药格局YaoGeJu

Public drug landscapesDrug landscape

Bisoprolol Fumarate Tablets(富马酸比索洛尔片)

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

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Complete CDE snapshot
2026/11/10 07:27
Matching scope
Same generic name; dosage forms and combinations kept separate

Which companies are listed, and at what stages?

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.

Chemical-drug catalogue

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 holderManufacturerApproval numberApprovedStrength / specificationCatalogue 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 AGLek 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 AGLek 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 GmbHMerck KGaA H20160475 2005/09/15 2.5mg Imported originator drug (进口原研药品) CDE
Merck Serono GmbHMerck 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.

NHSA drug codes

Loaded records: 32 distinct approval numbers and 20 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
北京华素制药股份有限公司 国药准字H20023132 2.5mg Category A (甲) XC07ABB087A001010100052NHSA
成都苑东生物制药股份有限公司 国药准字H20083007 2.5mg Category A (甲) XC07ABB087A001010102181NHSA
四川依科制药有限公司 国药准字H20255876 5mg Category A (甲) XC07ABB087A001010102251NHSA
山西德元堂药业有限公司 国药准字H20244793 2.5mg Category A (甲) XC07ABB087A001010102877NHSA
哈尔滨珍宝制药有限公司 国药准字H20253012 5mg Category A (甲) XC07ABB087A001010103783NHSA
山东新华制药股份有限公司 国药准字H20255640 5mg Category A (甲) XC07ABB087A001010104187NHSA
浙江京新药业股份有限公司 国药准字H20243946 2.5mg Category A (甲) XC07ABB087A001010104658NHSA
岳阳新华达制药有限公司 国药准字H20173037 5mg Category A (甲) XC07ABB087A001010104918NHSA
湖南千金湘江药业股份有限公司 国药准字H20253939 2.5mg Category A (甲) XC07ABB087A001010104960NHSA
Hexal AG 国药准字HJ20170259 5mg Category A (甲) XC07ABB087A001010178495NHSA
Merck Serono GmbH H20160475 2.5mg Category A (甲) XC07ABB087A001010179462NHSA
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) XC07ABB087A001010183325NHSA
浙江兄弟药业有限公司 国药准字H20243009 5mg Category A (甲) XC07ABB087A001010183781NHSA
宁波科尔康美诺华药业有限公司 国药准字H20243348 5mg Category A (甲) XC07ABB087A001010184240NHSA
南昌理洞医药科技有限公司 国药准字H20264340 5mg Category A (甲) XC07ABB087A001010185558NHSA
北京华素制药股份有限公司 国药准字H20023132 2.5mg Category A (甲) XC07ABB087A001010200052NHSA
成都苑东生物制药股份有限公司 国药准字H20083007 2.5mg Category A (甲) XC07ABB087A001010202181NHSA
四川依科制药有限公司 国药准字H20255876 5mg Category A (甲) XC07ABB087A001010202251NHSA
山西德元堂药业有限公司 国药准字H20244793 2.5mg Category A (甲) XC07ABB087A001010202877NHSA
山东新华制药股份有限公司 国药准字H20255640 5mg Category A (甲) XC07ABB087A001010204187NHSA
浙江京新药业股份有限公司 国药准字H20243946 2.5mg Category A (甲) XC07ABB087A001010204658NHSA
岳阳新华达制药有限公司 国药准字H20173037 5mg Category A (甲) XC07ABB087A001010204918NHSA
湖南千金湘江药业股份有限公司 国药准字H20253939 2.5mg Category A (甲) XC07ABB087A001010204960NHSA
Salutas Pharma GmbH 国药准字J20171043 5mg Category A (甲) XC07ABB087A001010209659NHSA
