Monthly
US$200
Billed every month
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 2 applicationsNo longer listed under review: 2 applications
Current coverage may be incomplete
Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.
Company names, approval identifiers and strengths are retained as recorded in the Chinese sources. Category labels include the original wording for verification.
Loaded records: 17 holders; 4 in the quality-and-efficacy consistency-evaluation category, and 12 in the new chemical-registration-classification generic category. Category counts may overlap.
| Marketing authorization holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| 南昌理洞医药科技有限公司 | 吉林天衡英睿制药有限公司 | 国药准字H20264341 | 2026/05/19 | 2.5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 南昌理洞医药科技有限公司 | 吉林天衡英睿制药有限公司 | 国药准字H20264340 | 2026/05/19 | 5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 成都欣捷高新技术开发股份有限公司 | 四川赛卓药业股份有限公司 | 国药准字H20263845 | 2026/04/07 | 5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 成都欣捷高新技术开发股份有限公司 | 四川赛卓药业股份有限公司 | 国药准字H20263844 | 2026/04/07 | 2.5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 上海坚辉乐祥医药科技有限公司 | 上海衡山药业有限公司 | 国药准字H20263006 | 2026/01/05 | 5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 上海坚辉乐祥医药科技有限公司 | 上海衡山药业有限公司 | 国药准字H20263005 | 2026/01/05 | 2.5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 四川依科制药有限公司 | 四川依科制药有限公司 | 国药准字H20255877 | 2025/11/04 | 2.5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 四川依科制药有限公司 | 四川依科制药有限公司 | 国药准字H20255876 | 2025/11/04 | 5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 山东新华制药股份有限公司 | 新华制药(高密)有限公司 | 国药准字H20255640 | 2025/09/30 | 5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 山东新华制药股份有限公司 | 新华制药(高密)有限公司 | 国药准字H20255641 | 2025/09/30 | 2.5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 山东新时代药业有限公司 | 山东新时代药业有限公司 | 国药准字H20254341 | 2025/05/27 | 5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 山东新时代药业有限公司 | 山东新时代药业有限公司 | 国药准字H20254340 | 2025/05/27 | 2.5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 湖南千金湘江药业股份有限公司 | 北京金城泰尔制药有限公司 | 国药准字H20253940 | 2025/04/15 | 5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 湖南千金湘江药业股份有限公司 | 北京金城泰尔制药有限公司 | 国药准字H20253939 | 2025/04/15 | 2.5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 哈尔滨珍宝制药有限公司 | 哈尔滨珍宝制药有限公司 | 国药准字H20253012 | 2025/01/02 | 5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 哈尔滨珍宝制药有限公司 | 哈尔滨珍宝制药有限公司 | 国药准字H20253013 | 2025/01/02 | 2.5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 山西德元堂药业有限公司 | 山西德元堂药业有限公司 | 国药准字H20244794 | 2024/09/03 | 5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 山西德元堂药业有限公司 | 山西德元堂药业有限公司 | 国药准字H20244793 | 2024/09/03 | 2.5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 浙江京新药业股份有限公司 | 浙江京新药业股份有限公司 | 国药准字H20243947 | 2024/06/04 | 5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 浙江京新药业股份有限公司 | 浙江京新药业股份有限公司 | 国药准字H20243946 | 2024/06/04 | 2.5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 宁波科尔康美诺华药业有限公司 | 宁波美诺华天康药业有限公司 | 国药准字H20243348 | 2024/03/19 | 5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 