Monthly
US$200
Billed every month
Bromhexine Hydrochloride Oral Solution(盐酸溴己新口服溶液)
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 1 applicationNo longer listed under review: 1 application
Current coverage may be incomplete
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.
Catalogue holders0View records ↓
Under-review filings22View records ↓
This year’s generic filers9View records ↓
NHSA approval numbers30View records ↓
API companies with A status19View records ↓
Chemical-drug catalogue
Loaded records: 0 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 0 in the new chemical-registration-classification generic category. Category counts may overlap.
| Marketing authorization holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| No matching records were found in the currently loaded source data; coverage dates are listed below. | ||||||
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: 30 distinct approval numbers and 19 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 北京双鹭药业股份有限公司 | 国药准字H20266095 | 40ml:80mg | Category B (乙) | XR05CBX169X001010100148 | NHSA |
| 广州大光制药有限公司 | 国药准字H20256424 | 40ml:80mg | Category B (乙) | XR05CBX169X001010100548 | NHSA |
| 江西亿友药业有限公司 | 国药准字H20223978 | 40ml:80mg | Category B (乙) | XR05CBX169X001010104293 | NHSA |
| 安徽新世纪药业有限公司 | 国药准字H20244610 | 100ml:0.2g | Category B (乙) | XR05CBX169X001010104360 | NHSA |
| 海南斯达制药有限公司 | 国药准字H20263283 | 125ml:0.1g | Category B (乙) | XR05CBX169X001010105816 | NHSA |
| 福元药业有限公司 | 国药准字H20254393 | 100ml:0.2g | Category B (乙) | XR05CBX169X001010180651 | NHSA |
| 海南广升誉制药有限公司 | 国药准字H20265839 | 40ml:80mg | Category B (乙) | XR05CBX169X001010181251 | NHSA |
| 江西亿友药业有限公司 | 国药准字H20243131 | 100ml:0.2g | Category B (乙) | XR05CBX169X001010181644 | NHSA |
| 仁合益康集团有限公司 | 国药准字H20243004 | 100ml:0.2g | Category B (乙) | XR05CBX169X001010183033 | NHSA |
| 江苏广承药业有限公司 | 国药准字H20256371 | 100ml:0.2g | Category B (乙) | XR05CBX169X001010183611 | NHSA |
| 知和(山东)大药厂有限公司 | 国药准字H20255497 | 40ml:80mg | Category B (乙) | XR05CBX169X001010183686 | NHSA |
| 合肥国药诺和药业有限公司 | 国药准字H20244506 | 60ml:48mg | Category B (乙) | XR05CBX169X001010183719 | NHSA |
| 江苏开元药业有限公司 | 国药准字H20263779 | 100ml:0.2g | Category B (乙) | XR05CBX169X001010183955 | NHSA |
| 浙江寰领医药科技有限公司 | 国药准字H20249807 | 100ml:0.16g | Category B (乙) | XR05CBX169X001010184239 | NHSA |
| 河南上恒医药科技有限公司 | 国药准字H20254828 | 100ml:0.2g | Category B (乙) | XR05CBX169X001010184435 | NHSA |
| 湖北民康药业集团有限公司 | 国药准字H20265193 | 100ml:0.2g | Category B (乙) | XR05CBX169X001010184564 | NHSA |
| 湖南千金协力药业有限公司 | 国药准字H20254457 | 100ml:0.2g | Category B (乙) | XR05CBX169X001010184983 | NHSA |
| 河北汇德旭盛医药科技有限公司 | 国药准字H20265590 | 100ml:0.2g | Category B (乙) | XR05CBX169X001010184987 | NHSA |
| 四川天杏汇医药科技有限公司 | 国药准字H20254726 | 100ml:0.2g | Category B (乙) | XR05CBX169X001010185049 | NHSA |
| 江西亿友药业有限公司 | 国药准字H20223978 | 40ml:80mg | Category B (乙) | XR05CBX169X001010204293 | NHSA |
| 仁合益康集团有限公司 | 国药准字H20243004 | 100ml:0.2g | Category B (乙) | XR05CBX169X001010283033 | NHSA |
| 合肥国药诺和药业有限公司 | 国药准字H20244506 | 60ml:48mg | Category B (乙) | XR05CBX169X001010283719 | NHSA |
| 海南康成药业有限公司 | 国药准字H20254405 | 100ml:0.2g | Category B (乙) | XR05CBX169X001010284160 | NHSA |