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) XC07ABB087A001010283325NHSA
浙江兄弟药业有限公司 国药准字H20243009 5mg Category A (甲) XC07ABB087A001010283781NHSA
宁波科尔康美诺华药业有限公司 国药准字H20243348 5mg Category A (甲) XC07ABB087A001010284240NHSA
成都苑东生物制药股份有限公司 国药准字H20083007 2.5mg Category A (甲) XC07ABB087A001010302181NHSA
四川依科制药有限公司 国药准字H20255876 5mg Category A (甲) XC07ABB087A001010302251NHSA
山西德元堂药业有限公司 国药准字H20244793 2.5mg Category A (甲) XC07ABB087A001010302877NHSA
山东新华制药股份有限公司 国药准字H20255640 5mg Category A (甲) XC07ABB087A001010304187NHSA
浙江京新药业股份有限公司 国药准字H20243946 2.5mg Category A (甲) XC07ABB087A001010304658NHSA
岳阳新华达制药有限公司 国药准字H20173037 5mg Category A (甲) XC07ABB087A001010304918NHSA
湖南千金湘江药业股份有限公司 国药准字H20253939 2.5mg Category A (甲) XC07ABB087A001010304960NHSA
Lek.S.A. 国药准字HJ20170261 5mg Category A (甲) XC07ABB087A001010378495NHSA
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) XC07ABB087A001010383325NHSA
浙江兄弟药业有限公司 国药准字H20243009 5mg Category A (甲) XC07ABB087A001010383781NHSA
宁波科尔康美诺华药业有限公司 国药准字H20243348 5mg Category A (甲) XC07ABB087A001010384240NHSA
四川依科制药有限公司 国药准字H20255876 5mg Category A (甲) XC07ABB087A001010402251NHSA
山西德元堂药业有限公司 国药准字H20244793 2.5mg Category A (甲) XC07ABB087A001010402877NHSA
山东新华制药股份有限公司 国药准字H20255640 5mg Category A (甲) XC07ABB087A001010404187NHSA
浙江京新药业股份有限公司 国药准字H20243946 2.5mg Category A (甲) XC07ABB087A001010404658NHSA
岳阳新华达制药有限公司 国药准字H20173037 5mg Category A (甲) XC07ABB087A001010404918NHSA
Hexal AG 国药准字HJ20170259 5mg Category A (甲) XC07ABB087A001010478495NHSA
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) XC07ABB087A001010483325NHSA
浙江兄弟药业有限公司 国药准字H20243009 5mg Category A (甲) XC07ABB087A001010483781NHSA
宁波科尔康美诺华药业有限公司 国药准字H20243348 5mg Category A (甲) XC07ABB087A001010484240NHSA
四川依科制药有限公司 国药准字H20255876 5mg Category A (甲) XC07ABB087A001010502251NHSA
山西德元堂药业有限公司 国药准字H20244793 2.5mg Category A (甲) XC07ABB087A001010502877NHSA
山东新华制药股份有限公司 国药准字H20255640 5mg Category A (甲) XC07ABB087A001010504187NHSA
山东新时代药业有限公司 国药准字H20254340 2.5mg Category A (甲) XC07ABB087A001010504188NHSA
岳阳新华达制药有限公司 国药准字H20173037 5mg Category A (甲) XC07ABB087A001010504918NHSA
Lek.S.A. 国药准字HJ20170261 5mg Category A (甲) XC07ABB087A001010578495NHSA
浙江兄弟药业有限公司 国药准字H20243009 5mg Category A (甲) XC07ABB087A001010583781NHSA
宁波科尔康美诺华药业有限公司 国药准字H20243348 5mg Category A (甲) XC07ABB087A001010584240NHSA
山西德元堂药业有限公司 国药准字H20244793 2.5mg Category A (甲) XC07ABB087A001010602877NHSA
山东新华制药股份有限公司 国药准字H20255640 5mg Category A (甲) XC07ABB087A001010604187NHSA
山东新时代药业有限公司 国药准字H20254340 2.5mg Category A (甲) XC07ABB087A001010604188NHSA
岳阳新华达制药有限公司 国药准字H20173037 5mg Category A (甲) XC07ABB087A001010604918NHSA
浙江兄弟药业有限公司 国药准字H20243009 5mg Category A (甲) XC07ABB087A001010683781NHSA
宁波科尔康美诺华药业有限公司 国药准字H20243348 5mg Category A (甲) XC07ABB087A001010684240NHSA
山西德元堂药业有限公司 国药准字H20244793 2.5mg Category A (甲) XC07ABB087A001010702877NHSA
山东新时代药业有限公司 国药准字H20254340 2.5mg Category A (甲) XC07ABB087A001010704188NHSA
