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Public drug landscapesDrug landscape

Bumetanide Injection

As of 13 November 2026, for Bumetanide Injection, 13 applications are listed as under review at China's CDE; 3 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 39 holders.

Companies, stages and changes, with each record available on this page.

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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 2 of 2 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: Injection. 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
BUMEX VALIDUS PHARMACEUTICALS LLC NDA 018226 · Product no. 001 INJECTABLE INJECTION DISCONTINUED 1983/02/28

Other dosage forms of the same ingredient

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
BUMEX VALIDUS PHARMACEUTICALS LLC NDA 018225 · Product no. 001, 002 TABLET ORAL HUMAN PRESCRIPTION DRUG 1983/02/28
BUMEX VALIDUS PHARMACEUTICALS LLC NDA 018225 · Product no. 003 TABLET ORAL HUMAN PRESCRIPTION DRUG 1985/06/14
ENBUMYST CORSTASIS THERAPEUTICS INC NDA 219500 · Product no. 001 SPRAY NASAL HUMAN PRESCRIPTION DRUG 2025/09/12

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: 39 holders; 3 in the quality-and-efficacy consistency-evaluation category, and 35 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanizedXin He Yuan Sheng Pharmaceutical Co., Ltd. romanized国药准字H202662802026/10/134ml:1mgGeneric approved under the new chemical-drug registration classificationCDE
Zhongshan Wanhan Pharmaceuticals Co., Ltd.Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H202659322026/09/154ml:2mgGeneric approved under the new chemical-drug registration classificationCDE
Zhongshan Wanhan Pharmaceuticals Co., Ltd.Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H202659312026/09/152ml:1mgGeneric approved under the new chemical-drug registration classificationCDE
Shandong Nuo Ming Kang Drug Research Institute Co., Ltd. romanizedJi Ning Shen Zhou Pharmaceuticals Co., Ltd. romanized国药准字H202655962026/08/044ml:2mgGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Kai Yuan Pharma Co., Ltd. romanizedJiangsu Su Zhong Pharma Group Biopharmaceutical Co., Ltd. romanized国药准字H202655972026/08/044ml:2mgGeneric approved under the new chemical-drug registration classificationCDE
Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanizedJiu Quan Da De Li Pharmaceutical Co., Ltd. romanized国药准字H202654582026/08/044ml:1mgGeneric approved under the new chemical-drug registration classificationCDE
Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanizedJiu Quan Da De Li Pharmaceutical Co., Ltd. romanized国药准字H202654572026/08/042ml:0.5mgGeneric approved under the new chemical-drug registration classificationCDE
Yunnan Hua Pai Pharmaceuticals Technology Co., Ltd. romanizedChu Xiong He Chuang Pharma Co., Ltd. romanized国药准字H202655142026/08/044ml:2mgGeneric approved under the new chemical-drug registration classificationCDE
Henan Xin Tai Pharma Co., Ltd. romanizedHenan Xin Tai Pharma Co., Ltd. romanized国药准字H200573762026/07/302ml:0.5mgDrug that passed quality-and-efficacy consistency evaluationCDE
Shandong Fang Ming Pharma Group Co., Ltd. romanizedShandong Fang Ming Pharma Group Co., Ltd. romanized国药准字H202652132026/07/214ml:2mgGeneric approved under the new chemical-drug registration classificationCDE
Ningbo Da Hong Ying Pharma Co., Ltd. romanizedNingbo Da Hong Ying Pharma Co., Ltd. romanized国药准字H330209802026/06/262ml:0.5mgDrug that passed quality-and-efficacy consistency evaluationCDE
Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanizedJiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized国药准字H202647342026/06/104ml:2mgGeneric approved under the new chemical-drug registration classificationCDE
Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanizedChengdu Shi Hai Tong Pharma Co., Ltd. romanized国药准字H202691292026/06/021ml∶0.5mgGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Run Heng Pharmaceutical Co., Ltd. romanizedJiangsu Run Heng Pharmaceutical Co., Ltd. romanized国药准字H202645152026/05/272ml:1mgGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Run Heng Pharmaceutical Co., Ltd. romanizedJiangsu Run Heng Pharmaceutical Co., Ltd. romanized国药准字H202645142026/05/272ml:0.5mgGeneric approved under the new chemical-drug registration classificationCDE
Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanizedShandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized国药准字H202644792026/05/191ml : 0.5mgGeneric approved under the new chemical-drug registration classificationCDE
Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanizedShandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized国药准字H202644782026/05/194ml:2mgGeneric approved under the new chemical-drug registration classificationCDE
Shijiazhuang No.4 Pharmaceutical Co., Ltd.Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202644402026/05/191ml:0.5mgGeneric approved under the new chemical-drug registration classificationCDE
Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanizedSichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized国药准字H202690952026/04/211ml:0.5mgGeneric approved under the new chemical-drug registration classificationCDE
CISEN PHARMACEUTICAL CO., LTD.CISEN PHARMACEUTICAL CO., LTD.国药准字H202639512026/04/144ml:1mgGeneric approved under the new chemical-drug registration classificationCDE
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITEDShanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized国药准字H202638852026/04/074ml:1mgGeneric approved under the new chemical-drug registration classificationCDE
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITEDShanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized国药准字H202638842026/04/072ml:0.5mgGeneric approved under the new chemical-drug registration classificationCDE
Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanizedXin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized国药准字H202690772026/03/271ml:0.5mgGeneric approved under the new chemical-drug registration classificationCDE
Shijiazhuang No.4 Pharmaceutical Co., Ltd.Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202637232026/03/252ml:1mgGeneric approved under the new chemical-drug registration classificationCDE
Sichuan Wo Xiang Biopharmaceuticals Co., Ltd. romanizedChengdu Di Yi Pharmaceutical Co., Ltd. romanized国药准字H202634692026/02/254ml:2mgGeneric approved under the new chemical-drug registration classificationCDE
Suzhou Lang Ke Bio Technology Co., Ltd. romanizedYang Zhou Zhong Bao Pharma Co., Ltd. romanized国药准字H202631822026/01/202ml:1mgGeneric approved under the new chemical-drug registration classificationCDE
Suzhou Te Rui Pharma Co., Ltd. romanizedJiangsu Hua Yang Pharmaceutical Co., Ltd. romanized国药准字H202630652026/01/144ml : 2mgGeneric approved under the new chemical-drug registration classificationCDE
Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanizedSichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized国药准字H202630612026/01/144ml:1mgGeneric approved under the new chemical-drug registration classificationCDE
Suzhou Te Rui Pharma Co., Ltd. romanizedJiangsu Hua Yang Pharmaceutical Co., Ltd. romanized国药准字H202630662026/01/141ml : 0.5mgGeneric approved under the new chemical-drug registration classificationCDE
Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedHainan Zhuo Ke Pharmaceutical Co., Ltd. romanized国药准字H202630112026/01/051ml:0.5mgGeneric approved under the new chemical-drug registration classificationCDE
Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedHainan Zhuo Ke Pharmaceutical Co., Ltd. romanized国药准字H202630122026/01/054ml:2mgGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanizedShandong Hao Rui En Pharmaceutical Co., Ltd. romanized国药准字H202563012025/12/164ml:2mgGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanizedShandong Hao Rui En Pharmaceutical Co., Ltd. romanized国药准字H202563002025/12/162ml:1mgGeneric approved under the new chemical-drug registration classificationCDE
Beijing Liu Huan Pharma Co., Ltd. romanizedHua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized国药准字H202563112025/12/164ml∶2mgGeneric approved under the new chemical-drug registration classificationCDE