浙江兄弟药业有限公司 | 华益药业科技(安徽)有限公司 | 国药准字H20243009 | 2024/01/09 | 5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 浙江兄弟药业有限公司 | 华益药业科技(安徽)有限公司 | 国药准字H20243010 | 2024/01/09 | 2.5mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| Hexal AG | Lek S.A. | 国药准字HJ20170261 | 2023/04/28 | 5mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| Hexal AG | Lek S. A. | 国药准字HJ20170259 | 2023/03/22 | 5mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 岳阳新华达制药有限公司 | 岳阳新华达制药有限公司 | 国药准字H20173037 | 2020/05/22 | 5mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 成都苑东生物制药股份有限公司 | 成都苑东生物制药股份有限公司 | 国药准字H20083007 | 2020/01/07 | 2.5mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 北京华素制药股份有限公司 | 北京华素制药股份有限公司 | 国药准字H20023132 | 2019/06/21 | 2.5mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 北京华素制药股份有限公司 | 北京华素制药股份有限公司 | 国药准字H10970082 | 2019/06/21 | 5mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| — | 成都苑东生物制药股份有限公司 | 国药准字H20083008 | 2018/07/20 | 5mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| Merck Serono GmbH | Merck KGaA | H20160475 | 2005/09/15 | 2.5mg | Imported originator drug (进口原研药品) | CDE |
| Merck Serono GmbH | Merck KGaA | H20160474 | 1995/06/08 | 5mg | Imported originator drug (进口原研药品) | CDE |
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
Loaded records: 32 distinct approval numbers and 20 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 北京华素制药股份有限公司 | 国药准字H20023132 | 2.5mg | Category A (甲) | XC07ABB087A001010100052 | NHSA |
| 成都苑东生物制药股份有限公司 | 国药准字H20083007 | 2.5mg | Category A (甲) | XC07ABB087A001010102181 | NHSA |
| 四川依科制药有限公司 | 国药准字H20255876 | 5mg | Category A (甲) | XC07ABB087A001010102251 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20244793 | 2.5mg | Category A (甲) | XC07ABB087A001010102877 | NHSA |
| 哈尔滨珍宝制药有限公司 | 国药准字H20253012 | 5mg | Category A (甲) | XC07ABB087A001010103783 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20255640 | 5mg | Category A (甲) | XC07ABB087A001010104187 | NHSA |
| 浙江京新药业股份有限公司 | 国药准字H20243946 | 2.5mg | Category A (甲) | XC07ABB087A001010104658 | NHSA |
| 岳阳新华达制药有限公司 | 国药准字H20173037 | 5mg | Category A (甲) | XC07ABB087A001010104918 | NHSA |
| 湖南千金湘江药业股份有限公司 | 国药准字H20253939 | 2.5mg | Category A (甲) | XC07ABB087A001010104960 | NHSA |
| Hexal AG | 国药准字HJ20170259 | 5mg | Category A (甲) | XC07ABB087A001010178495 | NHSA |
| Merck Serono GmbH | H20160475 | 2.5mg | Category A (甲) | XC07ABB087A001010179462 | NHSA |
| 成都欣捷高新技术开发股份有限公司 | 国药准字H20263845 | 5mg | Category A (甲) | XC07ABB087A001010183325 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243009 | 5mg | Category A (甲) | XC07ABB087A001010183781 | NHSA |
| 宁波科尔康美诺华药业有限公司 | 国药准字H20243348 | 5mg | Category A (甲) | XC07ABB087A001010184240 | NHSA |
| 南昌理洞医药科技有限公司 | 国药准字H20264340 | 5mg | Category A (甲) | XC07ABB087A001010185558 | NHSA |
| 北京华素制药股份有限公司 | 国药准字H20023132 | 2.5mg | Category A (甲) | XC07ABB087A001010200052 | NHSA |
| 成都苑东生物制药股份有限公司 | 国药准字H20083007 | 2.5mg | Category A (甲) | XC07ABB087A001010202181 | NHSA |