浙江兄弟药业有限公司 国药准字H20243009 5mg Category A (甲) XC07ABB087A001010783781NHSA
山西德元堂药业有限公司 国药准字H20244793 2.5mg Category A (甲) XC07ABB087A001010802877NHSA
山东新时代药业有限公司 国药准字H20254340 2.5mg Category A (甲) XC07ABB087A001010804188NHSA
浙江兄弟药业有限公司 国药准字H20243009 5mg Category A (甲) XC07ABB087A001010883781NHSA
浙江兄弟药业有限公司 国药准字H20243009 5mg Category A (甲) XC07ABB087A001010983781NHSA
浙江兄弟药业有限公司 国药准字H20243009 5mg Category A (甲) XC07ABB087A001011083781NHSA
浙江兄弟药业有限公司 国药准字H20243009 5mg Category A (甲) XC07ABB087A001011183781NHSA
浙江兄弟药业有限公司 国药准字H20243009 5mg Category A (甲) XC07ABB087A001011283781NHSA
浙江兄弟药业有限公司 国药准字H20243009 5mg Category A (甲) XC07ABB087A001011383781NHSA
浙江兄弟药业有限公司 国药准字H20243009 5mg Category A (甲) XC07ABB087A001011483781NHSA
浙江兄弟药业有限公司 国药准字H20243009 5mg Category A (甲) XC07ABB087A001011583781NHSA
浙江兄弟药业有限公司 国药准字H20243009 5mg Category A (甲) XC07ABB087A001011683781NHSA
浙江兄弟药业有限公司 国药准字H20243009 5mg Category A (甲) XC07ABB087A001011783781NHSA
浙江兄弟药业有限公司 国药准字H20243009 5mg Category A (甲) XC07ABB087A001011883781NHSA
浙江兄弟药业有限公司 国药准字H20243009 5mg Category A (甲) XC07ABB087A001011983781NHSA
北京华素制药股份有限公司 国药准字H10970082 5mg Category A (甲) XC07ABB087A001020100052NHSA
成都苑东生物制药股份有限公司 国药准字H20083008 5mg Category A (甲) XC07ABB087A001020102181NHSA
四川依科制药有限公司 国药准字H20255877 2.5mg Category A (甲) XC07ABB087A001020102251NHSA
山西德元堂药业有限公司 国药准字H20244794 5mg Category A (甲) XC07ABB087A001020102877NHSA
哈尔滨珍宝制药有限公司 国药准字H20253013 2.5mg Category A (甲) XC07ABB087A001020103783NHSA
山东新华制药股份有限公司 国药准字H20255641 2.5mg Category A (甲) XC07ABB087A001020104187NHSA
浙江京新药业股份有限公司 国药准字H20243947 5mg Category A (甲) XC07ABB087A001020104658NHSA
湖南千金湘江药业股份有限公司 国药准字H20253940 5mg Category A (甲) XC07ABB087A001020104960NHSA
Merck Healthcare Germany GmbH 国药准字HJ20160474 5mg Category A (甲) XC07ABB087A001020179462NHSA
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) XC07ABB087A001020183325NHSA
浙江兄弟药业有限公司 国药准字H20243010 2.5mg Category A (甲) XC07ABB087A001020183781NHSA
南昌理洞医药科技有限公司 国药准字H20264340 5mg Category A (甲) XC07ABB087A001020185558NHSA
北京华素制药股份有限公司 国药准字H10970082 5mg Category A (甲) XC07ABB087A001020200052NHSA
成都苑东生物制药股份有限公司 国药准字H20083008 5mg Category A (甲) XC07ABB087A001020202181NHSA
四川依科制药有限公司 国药准字H20255877 2.5mg Category A (甲) XC07ABB087A001020202251NHSA
山西德元堂药业有限公司 国药准字H20244794 5mg Category A (甲) XC07ABB087A001020202877NHSA
山东新华制药股份有限公司 国药准字H20255641 2.5mg Category A (甲) XC07ABB087A001020204187NHSA
浙江京新药业股份有限公司 国药准字H20243947 5mg Category A (甲) XC07ABB087A001020204658NHSA
湖南千金湘江药业股份有限公司 国药准字H20253940 5mg Category A (甲) XC07ABB087A001020204960NHSA
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) XC07ABB087A001020283325NHSA
浙江兄弟药业有限公司 国药准字H20243010 2.5mg Category A (甲) XC07ABB087A001020283781NHSA
北京华素制药股份有限公司 国药准字H10970082 5mg Category A (甲) XC07ABB087A001020300052NHSA
成都苑东生物制药股份有限公司 国药准字H20083008 5mg Category A (甲) XC07ABB087A001020302181NHSA
四川依科制药有限公司 国药准字H20255877 2.5mg Category A (甲) XC07ABB087A001020302251NHSA
