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Public drug landscapesDrug landscape

Bisoprolol Fumarate Tablets

As of 13 November 2026, for Bisoprolol Fumarate Tablets, 6 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 17 holders.

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
2026/11/13 06:42
Matching scope
Same generic name; dosage forms and combinations kept separate

US Orange Book listing

The brand names come from the US FDA Orange Book and describe US listing records for this active ingredient. They do not indicate that products under these brand names are approved or sold in China, or that Chinese applicants are affiliated with US holders.

Orange Book source export date: 2026/11/06. Version: 2026-11-06.

Showing 1 of 1 distinct brand names.

A brand with different source forms or statuses can appear on multiple rows and in both groups. Distinct brand names are counted once globally, with a limit of five.

Verified official English dosage form: Tablets. Listings are grouped by the source dosage form and route; records without a clear correspondence are listed in the other group. Grouping does not establish product equivalence.

Same dosage form

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
ZEBETA TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC NDA 019982 · Product no. 001, 002 TABLET ORAL DISCONTINUED 1992/07/31

Other dosage forms of the same ingredient

No listings in this group among the displayed brand names.

Same-form/route listings come first, followed by other forms/routes. Within each group, source prescription/OTC listings precede discontinued listings; unknown statuses are last. Each status bucket is ordered by earliest approval date, ascending: pre-1982 records first, missing dates last; ties by brand name, application number and product number. The first five distinct brands in this order are selected globally. All retained source facts for those brands are shown in their own groups; a brand spanning both groups counts once.

Ingredient cross-list details ↗

Which companies are listed, and at what stages?

Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.

Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.

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
Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanizedJilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanized国药准字H202643412026/05/192.5mgGeneric approved under the new chemical-drug registration classificationCDE
Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanizedJilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanized国药准字H202643402026/05/195mgGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Giantech Hi-technology Development Co., Ltd.Sichuan Sai Zhuo Pharma Co., Ltd. romanized国药准字H202638452026/04/075mgGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Giantech Hi-technology Development Co., Ltd.Sichuan Sai Zhuo Pharma Co., Ltd. romanized国药准字H202638442026/04/072.5mgGeneric approved under the new chemical-drug registration classificationCDE
Shanghai Jian Hui Le Xiang Pharmaceuticals Technology Co., Ltd. romanizedShanghai Heng Shan Pharma Co., Ltd. romanized国药准字H202630062026/01/055mgGeneric approved under the new chemical-drug registration classificationCDE
Shanghai Jian Hui Le Xiang Pharmaceuticals Technology Co., Ltd. romanizedShanghai Heng Shan Pharma Co., Ltd. romanized国药准字H202630052026/01/052.5mgGeneric approved under the new chemical-drug registration classificationCDE
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanizedSichuan Yi Ke Pharmaceutical Co., Ltd. romanized国药准字H202558772025/11/042.5mgGeneric approved under the new chemical-drug registration classificationCDE
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanizedSichuan Yi Ke Pharmaceutical Co., Ltd. romanized国药准字H202558762025/11/045mgGeneric approved under the new chemical-drug registration classificationCDE
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITEDXin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized国药准字H202556402025/09/305mgGeneric approved under the new chemical-drug registration classificationCDE
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITEDXin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized国药准字H202556412025/09/302.5mgGeneric approved under the new chemical-drug registration classificationCDE
Shandong Xin Shi Dai Pharma Co., Ltd. romanizedShandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H202543412025/05/275mgGeneric approved under the new chemical-drug registration classificationCDE
Shandong Xin Shi Dai Pharma Co., Ltd. romanizedShandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H202543402025/05/272.5mgGeneric approved under the new chemical-drug registration classificationCDE
Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanizedBeijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanized国药准字H202539402025/04/155mgGeneric approved under the new chemical-drug registration classificationCDE
Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanizedBeijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanized国药准字H202539392025/04/152.5mgGeneric approved under the new chemical-drug registration classificationCDE
Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanizedHaerbin Zhen Bao Pharmaceutical Co., Ltd. romanized国药准字H202530122025/01/025mgGeneric approved under the new chemical-drug registration classificationCDE
Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanizedHaerbin Zhen Bao Pharmaceutical Co., Ltd. romanized国药准字H202530132025/01/022.5mgGeneric approved under the new chemical-drug registration classificationCDE
Shanxi De Yuan Tang Pharma Co., Ltd. romanizedShanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202447942024/09/035mgGeneric approved under the new chemical-drug registration classificationCDE
Shanxi De Yuan Tang Pharma Co., Ltd. romanizedShanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202447932024/09/032.5mgGeneric approved under the new chemical-drug registration classificationCDE
ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.国药准字H202439472024/06/045mgGeneric approved under the new chemical-drug registration classificationCDE
ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.国药准字H202439462024/06/042.5mgGeneric approved under the new chemical-drug registration classificationCDE
Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanizedNingbo Menovo Tiankang Pharmaceutical Co., Ltd.国药准字H202433482024/03/195mgGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Xiong Di Pharma Co., Ltd. romanizedHuayi Pharmaceuticals (Anhui) Co., Ltd.国药准字H202430092024/01/095mgGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Xiong Di Pharma Co., Ltd. romanizedHuayi Pharmaceuticals (Anhui) Co., Ltd.国药准字H202430102024/01/092.5mgGeneric approved under the new chemical-drug registration classificationCDE
Hexal AGLek S.A.国药准字HJ201702612023/04/285mgDrug that passed quality-and-efficacy consistency evaluationCDE
Hexal AGLek S. A.国药准字HJ201702592023/03/225mgDrug that passed quality-and-efficacy consistency evaluationCDE
Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanizedYue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized国药准字H201730372020/05/225mgDrug that passed quality-and-efficacy consistency evaluationCDE
Chengdu Easton Biopharmaceuticals Co.,Ltd.Chengdu Easton Biopharmaceuticals Co.,Ltd.国药准字H200830072020/01/072.5mgDrug that passed quality-and-efficacy consistency evaluationCDE
Beijing Hua Su Pharmaceutical Co., Ltd. romanizedBeijing Hua Su Pharmaceutical Co., Ltd. romanized国药准字H200231322019/06/212.5mgDrug that passed quality-and-efficacy consistency evaluationCDE
Beijing Hua Su Pharmaceutical Co., Ltd. romanizedBeijing Hua Su Pharmaceutical Co., Ltd. romanized国药准字H109700822019/06/215mgDrug that passed quality-and-efficacy consistency evaluationCDE
Name not romanizedChengdu Easton Biopharmaceuticals Co.,Ltd.国药准字H200830082018/07/205mgDrug that passed quality-and-efficacy consistency evaluationCDE
Merck Serono GmbHMerck KGaAH201604752005/09/152.5mgImported originator drugCDE
Merck Serono GmbHMerck KGaAH201604741995/06/085mgImported originator drugCDE