| 四川依科制药有限公司 | 国药准字H20255876 | 5mg | Category A (甲) | XC07ABB087A001010202251 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20244793 | 2.5mg | Category A (甲) | XC07ABB087A001010202877 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20255640 | 5mg | Category A (甲) | XC07ABB087A001010204187 | NHSA |
| 浙江京新药业股份有限公司 | 国药准字H20243946 | 2.5mg | Category A (甲) | XC07ABB087A001010204658 | NHSA |
| 岳阳新华达制药有限公司 | 国药准字H20173037 | 5mg | Category A (甲) | XC07ABB087A001010204918 | NHSA |
| 湖南千金湘江药业股份有限公司 | 国药准字H20253939 | 2.5mg | Category A (甲) | XC07ABB087A001010204960 | NHSA |
| Salutas Pharma GmbH | 国药准字J20171043 | 5mg | Category A (甲) | XC07ABB087A001010209659 | NHSA |
| 成都欣捷高新技术开发股份有限公司 | 国药准字H20263845 | 5mg | Category A (甲) | XC07ABB087A001010283325 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243009 | 5mg | Category A (甲) | XC07ABB087A001010283781 | NHSA |
| 宁波科尔康美诺华药业有限公司 | 国药准字H20243348 | 5mg | Category A (甲) | XC07ABB087A001010284240 | NHSA |
| 成都苑东生物制药股份有限公司 | 国药准字H20083007 | 2.5mg | Category A (甲) | XC07ABB087A001010302181 | NHSA |
| 四川依科制药有限公司 | 国药准字H20255876 | 5mg | Category A (甲) | XC07ABB087A001010302251 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20244793 | 2.5mg | Category A (甲) | XC07ABB087A001010302877 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20255640 | 5mg | Category A (甲) | XC07ABB087A001010304187 | NHSA |
| 浙江京新药业股份有限公司 | 国药准字H20243946 | 2.5mg | Category A (甲) | XC07ABB087A001010304658 | NHSA |
| 岳阳新华达制药有限公司 | 国药准字H20173037 | 5mg | Category A (甲) | XC07ABB087A001010304918 | NHSA |
| 湖南千金湘江药业股份有限公司 | 国药准字H20253939 | 2.5mg | Category A (甲) | XC07ABB087A001010304960 | NHSA |
| Lek.S.A. | 国药准字HJ20170261 | 5mg | Category A (甲) | XC07ABB087A001010378495 | NHSA |
| 成都欣捷高新技术开发股份有限公司 | 国药准字H20263845 | 5mg | Category A (甲) | XC07ABB087A001010383325 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243009 | 5mg | Category A (甲) | XC07ABB087A001010383781 | NHSA |
| 宁波科尔康美诺华药业有限公司 | 国药准字H20243348 | 5mg | Category A (甲) | XC07ABB087A001010384240 | NHSA |
| 四川依科制药有限公司 | 国药准字H20255876 | 5mg | Category A (甲) | XC07ABB087A001010402251 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20244793 | 2.5mg | Category A (甲) | XC07ABB087A001010402877 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20255640 | 5mg | Category A (甲) | XC07ABB087A001010404187 | NHSA |
| 浙江京新药业股份有限公司 | 国药准字H20243946 | 2.5mg | Category A (甲) | XC07ABB087A001010404658 | NHSA |
| 岳阳新华达制药有限公司 | 国药准字H20173037 | 5mg | Category A (甲) | XC07ABB087A001010404918 | NHSA |
| Hexal AG | 国药准字HJ20170259 | 5mg | Category A (甲) | XC07ABB087A001010478495 | NHSA |
| 成都欣捷高新技术开发股份有限公司 | 国药准字H20263845 | 5mg | Category A (甲) | XC07ABB087A001010483325 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243009 | 5mg | Category A (甲) | XC07ABB087A001010483781 | NHSA |
| 宁波科尔康美诺华药业有限公司 | 国药准字H20243348 | 5mg | Category A (甲) | XC07ABB087A001010484240 | NHSA |
| 四川依科制药有限公司 | 国药准字H20255876 | 5mg | Category A (甲) | XC07ABB087A001010502251 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20244793 | 2.5mg | Category A (甲) | XC07ABB087A001010502877 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20255640 | 5mg | Category A (甲) | XC07ABB087A001010504187 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20254340 | 2.5mg | Category A (甲) | XC07ABB087A001010504188 | NHSA |