山西德元堂药业有限公司 国药准字H20244794 5mg Category A (甲) XC07ABB087A001020302877NHSA
山东新华制药股份有限公司 国药准字H20255641 2.5mg Category A (甲) XC07ABB087A001020304187NHSA
浙江京新药业股份有限公司 国药准字H20243947 5mg Category A (甲) XC07ABB087A001020304658NHSA
湖南千金湘江药业股份有限公司 国药准字H20253940 5mg Category A (甲) XC07ABB087A001020304960NHSA
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) XC07ABB087A001020383325NHSA
浙江兄弟药业有限公司 国药准字H20243010 2.5mg Category A (甲) XC07ABB087A001020383781NHSA
成都苑东生物制药股份有限公司 国药准字H20083008 5mg Category A (甲) XC07ABB087A001020402181NHSA
四川依科制药有限公司 国药准字H20255877 2.5mg Category A (甲) XC07ABB087A001020402251NHSA
山西德元堂药业有限公司 国药准字H20244794 5mg Category A (甲) XC07ABB087A001020402877NHSA
山东新华制药股份有限公司 国药准字H20255641 2.5mg Category A (甲) XC07ABB087A001020404187NHSA
浙江京新药业股份有限公司 国药准字H20243947 5mg Category A (甲) XC07ABB087A001020404658NHSA
湖南千金湘江药业股份有限公司 国药准字H20253940 5mg Category A (甲) XC07ABB087A001020404960NHSA
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) XC07ABB087A001020483325NHSA
浙江兄弟药业有限公司 国药准字H20243010 2.5mg Category A (甲) XC07ABB087A001020483781NHSA
山西德元堂药业有限公司 国药准字H20244794 5mg Category A (甲) XC07ABB087A001020502877NHSA
山东新华制药股份有限公司 国药准字H20255641 2.5mg Category A (甲) XC07ABB087A001020504187NHSA
山东新时代药业有限公司 国药准字H20254341 5mg Category A (甲) XC07ABB087A001020504188NHSA
湖南千金湘江药业股份有限公司 国药准字H20253940 5mg Category A (甲) XC07ABB087A001020504960NHSA
山西德元堂药业有限公司 国药准字H20244794 5mg Category A (甲) XC07ABB087A001020602877NHSA
山东新华制药股份有限公司 国药准字H20255641 2.5mg Category A (甲) XC07ABB087A001020604187NHSA
山东新时代药业有限公司 国药准字H20254341 5mg Category A (甲) XC07ABB087A001020604188NHSA
湖南千金湘江药业股份有限公司 国药准字H20253940 5mg Category A (甲) XC07ABB087A001020604960NHSA
山西德元堂药业有限公司 国药准字H20244794 5mg Category A (甲) XC07ABB087A001020702877NHSA
山东新时代药业有限公司 国药准字H20254341 5mg Category A (甲) XC07ABB087A001020704188NHSA
山西德元堂药业有限公司 国药准字H20244794 5mg Category A (甲) XC07ABB087A001020802877NHSA
山东新时代药业有限公司 国药准字H20254341 5mg Category A (甲) XC07ABB087A001020804188NHSA
山西德元堂药业有限公司 国药准字H20244794 5mg Category A (甲) XC07ABB087A001020902877NHSA
山西德元堂药业有限公司 国药准字H20244794 5mg Category A (甲) XC07ABB087A001021002877NHSA
南昌理洞医药科技有限公司 国药准字H20264340 5mg Category A (甲) XC07ABB087A001030185558NHSA
默克制药(江苏)有限公司 国药准字H20205006 5mg Category A (甲) XC07ABB087A001040181152NHSA
南昌理洞医药科技有限公司 国药准字H20264340 5mg Category A (甲) XC07ABB087A001040185558NHSA
默克制药(江苏)有限公司 国药准字H20205006 5mg Category A (甲) XC07ABB087A001040381152NHSA
南昌理洞医药科技有限公司 国药准字H20264341 2.5mg Category A (甲) XC07ABB087A001050185558NHSA
南昌理洞医药科技有限公司 国药准字H20264341 2.5mg Category A (甲) XC07ABB087A001060185558NHSA
南昌理洞医药科技有限公司 国药准字H20264341 2.5mg Category A (甲) XC07ABB087A001070185558NHSA
南昌理洞医药科技有限公司 国药准字H20264341 2.5mg Category A (甲) XC07ABB087A001080185558NHSA
南昌理洞医药科技有限公司 国药准字H20264340 5mg Category A (甲) XC07ABB087A001090185558NHSA
南昌理洞医药科技有限公司 国药准字H20264341 2.5mg Category A (甲) XC07ABB087A001100185558NHSA

