsis, upper urinary tract and complex urinary tract infections, respiratory tract infections, biliary tract infections, abdominal infections, pelvic infections, and skin and soft tissue infections caused by sensitive Enterobacteriaceae, Pseudomonas aeruginosa, and Bacillus species. Piperacillin combined with aminoglycosides can also be used for infections in immunodeficient patients with granulocytopenia. Up to now there have been three companies to declare consistency evaluation, have not been evaluated.
From the enterprise point of view, in January, Shandong Lubao has seven acceptance number declaration consistency evaluation accepted, ranked first. The second is Chengdu Bite, Hainan General Sanyang have 5 acceptance number declaration consistency evaluation accepted, details see the following chart.
Figure 6 Top 10 companies declaring acceptance number in January 2022
Data source: Pharmaceutical Intelligence Data, Pharmaceutical Intelligence Consulting
Shandong Lubao is committed to the development of eco-pharmaceuticals, and adheres to the innovation of science and technology, marketing and management, and has walked out of a self-characterized road of development, and gradually become a modern large-scale enterprise mainly engaged in drug manufacturing and pharmaceutical trade, and also engaged in scientific research and consulting, It has gradually become a modernized large-scale enterprise group mainly engaged in pharmaceutical manufacturing and pharmaceutical trade, as well as scientific research consulting, technology development and quality monitoring. The company has declared / deemed to declare 28 varieties, of which 13 varieties have been evaluated.
Chengdu Bite Pharmaceuticals Co., Ltd. is a high-tech enterprise specializing in pharmaceutical innovation and high-quality drug research and development, production and sales, and has constructed six production bases and set up two major marketing systems for preparations and APIs. It integrates R&D, production and sales, covering the whole ecological pharmaceutical industry chain from intermediates, APIs to preparations. The company has declared/deemed to declare 74 varieties, 38 varieties have been evaluated.
Hainan General Sanyang Pharmaceutical Co., Ltd. was founded in 2001, located in No. 8, Haili Road, Xiuying District, Haikou City, Hainan Province, is a high-tech enterprise integrating pharmaceutical research and development and production. The company's shareholder is China Pharmaceutical and Health Industry Company Limited, which is subordinate to China General Technology (Group) Holding Company Limited. The company's products cover the categories of antibiotics, lipid regulating drugs, drugs for improving brain function, drugs for digestive system, etc., of which the enzyme-resistant compound antibiotic preparations are in the leading position in the industry. The company has declared/deemed to have declared 14 varieties, of which 4 have been evaluated.
Schedule 1: Detailed table of consistency evaluation passed (including deemed passed) in January 2022
Data as of February 08, 2022
Schedule 2: Detailed table of consistency evaluation declared in January 2022
Data as of February 08, 2022
Data source: Pharmaceutical Intelligence Data Generic Drugs Consistency evaluation analysis system
Responsibility Editor: Liuli
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