| 岳阳新华达制药有限公司 | 国药准字H20173037 | 5mg | Category A (甲) | XC07ABB087A001010504918 | NHSA |
| Lek.S.A. | 国药准字HJ20170261 | 5mg | Category A (甲) | XC07ABB087A001010578495 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243009 | 5mg | Category A (甲) | XC07ABB087A001010583781 | NHSA |
| 宁波科尔康美诺华药业有限公司 | 国药准字H20243348 | 5mg | Category A (甲) | XC07ABB087A001010584240 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20244793 | 2.5mg | Category A (甲) | XC07ABB087A001010602877 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20255640 | 5mg | Category A (甲) | XC07ABB087A001010604187 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20254340 | 2.5mg | Category A (甲) | XC07ABB087A001010604188 | NHSA |
| 岳阳新华达制药有限公司 | 国药准字H20173037 | 5mg | Category A (甲) | XC07ABB087A001010604918 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243009 | 5mg | Category A (甲) | XC07ABB087A001010683781 | NHSA |
| 宁波科尔康美诺华药业有限公司 | 国药准字H20243348 | 5mg | Category A (甲) | XC07ABB087A001010684240 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20244793 | 2.5mg | Category A (甲) | XC07ABB087A001010702877 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20254340 | 2.5mg | Category A (甲) | XC07ABB087A001010704188 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243009 | 5mg | Category A (甲) | XC07ABB087A001010783781 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20244793 | 2.5mg | Category A (甲) | XC07ABB087A001010802877 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20254340 | 2.5mg | Category A (甲) | XC07ABB087A001010804188 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243009 | 5mg | Category A (甲) | XC07ABB087A001010883781 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243009 | 5mg | Category A (甲) | XC07ABB087A001010983781 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243009 | 5mg | Category A (甲) | XC07ABB087A001011083781 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243009 | 5mg | Category A (甲) | XC07ABB087A001011183781 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243009 | 5mg | Category A (甲) | XC07ABB087A001011283781 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243009 | 5mg | Category A (甲) | XC07ABB087A001011383781 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243009 | 5mg | Category A (甲) | XC07ABB087A001011483781 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243009 | 5mg | Category A (甲) | XC07ABB087A001011583781 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243009 | 5mg | Category A (甲) | XC07ABB087A001011683781 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243009 | 5mg | Category A (甲) | XC07ABB087A001011783781 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243009 | 5mg | Category A (甲) | XC07ABB087A001011883781 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243009 | 5mg | Category A (甲) | XC07ABB087A001011983781 | NHSA |