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.

Current under-review applications

Loaded records: 6 filings and 3 distinct first applicants.

Supplement 2 · Generic 4

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
山东新时代药业有限公司 CYHB2601921 Supplement2026/10/21Not stated by sourceCDE
山东新时代药业有限公司 CYHB2601920 Supplement2026/10/21Not stated by sourceCDE
济南高华制药有限公司 CYHS2601728 Generic2026/07/20Not stated by sourceCDE
济南高华制药有限公司 CYHS2601727 Generic2026/07/20Not stated by sourceCDE
远大医药(湖北)有限公司;远大医药(中国)有限公司 CYHS2600046 Generic2026/01/06Not stated by sourceCDE
远大医药(湖北)有限公司;远大医药(中国)有限公司 CYHS2600045 Generic2026/01/06Not stated by sourceCDE
New generic filings in 2026

Loaded records: 4 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
济南高华制药有限公司 CYHS2601728 Generic2026/07/20Not stated by sourceCDE
济南高华制药有限公司 CYHS2601727 Generic2026/07/20Not stated by sourceCDE
远大医药(湖北)有限公司;远大医药(中国)有限公司 CYHS2600046 Generic2026/01/06Not stated by sourceCDE
远大医药(湖北)有限公司;远大医药(中国)有限公司 CYHS2600045 Generic2026/01/06Not stated by sourceCDE
API registrations

Non-component matches: 10 companies with A status and 2 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
富马酸比索洛尔MANGALAM DRUGS & ORGANICS LIMITEDY20230000663IExact ingredient2025/06/13CDE
富马酸比索洛尔UNICHEM LABORATORIES LIMITEDY20200000629AExact ingredient2023/02/08CDE
富马酸比索洛尔信东生技股份有限公司Y20190021601AExact ingredient2024/05/17CDE
富马酸比索洛尔万特制药(海南)有限公司Y20190006118AExact ingredient2025/07/10CDE
富马酸比索洛尔北京金城泰尔制药有限公司Y20190005788AExact ingredient2026/09/29CDE
富马酸比索洛尔吉林汇康制药有限公司Y20190005732AExact ingredient2025/12/17CDE
富马酸比索洛尔北京华素制药股份有限公司Y20190004497AExact ingredient2024/01/17CDE
富马酸比索洛尔四川青木制药有限公司Y20190001402AExact ingredient2024/07/18CDE
富马酸比索洛尔MOEHS IBERICA S.L.Y20180000720IExact ingredient2018/08/01CDE
富马酸比索洛尔Taiwan Biotech Co.,Ltd.Y20170001503AExact ingredient2026/01/14CDE
富马酸比索洛尔Ipca Laboratories LimitedY20170001028AExact ingredient2026/04/28CDE
富马酸比索洛尔Merck KGaAY20170000769AExact ingredient2025/10/19CDE

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.

What changed recently?

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.

  1. 2026/10/23No longer listed under review

    上海金城素智药业有限公司;北京金城泰尔制药有限公司

    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 ↗
  2. 2026/10/23No longer listed under review

    上海金城素智药业有限公司;北京金城泰尔制药有限公司

    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 ↗
  3. 2026/10/21Accepted

    山东新时代药业有限公司

    CYHB2601921

    Fact date: 2026/10/21 · Site observation date: 2026/10/22

    View source ↗
  4. 2026/10/21Accepted

    山东新时代药业有限公司

    CYHB2601920

    Fact date: 2026/10/21 · Site observation date: 2026/10/22

    View source ↗

How current is each source?

CDE acceptances and review
Last successful update: 2026/11/10 07:27
Chemical-drug catalogue
Last successful update: 2026/11/10 07:23

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.

Full API register
Last successful update: 2026/11/10 07:25
NHSA drug codes
Last successful update: 2026/11/05 06:45

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.

NMPA drug delivery notices
Last successful update: 2026/11/10 18:31

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.

Drug Clinical Trial Registry and Information Disclosure Platform
Last successful update: 2026/11/10 08:10 · Current coverage may be incomplete

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.

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