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanizedGuo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H202562352025/12/094ml:2mgGeneric approved under the new chemical-drug registration classificationCDE
Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanizedJiangsu Yue Xing Pharma Co., Ltd. romanized国药准字H202560322025/11/254ml:2mgGeneric approved under the new chemical-drug registration classificationCDE
Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanizedHua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized国药准字H202560332025/11/254ml∶2mgGeneric approved under the new chemical-drug registration classificationCDE
Qilu Pharmaceutical (Hainan) Co., LtdQilu Pharmaceutical (Hainan) Co., Ltd国药准字H202552752025/09/024ml: 2mgGeneric approved under the new chemical-drug registration classificationCDE
Shenzhen Ge Lai En Biopharmaceuticals Technology Co., Ltd. romanizedZhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H202553332025/09/024ml:1mgGeneric approved under the new chemical-drug registration classificationCDE
Zhongshan Wanhan Pharmaceuticals Co., Ltd.Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H202550302025/07/294ml:1mgGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanizedTai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized国药准字H202549212025/07/222ml:1mgGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanizedTai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized国药准字H202549202025/07/224ml:2mgGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanizedChengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized国药准字H202544562025/06/032ml∶0.5mgGeneric approved under the new chemical-drug registration classificationCDE
Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanizedChengdu Shi Hai Tong Pharma Co., Ltd. romanized国药准字H202540362025/04/304ml:2mgGeneric approved under the new chemical-drug registration classificationCDE
Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanizedSichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized国药准字H202536992025/03/254ml:2mgGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Easton Biopharmaceuticals Co.,Ltd.Chengdu Easton Biopharmaceuticals Co.,Ltd.国药准字H202532332025/01/244ml:1mgGeneric approved under the new chemical-drug registration classificationCDE
Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanizedXin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized国药准字H202497472024/12/174ml:2mgGeneric approved under the new chemical-drug registration classificationCDE
Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanizedChengdu Shi Hai Tong Pharma Co., Ltd. romanized国药准字H202497282024/12/104ml:2mgGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Giantech Hi-technology Development Co., Ltd.E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized国药准字H202445492024/07/304ml:1mgNot stated by sourceCDE
Gui Lin Nan Yao Co., Ltd. romanizedGui Lin Nan Yao Co., Ltd. romanized国药准字H200572252024/04/152ml:1mgDrug that passed quality-and-efficacy consistency evaluationCDE
Gui Lin Nan Yao Co., Ltd. romanizedGui Lin Nan Yao Co., Ltd. romanized国药准字H202470662024/04/151ml:0.5mgDrug that passed quality-and-efficacy consistency evaluationCDE
Ping Guang Pharmaceutical Co., Ltd. romanizedPing Guang Pharmaceutical Co., Ltd. romanized国药准字H202641242026/04/214ml:2mgGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanizedJiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized国药准字H202647352026/06/102ml:1mgGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Kang Tai Yuan Pharmaceuticals Technology Co., Ltd. romanizedHunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H202662912026/10/204ml:2mgGeneric approved under the new chemical-drug registration classificationCDE
Guangdong Jian Xin Pharmaceutical Co., Ltd. romanizedZhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H202645692026/05/274ml:1mgGeneric approved under the new chemical-drug registration classificationCDE