| 北京华素制药股份有限公司 | 国药准字H10970082 | 5mg | Category A (甲) | XC07ABB087A001020100052 | NHSA |
| 成都苑东生物制药股份有限公司 | 国药准字H20083008 | 5mg | Category A (甲) | XC07ABB087A001020102181 | NHSA |
| 四川依科制药有限公司 | 国药准字H20255877 | 2.5mg | Category A (甲) | XC07ABB087A001020102251 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20244794 | 5mg | Category A (甲) | XC07ABB087A001020102877 | NHSA |
| 哈尔滨珍宝制药有限公司 | 国药准字H20253013 | 2.5mg | Category A (甲) | XC07ABB087A001020103783 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20255641 | 2.5mg | Category A (甲) | XC07ABB087A001020104187 | NHSA |
| 浙江京新药业股份有限公司 | 国药准字H20243947 | 5mg | Category A (甲) | XC07ABB087A001020104658 | NHSA |
| 湖南千金湘江药业股份有限公司 | 国药准字H20253940 | 5mg | Category A (甲) | XC07ABB087A001020104960 | NHSA |
| Merck Healthcare Germany GmbH | 国药准字HJ20160474 | 5mg | Category A (甲) | XC07ABB087A001020179462 | NHSA |
| 成都欣捷高新技术开发股份有限公司 | 国药准字H20263844 | 2.5mg | Category A (甲) | XC07ABB087A001020183325 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243010 | 2.5mg | Category A (甲) | XC07ABB087A001020183781 | NHSA |
| 南昌理洞医药科技有限公司 | 国药准字H20264340 | 5mg | Category A (甲) | XC07ABB087A001020185558 | NHSA |
| 北京华素制药股份有限公司 | 国药准字H10970082 | 5mg | Category A (甲) | XC07ABB087A001020200052 | NHSA |
| 成都苑东生物制药股份有限公司 | 国药准字H20083008 | 5mg | Category A (甲) | XC07ABB087A001020202181 | NHSA |
| 四川依科制药有限公司 | 国药准字H20255877 | 2.5mg | Category A (甲) | XC07ABB087A001020202251 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20244794 | 5mg | Category A (甲) | XC07ABB087A001020202877 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20255641 | 2.5mg | Category A (甲) | XC07ABB087A001020204187 | NHSA |
| 浙江京新药业股份有限公司 | 国药准字H20243947 | 5mg | Category A (甲) | XC07ABB087A001020204658 | NHSA |
| 湖南千金湘江药业股份有限公司 | 国药准字H20253940 | 5mg | Category A (甲) | XC07ABB087A001020204960 | NHSA |
| 成都欣捷高新技术开发股份有限公司 | 国药准字H20263844 | 2.5mg | Category A (甲) | XC07ABB087A001020283325 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243010 | 2.5mg | Category A (甲) | XC07ABB087A001020283781 | NHSA |
| 北京华素制药股份有限公司 | 国药准字H10970082 | 5mg | Category A (甲) | XC07ABB087A001020300052 | NHSA |
| 成都苑东生物制药股份有限公司 | 国药准字H20083008 | 5mg | Category A (甲) | XC07ABB087A001020302181 | NHSA |
| 四川依科制药有限公司 | 国药准字H20255877 | 2.5mg | Category A (甲) | XC07ABB087A001020302251 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20244794 | 5mg | Category A (甲) | XC07ABB087A001020302877 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20255641 | 2.5mg | Category A (甲) | XC07ABB087A001020304187 | NHSA |
| 浙江京新药业股份有限公司 | 国药准字H20243947 | 5mg | Category A (甲) | XC07ABB087A001020304658 | NHSA |
| 湖南千金湘江药业股份有限公司 | 国药准字H20253940 | 5mg | Category A (甲) | XC07ABB087A001020304960 | NHSA |
| 成都欣捷高新技术开发股份有限公司 | 国药准字H20263844 | 2.5mg | Category A (甲) | XC07ABB087A001020383325 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243010 | 2.5mg | Category A (甲) | XC07ABB087A001020383781 | NHSA |
| 成都苑东生物制药股份有限公司 | 国药准字H20083008 | 5mg | Category A (甲) | XC07ABB087A001020402181 | NHSA |