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
Beijing Hua Su Pharmaceutical Co., Ltd. romanized国药准字H200231322.5mgCategory AXC07ABB087A001010100052NHSA
Chengdu Easton Biopharmaceuticals Co.,Ltd.国药准字H200830072.5mgCategory AXC07ABB087A001010102181NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized国药准字H202558765mgCategory AXC07ABB087A001010102251NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202447932.5mgCategory AXC07ABB087A001010102877NHSA
Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized国药准字H202530125mgCategory AXC07ABB087A001010103783NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H202556405mgCategory AXC07ABB087A001010104187NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.国药准字H202439462.5mgCategory AXC07ABB087A001010104658NHSA
Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized国药准字H201730375mgCategory AXC07ABB087A001010104918NHSA
Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized国药准字H202539392.5mgCategory AXC07ABB087A001010104960NHSA
Hexal AG国药准字HJ201702595mgCategory AXC07ABB087A001010178495NHSA
Merck Serono GmbHH201604752.5mgCategory AXC07ABB087A001010179462NHSA
Chengdu Giantech Hi-technology Development Co., Ltd.国药准字H202638455mgCategory AXC07ABB087A001010183325NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430095mgCategory AXC07ABB087A001010183781NHSA
Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized国药准字H202433485mgCategory AXC07ABB087A001010184240NHSA
Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized国药准字H202643405mgCategory AXC07ABB087A001010185558NHSA
Beijing Hua Su Pharmaceutical Co., Ltd. romanized国药准字H200231322.5mgCategory AXC07ABB087A001010200052NHSA
Chengdu Easton Biopharmaceuticals Co.,Ltd.国药准字H200830072.5mgCategory AXC07ABB087A001010202181NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized国药准字H202558765mgCategory AXC07ABB087A001010202251NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202447932.5mgCategory AXC07ABB087A001010202877NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H202556405mgCategory AXC07ABB087A001010204187NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.国药准字H202439462.5mgCategory AXC07ABB087A001010204658NHSA
Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized国药准字H201730375mgCategory AXC07ABB087A001010204918NHSA
Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized国药准字H202539392.5mgCategory AXC07ABB087A001010204960NHSA
Salutas Pharma GmbH国药准字J201710435mgCategory AXC07ABB087A001010209659NHSA
Chengdu Giantech Hi-technology Development Co., Ltd.国药准字H202638455mgCategory AXC07ABB087A001010283325NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430095mgCategory AXC07ABB087A001010283781NHSA
Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized国药准字H202433485mgCategory AXC07ABB087A001010284240NHSA
Chengdu Easton Biopharmaceuticals Co.,Ltd.国药准字H200830072.5mgCategory AXC07ABB087A001010302181NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized国药准字H202558765mgCategory AXC07ABB087A001010302251NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202447932.5mgCategory AXC07ABB087A001010302877NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H202556405mgCategory AXC07ABB087A001010304187NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.国药准字H202439462.5mgCategory AXC07ABB087A001010304658NHSA
Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized国药准字H201730375mgCategory AXC07ABB087A001010304918NHSA
Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized国药准字H202539392.5mgCategory AXC07ABB087A001010304960NHSA
Lek.S.A.国药准字HJ201702615mgCategory AXC07ABB087A001010378495NHSA
Chengdu Giantech Hi-technology Development Co., Ltd.国药准字H202638455mgCategory AXC07ABB087A001010383325NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430095mgCategory AXC07ABB087A001010383781NHSA
Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized国药准字H202433485mgCategory AXC07ABB087A001010384240NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized国药准字H202558765mgCategory AXC07ABB087A001010402251NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202447932.5mgCategory AXC07ABB087A001010402877NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H202556405mgCategory AXC07ABB087A001010404187NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.国药准字H202439462.5mgCategory AXC07ABB087A001010404658NHSA
Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized国药准字H201730375mgCategory AXC07ABB087A001010404918NHSA
Hexal AG国药准字HJ201702595mgCategory AXC07ABB087A001010478495NHSA
Chengdu Giantech Hi-technology Development Co., Ltd.国药准字H202638455mgCategory AXC07ABB087A001010483325NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430095mgCategory AXC07ABB087A001010483781NHSA
Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized国药准字H202433485mgCategory AXC07ABB087A001010484240NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized国药准字H202558765mgCategory AXC07ABB087A001010502251NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202447932.5mgCategory AXC07ABB087A001010502877NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H202556405mgCategory AXC07ABB087A001010504187NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H202543402.5mgCategory AXC07ABB087A001010504188NHSA
Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized国药准字H201730375mgCategory AXC07ABB087A001010504918NHSA
Lek.S.A.国药准字HJ201702615mgCategory AXC07ABB087A001010578495NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430095mgCategory AXC07ABB087A001010583781NHSA
Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized国药准字H202433485mgCategory AXC07ABB087A001010584240NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202447932.5mgCategory AXC07ABB087A001010602877NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H202556405mgCategory AXC07ABB087A001010604187NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H202543402.5mgCategory AXC07ABB087A001010604188NHSA
Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized国药准字H201730375mgCategory AXC07ABB087A001010604918NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430095mgCategory AXC07ABB087A001010683781NHSA
Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized国药准字H202433485mgCategory AXC07ABB087A001010684240NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202447932.5mgCategory AXC07ABB087A001010702877NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H202543402.5mgCategory AXC07ABB087A001010704188NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430095mgCategory AXC07ABB087A001010783781NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202447932.5mgCategory AXC07ABB087A001010802877NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H202543402.5mgCategory AXC07ABB087A001010804188NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430095mgCategory AXC07ABB087A001010883781NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430095mgCategory AXC07ABB087A001010983781NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430095mgCategory AXC07ABB087A001011083781NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430095mgCategory AXC07ABB087A001011183781NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430095mgCategory AXC07ABB087A001011283781NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430095mgCategory AXC07ABB087A001011383781NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430095mgCategory AXC07ABB087A001011483781NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430095mgCategory AXC07ABB087A001011583781NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430095mgCategory AXC07ABB087A001011683781NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430095mgCategory AXC07ABB087A001011783781NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430095mgCategory AXC07ABB087A001011883781NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430095mgCategory AXC07ABB087A001011983781NHSA
Beijing Hua Su Pharmaceutical Co., Ltd. romanized国药准字H109700825mgCategory AXC07ABB087A001020100052NHSA
Chengdu Easton Biopharmaceuticals Co.,Ltd.国药准字H200830085mgCategory AXC07ABB087A001020102181NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized国药准字H202558772.5mgCategory AXC07ABB087A001020102251NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202447945mgCategory AXC07ABB087A001020102877NHSA
Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized国药准字H202530132.5mgCategory AXC07ABB087A001020103783NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H202556412.5mgCategory AXC07ABB087A001020104187NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.国药准字H202439475mgCategory AXC07ABB087A001020104658NHSA
Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized国药准字H202539405mgCategory AXC07ABB087A001020104960NHSA
Merck Healthcare Germany GmbH国药准字HJ201604745mgCategory AXC07ABB087A001020179462NHSA
Chengdu Giantech Hi-technology Development Co., Ltd.国药准字H202638442.5mgCategory AXC07ABB087A001020183325NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430102.5mgCategory AXC07ABB087A001020183781NHSA
Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized国药准字H202643405mgCategory AXC07ABB087A001020185558NHSA
Beijing Hua Su Pharmaceutical Co., Ltd. romanized国药准字H109700825mgCategory AXC07ABB087A001020200052NHSA
Chengdu Easton Biopharmaceuticals Co.,Ltd.国药准字H200830085mgCategory AXC07ABB087A001020202181NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized国药准字H202558772.5mgCategory AXC07ABB087A001020202251NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202447945mgCategory AXC07ABB087A001020202877NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H202556412.5mgCategory AXC07ABB087A001020204187NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.国药准字H202439475mgCategory AXC07ABB087A001020204658NHSA
Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized国药准字H202539405mgCategory AXC07ABB087A001020204960NHSA
Chengdu Giantech Hi-technology Development Co., Ltd.国药准字H202638442.5mgCategory AXC07ABB087A001020283325NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430102.5mgCategory AXC07ABB087A001020283781NHSA
Beijing Hua Su Pharmaceutical Co., Ltd. romanized国药准字H109700825mgCategory AXC07ABB087A001020300052NHSA
Chengdu Easton Biopharmaceuticals Co.,Ltd.国药准字H200830085mgCategory AXC07ABB087A001020302181NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized国药准字H202558772.5mgCategory AXC07ABB087A001020302251NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202447945mgCategory AXC07ABB087A001020302877NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H202556412.5mgCategory AXC07ABB087A001020304187NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.国药准字H202439475mgCategory AXC07ABB087A001020304658NHSA
Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized国药准字H202539405mgCategory AXC07ABB087A001020304960NHSA
Chengdu Giantech Hi-technology Development Co., Ltd.国药准字H202638442.5mgCategory AXC07ABB087A001020383325NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430102.5mgCategory AXC07ABB087A001020383781NHSA
Chengdu Easton Biopharmaceuticals Co.,Ltd.国药准字H200830085mgCategory AXC07ABB087A001020402181NHSA
Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized国药准字H202558772.5mgCategory AXC07ABB087A001020402251NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202447945mgCategory AXC07ABB087A001020402877NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H202556412.5mgCategory AXC07ABB087A001020404187NHSA
ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.国药准字H202439475mgCategory AXC07ABB087A001020404658NHSA
Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized国药准字H202539405mgCategory AXC07ABB087A001020404960NHSA
Chengdu Giantech Hi-technology Development Co., Ltd.国药准字H202638442.5mgCategory AXC07ABB087A001020483325NHSA
Zhejiang Xiong Di Pharma Co., Ltd. romanized国药准字H202430102.5mgCategory AXC07ABB087A001020483781NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202447945mgCategory AXC07ABB087A001020502877NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H202556412.5mgCategory AXC07ABB087A001020504187NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H202543415mgCategory AXC07ABB087A001020504188NHSA
Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized国药准字H202539405mgCategory AXC07ABB087A001020504960NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202447945mgCategory AXC07ABB087A001020602877NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H202556412.5mgCategory AXC07ABB087A001020604187NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H202543415mgCategory AXC07ABB087A001020604188NHSA
Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized国药准字H202539405mgCategory AXC07ABB087A001020604960NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202447945mgCategory AXC07ABB087A001020702877NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H202543415mgCategory AXC07ABB087A001020704188NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202447945mgCategory AXC07ABB087A001020802877NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H202543415mgCategory AXC07ABB087A001020804188NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202447945mgCategory AXC07ABB087A001020902877NHSA
Shanxi De Yuan Tang Pharma Co., Ltd. romanized国药准字H202447945mgCategory AXC07ABB087A001021002877NHSA
Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized国药准字H202643405mgCategory AXC07ABB087A001030185558NHSA
Mo Ke Pharmaceutical (Jiangsu) Co., Ltd. romanized国药准字H202050065mgCategory AXC07ABB087A001040181152NHSA
Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized国药准字H202643405mgCategory AXC07ABB087A001040185558NHSA
Mo Ke Pharmaceutical (Jiangsu) Co., Ltd. romanized国药准字H202050065mgCategory AXC07ABB087A001040381152NHSA
Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized国药准字H202643412.5mgCategory AXC07ABB087A001050185558NHSA
Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized国药准字H202643412.5mgCategory AXC07ABB087A001060185558NHSA
Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized国药准字H202643412.5mgCategory AXC07ABB087A001070185558NHSA
Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized国药准字H202643412.5mgCategory AXC07ABB087A001080185558NHSA
Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized国药准字H202643405mgCategory AXC07ABB087A001090185558NHSA
Nanchang Li Dong Pharmaceuticals Technology Co., Ltd. romanized国药准字H202643412.5mgCategory AXC07ABB087A001100185558NHSA