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: 57 distinct approval numbers and 45 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Beijing Shi Yong Kang Pharma Co., Ltd. romanized国药准字H110205872ml:0.5mgCategory BXC03CAB176B002010100137NHSA
Guangdong Bang Min Pharmaceutical Factory Co., Ltd. romanized国药准字H200668462ml:0.5mgCategory BXC03CAB176B002010100267NHSA
Shanghai He Feng Pharmaceutical Co., Ltd. romanized国药准字H310215232ml:0.5mgCategory BXC03CAB176B002010100673NHSA
Xi Nan Pharma Co., Ltd. romanized国药准字H500214612ml:0.5mgCategory BXC03CAB176B002010100978NHSA
Liaoning Yu Huang Pharma Co., Ltd. romanized国药准字H200835002ml:1mgCategory BXC03CAB176B002010101247NHSA
Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized国药准字H202647344ml:2mgCategory BXC03CAB176B002010101495NHSA
Hubei Jin Yao Pharma Co., Ltd. romanized国药准字H200570232ml:0.5mgCategory BXC03CAB176B002010101866NHSA
Wuhan Jiu An Pharma Co., Ltd. romanized国药准字H420208942ml:0.5mgCategory BXC03CAB176B002010101949NHSA
Sichuan Wo Xiang Biopharmaceuticals Co., Ltd. romanized国药准字H202634694ml:2mgCategory BXC03CAB176B002010102065NHSA
Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized国药准字H202536994ml:2mgCategory BXC03CAB176B002010102087NHSA
Chengdu Easton Biopharmaceuticals Co.,Ltd.国药准字H202532334ml:1mgCategory BXC03CAB176B002010102181NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202637232ml:1mgCategory BXC03CAB176B002010102763NHSA
Henan Xin Tai Pharma Co., Ltd. romanized国药准字H200573762ml:0.5mgCategory BXC03CAB176B002010103091NHSA
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H202562354ml:2mgCategory BXC03CAB176B002010103205NHSA
Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized国药准字H202497474ml: 2mgCategory BXC03CAB176B002010103216NHSA
Shandong Fang Ming Pharma Group Co., Ltd. romanized国药准字H202652134ml:2mgCategory BXC03CAB176B002010104083NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H202639514ml:1mgCategory BXC03CAB176B002010104127NHSA
Ningbo Da Hong Ying Pharma Co., Ltd. romanized国药准字H330209802ml:0.5mgCategory BXC03CAB176B002010104757NHSA
Fuzhou Hai Wang Fu Yao Pharmaceutical Co., Ltd. romanized国药准字H350204602ml:0.5mgCategory BXC03CAB176B002010104827NHSA
Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized国药准字H450200762ml:0.5mgCategory BXC03CAB176B002010105156NHSA
Gui Lin Nan Yao Co., Ltd. romanized国药准字H450209602ml:0.5mgCategory BXC03CAB176B002010105206NHSA
Hainan Jiu Chang Pharmaceutical Co., Ltd. romanized国药准字H200572482ml:0.5mgCategory BXC03CAB176B002010105843NHSA
Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H202552754ml: 2mgCategory BXC03CAB176B002010105847NHSA
Gansu Cheng Ji Bio Pharma Co., Ltd. romanized国药准字H201630982ml:0.5mgCategory BXC03CAB176B002010107698NHSA
Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized国药准字H202560334ml∶2mgCategory BXC03CAB176B002010109910NHSA
Zhongshan Wanhan Pharmaceuticals Co., Ltd.国药准字H202550304ml:1mgCategory BXC03CAB176B002010109920NHSA
Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized国药准字H202645694ml:1mgCategory BXC03CAB176B002010109921NHSA
Suzhou Te Rui Pharma Co., Ltd. romanized国药准字H202630654ml : 2mgCategory BXC03CAB176B002010110121NHSA
Ping Guang Pharmaceutical Co., Ltd. romanized国药准字H202641244ml:2mgCategory BXC03CAB176B002010180610NHSA
Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized国药准字H202630111ml:0.5mgCategory BXC03CAB176B002010182234NHSA
Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized国药准字H202640714ml : 2mgCategory BXC03CAB176B002010183094NHSA
Chengdu Giantech Hi-technology Development Co., Ltd.国药准字H202445494ml∶1mgCategory BXC03CAB176B002010183325NHSA
Suzhou Lang Ke Bio Technology Co., Ltd. romanized国药准字H202631822ml:1mgCategory BXC03CAB176B002010183485NHSA
Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized国药准字H202540364ml:2mgCategory BXC03CAB176B002010183960NHSA
Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized国药准字H202497284ml:2mgCategory BXC03CAB176B002010184135NHSA
Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized国药准字H202630614ml : 1mgCategory BXC03CAB176B002010184156NHSA
Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized国药准字H202549212ml:1mgCategory BXC03CAB176B002010184534NHSA
Chengdu Li Er Pharma Co., Ltd. romanized国药准字H202560364ml:2mgCategory BXC03CAB176B002010184779NHSA
Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized国药准字H202644784ml:2mgCategory BXC03CAB176B002010184954NHSA
Shenzhen Ge Lai En Biopharmaceuticals Technology Co., Ltd. romanized国药准字H202553334ml:1mgCategory BXC03CAB176B002010185074NHSA
Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized国药准字H202645152ml:1mgCategory BXC03CAB176B002010185467NHSA
Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized国药准字H202563002ml:1mgCategory BXC03CAB176B002010185482NHSA
Beijing Liu Huan Pharma Co., Ltd. romanized国药准字H202563114ml:2mgCategory BXC03CAB176B002010185484NHSA
Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized国药准字H202645142ml:0.5mgCategory BXC03CAB176B002010185560NHSA
Xi Nan Pharma Co., Ltd. romanized国药准字H500214612ml:0.5mgCategory BXC03CAB176B002010200978NHSA
Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized国药准字H202647344ml:2mgCategory BXC03CAB176B002010201495NHSA
Hubei Jin Yao Pharma Co., Ltd. romanized国药准字H200570232ml:0.5mgCategory BXC03CAB176B002010201866NHSA
Wuhan Jiu An Pharma Co., Ltd. romanized国药准字H420208942ml:0.5mgCategory BXC03CAB176B002010201949NHSA
Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized国药准字H202536994ml:2mgCategory BXC03CAB176B002010202087NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202637232ml:1mgCategory BXC03CAB176B002010202763NHSA
Henan Xin Tai Pharma Co., Ltd. romanized国药准字H200573762ml:0.5mgCategory BXC03CAB176B002010203091NHSA
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized国药准字H202562354ml:2mgCategory BXC03CAB176B002010203205NHSA
Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized国药准字H202497474ml: 2mgCategory BXC03CAB176B002010203216NHSA
Shandong Fang Ming Pharma Group Co., Ltd. romanized国药准字H202652134ml:2mgCategory BXC03CAB176B002010204083NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H202639514ml:1mgCategory BXC03CAB176B002010204127NHSA
Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized国药准字H450200762ml:0.5mgCategory BXC03CAB176B002010205156NHSA
Gui Lin Nan Yao Co., Ltd. romanized国药准字H450209602ml:0.5mgCategory BXC03CAB176B002010205206NHSA
Hainan Jiu Chang Pharmaceutical Co., Ltd. romanized国药准字H200572482ml:0.5mgCategory BXC03CAB176B002010205843NHSA
Gansu Cheng Ji Bio Pharma Co., Ltd. romanized国药准字H201630982ml:0.5mgCategory BXC03CAB176B002010207698NHSA
Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized国药准字H202645694ml:1mgCategory BXC03CAB176B002010209921NHSA
Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized国药准字H202630111ml:0.5mgCategory BXC03CAB176B002010282234NHSA
Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized国药准字H202640714ml : 2mgCategory BXC03CAB176B002010283094NHSA
Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized国药准字H202540364ml:2mgCategory BXC03CAB176B002010283960NHSA
Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized国药准字H202497284ml:2mgCategory BXC03CAB176B002010284135NHSA
Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized国药准字H202549212ml:1mgCategory BXC03CAB176B002010284534NHSA
Chengdu Li Er Pharma Co., Ltd. romanized国药准字H202560364ml:2mgCategory BXC03CAB176B002010284779NHSA
Shenzhen Ge Lai En Biopharmaceuticals Technology Co., Ltd. romanized国药准字H202553334ml:1mgCategory BXC03CAB176B002010285074NHSA
Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized国药准字H202544562ml∶0.5mgCategory BXC03CAB176B002010285135NHSA
Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized国药准字H202560324ml:2mgCategory BXC03CAB176B002010285170NHSA
Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized国药准字H202645152ml:1mgCategory BXC03CAB176B002010285467NHSA
Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized国药准字H202563002ml:1mgCategory BXC03CAB176B002010285482NHSA
Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized国药准字H202645142ml:0.5mgCategory BXC03CAB176B002010285560NHSA
Xi Nan Pharma Co., Ltd. romanized国药准字H500214612ml:0.5mgCategory BXC03CAB176B002010300978NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202637232ml:1mgCategory BXC03CAB176B002010302763NHSA
Shandong Fang Ming Pharma Group Co., Ltd. romanized国药准字H202652134ml:2mgCategory BXC03CAB176B002010304083NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H202639514ml:1mgCategory BXC03CAB176B002010304127NHSA
Gansu Cheng Ji Bio Pharma Co., Ltd. romanized国药准字H201630982ml:0.5mgCategory BXC03CAB176B002010307698NHSA
Shenzhen Ge Lai En Biopharmaceuticals Technology Co., Ltd. romanized国药准字H202553334ml:1mgCategory BXC03CAB176B002010385074NHSA
Shandong Fang Ming Pharma Group Co., Ltd. romanized国药准字H202652134ml:2mgCategory BXC03CAB176B002010404083NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H202639514ml:1mgCategory BXC03CAB176B002010404127NHSA
Liaoning Yu Huang Pharma Co., Ltd. romanized国药准字H200834992ml:0.5mgCategory BXC03CAB176B002020101247NHSA
Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized国药准字H202647352ml:1mgCategory BXC03CAB176B002020101495NHSA
Hubei Jin Yao Pharma Co., Ltd. romanized国药准字H200570232ml:0.5mgCategory BXC03CAB176B002020101866NHSA
Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized国药准字H202690951ml:0.5mgCategory BXC03CAB176B002020102087NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202644401ml:0.5mgCategory BXC03CAB176B002020102763NHSA
Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized国药准字H202690771ml:0.5mgCategory BXC03CAB176B002020103216NHSA
Fuzhou Hai Wang Fu Yao Pharmaceutical Co., Ltd. romanized国药准字H350204602ml:0.5mgCategory BXC03CAB176B002020104827NHSA
Gui Lin Nan Yao Co., Ltd. romanized国药准字H200572252ml:1mgCategory BXC03CAB176B002020105206NHSA
Suzhou Te Rui Pharma Co., Ltd. romanized国药准字H202630661ml : 0.5mgCategory BXC03CAB176B002020110121NHSA
Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized国药准字H202691291ml:0.5mgCategory BXC03CAB176B002020183960NHSA
Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized国药准字H202549204ml:2mgCategory BXC03CAB176B002020184534NHSA
Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized国药准字H202644791ml:0.5mgCategory BXC03CAB176B002020184954NHSA
Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized国药准字H202563014ml:2mgCategory BXC03CAB176B002020185482NHSA
Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized国药准字H202647352ml:1mgCategory BXC03CAB176B002020201495NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202644401ml:0.5mgCategory BXC03CAB176B002020202763NHSA
Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized国药准字H202691291ml:0.5mgCategory BXC03CAB176B002020283960NHSA
Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized国药准字H202549204ml:2mgCategory BXC03CAB176B002020284534NHSA
Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized国药准字H202563014ml:2mgCategory BXC03CAB176B002020285482NHSA
Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized国药准字H202647352ml:1mgCategory BXC03CAB176B002020301495NHSA
Hubei Jin Yao Pharma Co., Ltd. romanized国药准字H200570232ml:0.5mgCategory BXC03CAB176B002020301866NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202644401ml:0.5mgCategory BXC03CAB176B002020302763NHSA
Gui Lin Nan Yao Co., Ltd. romanized国药准字H200572252ml:1mgCategory BXC03CAB176B002020305206NHSA
Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized国药准字H202647352ml:1mgCategory BXC03CAB176B002020401495NHSA
Gui Lin Nan Yao Co., Ltd. romanized国药准字H200572252ml:1mgCategory BXC03CAB176B002020405206NHSA
Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized国药准字H202560324ml:2mgCategory BXC03CAB176B002010385170NHSA