| 四川依科制药有限公司 | 国药准字H20255877 | 2.5mg | Category A (甲) | XC07ABB087A001020402251 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20244794 | 5mg | Category A (甲) | XC07ABB087A001020402877 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20255641 | 2.5mg | Category A (甲) | XC07ABB087A001020404187 | NHSA |
| 浙江京新药业股份有限公司 | 国药准字H20243947 | 5mg | Category A (甲) | XC07ABB087A001020404658 | NHSA |
| 湖南千金湘江药业股份有限公司 | 国药准字H20253940 | 5mg | Category A (甲) | XC07ABB087A001020404960 | NHSA |
| 成都欣捷高新技术开发股份有限公司 | 国药准字H20263844 | 2.5mg | Category A (甲) | XC07ABB087A001020483325 | NHSA |
| 浙江兄弟药业有限公司 | 国药准字H20243010 | 2.5mg | Category A (甲) | XC07ABB087A001020483781 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20244794 | 5mg | Category A (甲) | XC07ABB087A001020502877 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20255641 | 2.5mg | Category A (甲) | XC07ABB087A001020504187 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20254341 | 5mg | Category A (甲) | XC07ABB087A001020504188 | NHSA |
| 湖南千金湘江药业股份有限公司 | 国药准字H20253940 | 5mg | Category A (甲) | XC07ABB087A001020504960 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20244794 | 5mg | Category A (甲) | XC07ABB087A001020602877 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20255641 | 2.5mg | Category A (甲) | XC07ABB087A001020604187 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20254341 | 5mg | Category A (甲) | XC07ABB087A001020604188 | NHSA |
| 湖南千金湘江药业股份有限公司 | 国药准字H20253940 | 5mg | Category A (甲) | XC07ABB087A001020604960 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20244794 | 5mg | Category A (甲) | XC07ABB087A001020702877 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20254341 | 5mg | Category A (甲) | XC07ABB087A001020704188 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20244794 | 5mg | Category A (甲) | XC07ABB087A001020802877 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20254341 | 5mg | Category A (甲) | XC07ABB087A001020804188 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20244794 | 5mg | Category A (甲) | XC07ABB087A001020902877 | NHSA |
| 山西德元堂药业有限公司 | 国药准字H20244794 | 5mg | Category A (甲) | XC07ABB087A001021002877 | NHSA |
| 南昌理洞医药科技有限公司 | 国药准字H20264340 | 5mg | Category A (甲) | XC07ABB087A001030185558 | NHSA |
| 默克制药(江苏)有限公司 | 国药准字H20205006 | 5mg | Category A (甲) | XC07ABB087A001040181152 | NHSA |
| 南昌理洞医药科技有限公司 | 国药准字H20264340 | 5mg | Category A (甲) | XC07ABB087A001040185558 | NHSA |
| 默克制药(江苏)有限公司 | 国药准字H20205006 | 5mg | Category A (甲) | XC07ABB087A001040381152 | NHSA |
| 南昌理洞医药科技有限公司 | 国药准字H20264341 | 2.5mg | Category A (甲) | XC07ABB087A001050185558 | NHSA |
| 南昌理洞医药科技有限公司 | 国药准字H20264341 | 2.5mg | Category A (甲) | XC07ABB087A001060185558 | NHSA |
| 南昌理洞医药科技有限公司 | 国药准字H20264341 | 2.5mg | Category A (甲) | XC07ABB087A001070185558 | NHSA |
| 南昌理洞医药科技有限公司 | 国药准字H20264341 | 2.5mg | Category A (甲) | XC07ABB087A001080185558 | NHSA |
| 南昌理洞医药科技有限公司 | 国药准字H20264340 | 5mg | Category A (甲) | XC07ABB087A001090185558 | NHSA |
| 南昌理洞医药科技有限公司 | 国药准字H20264341 | 2.5mg | Category A (甲) | XC07ABB087A001100185558 | NHSA |
Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.
Loaded records: 6 filings and 3 distinct first applicants.