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
Shandong Xin Shi Dai Pharma Co., Ltd. romanizedCYHB2601921Supplement2026/10/21Not stated by sourceCDE
Shandong Xin Shi Dai Pharma Co., Ltd. romanizedCYHB2601920Supplement2026/10/21Not stated by sourceCDE
Jinan Gao Hua Pharmaceutical Co., Ltd. romanizedCYHS2601728Generic2026/07/20Not stated by sourceCDE
Jinan Gao Hua Pharmaceutical Co., Ltd. romanizedCYHS2601727Generic2026/07/20Not stated by sourceCDE
Yuan Da Pharmaceuticals (Hubei) Co., Ltd. romanized; Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanizedCYHS2600046Generic2026/01/06Not stated by sourceCDE
Yuan Da Pharmaceuticals (Hubei) Co., Ltd. romanized; Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanizedCYHS2600045Generic2026/01/06Not 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
Jinan Gao Hua Pharmaceutical Co., Ltd. romanizedCYHS2601728Generic2026/07/20Not stated by sourceCDE
Jinan Gao Hua Pharmaceutical Co., Ltd. romanizedCYHS2601727Generic2026/07/20Not stated by sourceCDE
Yuan Da Pharmaceuticals (Hubei) Co., Ltd. romanized; Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanizedCYHS2600046Generic2026/01/06Not stated by sourceCDE
Yuan Da Pharmaceuticals (Hubei) Co., Ltd. romanized; Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanizedCYHS2600045Generic2026/01/06Not 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 · No verified English nameMANGALAM DRUGS & ORGANICS LIMITEDY20230000663IExact ingredient2025/06/13CDE
富马酸比索洛尔 · No verified English nameUNICHEM LABORATORIES LIMITEDY20200000629AExact ingredient2023/02/08CDE
富马酸比索洛尔 · No verified English nameXin Dong Sheng Ji Co., Ltd. romanizedY20190021601AExact ingredient2024/05/17CDE
富马酸比索洛尔 · No verified English nameWan Te Pharmaceutical (Hainan) Co., Ltd. romanizedY20190006118AExact ingredient2025/07/10CDE
富马酸比索洛尔 · No verified English nameBeijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanizedY20190005788AExact ingredient2026/09/29CDE
富马酸比索洛尔 · No verified English nameJilin Hui Kang Pharmaceutical Co., Ltd. romanizedY20190005732AExact ingredient2025/12/17CDE
富马酸比索洛尔 · No verified English nameBeijing Hua Su Pharmaceutical Co., Ltd. romanizedY20190004497AExact ingredient2024/01/17CDE
富马酸比索洛尔 · No verified English nameSichuan Qing Mu Pharmaceutical Co., Ltd. romanizedY20190001402AExact ingredient2024/07/18CDE
富马酸比索洛尔 · No verified English nameMOEHS IBERICA S.L.Y20180000720IExact ingredient2018/08/01CDE
富马酸比索洛尔 · No verified English nameTaiwan Biotech Co.,Ltd.Y20170001503AExact ingredient2026/01/14CDE
富马酸比索洛尔 · No verified English nameIpca Laboratories LimitedY20170001028AExact ingredient2026/04/28CDE
富马酸比索洛尔 · No verified English nameMerck 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: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.

This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.

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

    Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized; Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanized

    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

    Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized; Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanized

    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

    Shandong Xin Shi Dai Pharma Co., Ltd. romanized

    CYHB2601921

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

    View source ↗
  4. 2026/10/21Accepted

    Shandong Xin Shi Dai Pharma Co., Ltd. romanized

    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: 2026/11/13 06:42
Chemical-drug catalogue
Last successful update: 2026/11/13 06:39

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: 2026/11/13 06:41
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: 2026/11/12 18:32 · Current coverage may be incomplete

First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.

Drug Clinical Trial Registry and Information Disclosure Platform
Last successful update: 2026/11/13 08:09 · 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: 7/30; discovered pending details: 13. 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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