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: 13 filings and 9 distinct first applicants.

Generic 11 · Supplement 2

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jiangsu Fu Bang Pharma Co., Ltd. romanizedCYHS2600530Generic2026/02/26Not stated by sourceCDE
Jiangsu Fu Bang Pharma Co., Ltd. romanizedCYHS2600529Generic2026/02/26Not stated by sourceCDE
Dan Dong Yi Chuang Pharma Co., Ltd. romanizedCYHS2601384Generic2026/06/11Not stated by sourceCDE
Dan Dong Yi Chuang Pharma Co., Ltd. romanizedCYHS2601382Generic2026/06/11Not stated by sourceCDE
Wuhan Hai Te Biopharmaceutical Co., Ltd. romanizedCYHB2601065Supplement2026/06/05Not stated by sourceCDE
Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanizedCYHS2601212Generic2026/05/29Not stated by sourceCDE
Fuzhou Hai Wang Fu Yao Pharmaceutical Co., Ltd. romanizedCYHB2650108Supplement2026/04/30Not stated by sourceCDE
Shandong Yi Jian Pharma Co., Ltd. romanizedCYHS2503579Generic2025/09/30Not stated by sourceCDE
Shandong Yi Jian Pharma Co., Ltd. romanizedCYHS2503578Generic2025/09/30Not stated by sourceCDE
Hainan Pu Li Pharmaceutical Co., Ltd. romanizedCYHS2502591Generic2025/07/18Not stated by sourceCDE
Shandong Hui Cheng Pharma Co., Ltd. romanizedCYHS2501471Generic2025/04/17Not stated by sourceCDE
Chongqing Bo Teng Pharma Co., Ltd. romanizedCYHS2501196Generic2025/03/27Not stated by sourceCDE
Wuhan Hai Te Biopharmaceutical Co., Ltd. romanizedCYHS2403001Generic2024/09/11Not stated by sourceCDE
New generic filings in 2026

Loaded records: 5 filings and 3 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jiangsu Fu Bang Pharma Co., Ltd. romanizedCYHS2600530Generic2026/02/26Not stated by sourceCDE
Jiangsu Fu Bang Pharma Co., Ltd. romanizedCYHS2600529Generic2026/02/26Not stated by sourceCDE
Dan Dong Yi Chuang Pharma Co., Ltd. romanizedCYHS2601384Generic2026/06/11Not stated by sourceCDE
Dan Dong Yi Chuang Pharma Co., Ltd. romanizedCYHS2601382Generic2026/06/11Not stated by sourceCDE
Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanizedCYHS2601212Generic2026/05/29Not stated by sourceCDE
API registrations