Supplement 2 · Generic 4
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 山东新时代药业有限公司 | CYHB2601921 | Supplement | 2026/10/21 | Not stated by source | CDE |
| 山东新时代药业有限公司 | CYHB2601920 | Supplement | 2026/10/21 | Not stated by source | CDE |
| 济南高华制药有限公司 | CYHS2601728 | Generic | 2026/07/20 | Not stated by source | CDE |
| 济南高华制药有限公司 | CYHS2601727 | Generic | 2026/07/20 | Not stated by source | CDE |
| 远大医药(湖北)有限公司;远大医药(中国)有限公司 | CYHS2600046 | Generic | 2026/01/06 | Not stated by source | CDE |
| 远大医药(湖北)有限公司;远大医药(中国)有限公司 | CYHS2600045 | Generic | 2026/01/06 | Not stated by source | CDE |
Loaded records: 4 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 济南高华制药有限公司 | CYHS2601728 | Generic | 2026/07/20 | Not stated by source | CDE |
| 济南高华制药有限公司 | CYHS2601727 | Generic | 2026/07/20 | Not stated by source | CDE |
| 远大医药(湖北)有限公司;远大医药(中国)有限公司 | CYHS2600046 | Generic | 2026/01/06 | Not stated by source | CDE |
| 远大医药(湖北)有限公司;远大医药(中国)有限公司 | CYHS2600045 | Generic | 2026/01/06 | Not stated by source | CDE |
Non-component matches: 10 companies with A status and 2 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 富马酸比索洛尔 | MANGALAM DRUGS & ORGANICS LIMITED | Y20230000663 | I | Exact ingredient | 2025/06/13 | CDE |
| 富马酸比索洛尔 | UNICHEM LABORATORIES LIMITED | Y20200000629 | A | Exact ingredient | 2023/02/08 | CDE |
| 富马酸比索洛尔 | 信东生技股份有限公司 | Y20190021601 | A | Exact ingredient | 2024/05/17 | CDE |
| 富马酸比索洛尔 | 万特制药(海南)有限公司 | Y20190006118 | A | Exact ingredient | 2025/07/10 | CDE |
| 富马酸比索洛尔 | 北京金城泰尔制药有限公司 | Y20190005788 | A | Exact ingredient | 2026/09/29 | CDE |
| 富马酸比索洛尔 | 吉林汇康制药有限公司 | Y20190005732 | A | Exact ingredient | 2025/12/17 | CDE |
| 富马酸比索洛尔 | 北京华素制药股份有限公司 | Y20190004497 | A | Exact ingredient | 2024/01/17 | CDE |
| 富马酸比索洛尔 | 四川青木制药有限公司 | Y20190001402 | A | Exact ingredient | 2024/07/18 | CDE |
| 富马酸比索洛尔 | MOEHS IBERICA S.L. | Y20180000720 | I | Exact ingredient | 2018/08/01 | CDE |
| 富马酸比索洛尔 | Taiwan Biotech Co.,Ltd. | Y20170001503 | A | Exact ingredient | 2026/01/14 | CDE |
| 富马酸比索洛尔 | Ipca Laboratories Limited | Y20170001028 | A | Exact ingredient | 2026/04/28 | CDE |
| 富马酸比索洛尔 | Merck KGaA | Y20170000769 | A | Exact ingredient | 2025/10/19 | CDE |
A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.
Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately.
Trial registration does not mean an application will follow.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
CYHS2504503
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2025/12/31
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHS2504502
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2025/12/31
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.
First index-page publication dates: 2026-10-26 to 2026-11-10; 0 pages pending. Covers loaded notices only, not a complete historical approval database.
Daily collection reads new registrations. Backfill covers registration numbers from 2025 onward (CTR2025/CTR2026), not first-publication years. States are dated observations; revisions are not tracked.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
Public-product searches scanned: 3/30; discovered pending details: 20. Record counts in unscanned portions remain unknown.
Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.
Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.
Free follow
Up to 3 drugs per email address, in one weekly digest. Starts after email confirmation; unsubscribe at any time.
Subscriptions
US$200
Billed every month
US$540
Billed every three months
US$180 per month
US$1,920
Billed every year
US$160 per month
Online subscriptions are not enabled. The form below registers interest; it does not charge or activate access.
Separate one-time purchase
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
Subscriptions and comparison-table access are purchased separately. Neither includes the other.
US$490
One payment · 12 months of access
Online comparison-table purchase is not enabled.
Billed by Creem, our merchant of record · Terms · Refund policy