Non-component matches: 24 companies with A status and 3 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
布美他尼 · No verified English nameYi Chang Tian Rui Biopharmaceuticals Co., Ltd. romanizedY20260000184IExact ingredient2026/04/23CDE
布美他尼 · No verified English nameZhejiang Sai Mo Pharmaceutical Co., Ltd. romanizedY20240000927AExact ingredient2026/07/13CDE
布美他尼 · No verified English nameXu Bi Di Pharma (Cang Zhou) Co., Ltd. romanizedY20240001294AExact ingredient2026/05/07CDE
布美他尼 · No verified English nameHebei Guo Long Pharmaceutical Co., Ltd. romanizedY20240001211AExact ingredient2026/07/15CDE
布美他尼 · No verified English nameHainan Pu Li Pharmaceutical Co., Ltd. romanizedY20240001076AExact ingredient2026/04/01CDE
布美他尼 · No verified English nameShandong Fang Ming Pharma Group Co., Ltd. romanizedY20240000859AExact ingredient2026/04/21CDE
布美他尼 · No verified English nameJiu Quan Da De Li Pharmaceutical Co., Ltd. romanizedY20240000936AExact ingredient2026/07/01CDE
布美他尼 · No verified English nameHangzhou Ao Sai Nuo Bio Technology Co., Ltd. romanizedY20240000761AExact ingredient2026/03/17CDE
布美他尼 · No verified English nameFujian Nan Fang Pharmaceutical Co., Ltd. romanizedY20240000807AExact ingredient2026/01/08CDE
布美他尼 · No verified English nameShandong Chen Long Pharma Co., Ltd. romanizedY20240000775AExact ingredient2026/06/23CDE
布美他尼 · No verified English nameFujian Nan Fang Pharmaceutical Co., Ltd. romanizedY20240000623IExact ingredient2024/08/05CDE
布美他尼 · No verified English nameSuzhou Li Xin Pharmaceutical Co., Ltd. romanizedY20240000515AExact ingredient2025/11/26CDE
布美他尼 · No verified English nameOLON S.P.A.Y20240000359AExact ingredient2025/12/05CDE
布美他尼 · No verified English nameZhejiang Hao Hua Pharmaceutical Co., Ltd. romanizedY20240000188AExact ingredient2025/05/28CDE
布美他尼 · No verified English nameAnhui Heng Xing Pharmaceutical Co., Ltd. romanizedY20230001167AExact ingredient2025/07/01CDE
布美他尼 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20230001090AExact ingredient2025/07/18CDE
布美他尼 · No verified English nameINDUSTRIALE CHIMICA S.R.L.Y20230000563AExact ingredient2026/09/13CDE
布美他尼 · No verified English nameJiangsu Yun Yang Group Pharma Co., Ltd. romanizedY20230000614AExact ingredient2024/11/07CDE
布美他尼 · No verified English nameSichuan Qing Mu Pharmaceutical Co., Ltd. romanizedY20230000354AExact ingredient2026/03/03CDE
布美他尼 · No verified English nameSu Zhou Yi Fan Pharma Co., Ltd. romanizedY20230000386AExact ingredient2025/06/07CDE
布美他尼 · No verified English nameZhongshan Wanhan Pharmaceuticals Co., Ltd.Y20230000272AExact ingredient2026/08/15CDE
布美他尼 · No verified English nameChengdu Xin Heng Chuang Pharma Co., Ltd. romanizedY20220001296AExact ingredient2026/01/22CDE
布美他尼 · No verified English nameSolara Active Pharma Sciences LimitedY20210001128IExact ingredient2022/02/23CDE
布美他尼 · No verified English nameDan Dong Yi Chuang Pharma Co., Ltd. romanizedY20190007367AExact ingredient—CDE
布美他尼 · No verified English nameGui Lin Nan Yao Co., Ltd. romanizedY20190004090AExact ingredient2025/01/18CDE
布美他尼 · No verified English nameHainan Wu Ren Pharmaceutical Co., Ltd. romanizedY20190002887AExact ingredient2024/09/05CDE
布美他尼 · No verified English nameNingbo Da Hong Ying Pharma Co., Ltd. romanizedY20190002459AExact ingredient2025/01/03CDE

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. 2026/11/09Notification delivery

    Jiangsu Ming Yuan Pharma Co., Ltd. romanized

    CYHS2502623

    Fact date: 2026/11/09 (Publication date) · Publication date: 2026/11/09 · Site observation date: 2026/11/09

    Notification delivered; the specific outcome remains to be checked.

    View source · Table row 4 ↗
  2. 2026/11/07No longer listed under review

    Hefei Yuan Feng Shun Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized

    CYHS2501389

    Fact date: 2026/11/07 · Site observation date: 2026/11/07

    Accepted: 2025/04/10

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  3. 2026/11/06No longer listed under review

    Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized

    CYHS2500702

    Fact date: 2026/11/06 · Site observation date: 2026/11/06

    Accepted: 2025/02/12

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  4. 2026/11/06No longer listed under review

    Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized

    CYHS2500701

    Fact date: 2026/11/06 · Site observation date: 2026/11/06

    Accepted: 2025/02/12

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  5. 2026/10/24No longer listed under review

    Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized

    CYHS2501608

    Fact date: 2026/10/24 · Site observation date: 2026/10/24

    Accepted: 2025/04/29

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  6. 2026/10/20Marketing application approved

    Chengdu Kang Tai Yuan Pharmaceuticals Technology Co., Ltd. romanized

    CYHS2501821 · 国药准字H20266291

    Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03

    The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.

    View source · Table row 66 ↗

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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