| 江西亿友药业有限公司 | 国药准字H20223978 | 40ml:80mg | Category B (乙) | XR05CBX169X001010304293 | NHSA |
| 广州大光制药有限公司 | 国药准字H20256425 | 100ml:0.2g | Category B (乙) | XR05CBX169X001020100548 | NHSA |
| 安徽新世纪药业有限公司 | 国药准字H20269135 | 4ml:8mg | Category B (乙) | XR05CBX169X001020104360 | NHSA |
| 海南斯达制药有限公司 | 国药准字H20263284 | 200ml:0.16g | Category B (乙) | XR05CBX169X001020105816 | NHSA |
| 福元药业有限公司 | 国药准字H20254392 | 40ml:80mg | Category B (乙) | XR05CBX169X001020180651 | NHSA |
| 合肥国药诺和药业有限公司 | 国药准字H20244507 | 100ml:0.16g | Category B (乙) | XR05CBX169X001020183719 | NHSA |
| 浙江寰领医药科技有限公司 | 国药准字H20253024 | 60ml:48mg | Category B (乙) | XR05CBX169X001020184239 | NHSA |
| 河南上恒医药科技有限公司 | 国药准字H20254829 | 40ml:80mg | Category B (乙) | XR05CBX169X001020184435 | NHSA |
| 湖北民康药业集团有限公司 | 国药准字H20265194 | 40ml:80mg | Category B (乙) | XR05CBX169X001020184564 | NHSA |
| 河北汇德旭盛医药科技有限公司 | 国药准字H20265591 | 40ml:80mg | Category B (乙) | XR05CBX169X001020184987 | NHSA |
| 安徽新世纪药业有限公司 | 国药准字H20269135 | 4ml:8mg | Category B (乙) | XR05CBX169X001020204360 | NHSA |
| 河南上恒医药科技有限公司 | 国药准字H20254829 | 40ml:80mg | Category B (乙) | XR05CBX169X001020284435 | NHSA |
| 河南上恒医药科技有限公司 | 国药准字H20254829 | 40ml:80mg | Category B (乙) | XR05CBX169X001020384435 | NHSA |
| 福元药业有限公司 | 国药准字H20263333 | 200ml:160mg | Category B (乙) | XR05CBX169X001030180651 | NHSA |
Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.
Current under-review applications
Loaded records: 22 filings and 19 distinct first applicants.
Generic 22
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 石家庄四药有限公司;湖南科伦制药有限公司 | CYHS2502586 | Generic | 2025/07/18 | Not stated by source | CDE |
| 江苏欧歌制药有限公司 | CYHS2501110 | Generic | 2025/03/19 | Not stated by source | CDE |
| 江苏神华药业有限公司 | CYHS2601379 | Generic | 2026/06/11 | Not stated by source | CDE |
| 四川群乐康药业有限公司;江西和盈药业有限公司 | CYHS2602035 | Generic | 2026/08/17 | Not stated by source | CDE |
| 河北山姆士药业有限公司 | CYHS2601664 | Generic | 2026/07/13 | Not stated by source | CDE |
| 河北山姆士药业有限公司 | CYHS2601663 | Generic | 2026/07/13 | Not stated by source | CDE |
| 广东南国药业有限公司 | CYHS2601507 | Generic | 2026/06/26 | Not stated by source | CDE |
| 广东南国药业有限公司 | CYHS2601506 | Generic | 2026/06/26 | Not stated by source | CDE |
| 安徽环球药业股份有限公司 | CYHS2601058 | Generic | 2026/05/09 | Not stated by source | CDE |
| 贵州黔药集团制药有限公司;湖南九典制药股份有限公司 | CYHS2600829 | Generic | 2026/04/10 | Not stated by source | CDE |
| 浙江领创优品药业有限公司;浙江赛默制药有限公司 | CYHS2600665 | Generic | 2026/03/14 | Not stated by source | CDE |
| 湖北长联杜勒制药有限公司 | CYHS2600568 | Generic | 2026/02/27 | Not stated by source | CDE |
| 石家庄凯达生物工程有限公司;山东简道制药有限公司 | CYHS2600256 | Generic | 2026/01/22 | Not stated by source | CDE |
| 石家庄凯达生物工程有限公司;山东简道制药有限公司 | CYHS2600255 | Generic | 2026/01/22 | Not stated by source | CDE |
| 天大药业（珠海）有限公司 | CYHS2503712 | Generic | 2025/10/16 | Not stated by source | CDE |
| 大连百利天华制药有限公司;山东简道制药有限公司 | CYHS2503374 | Generic | 2025/09/12 | Not stated by source | CDE |
| 浙江百代医药科技有限公司;浙江赛默制药有限公司 | CYHS2503336 | Generic | 2025/09/09 | Not stated by source | CDE |
| 江西科为制药有限公司;江西和盈药业有限公司 | CYHS2502813 | Generic | 2025/08/05 | Not stated by source | CDE |
| 珠海横琴国研医药科技有限公司;合肥诚志生物制药有限公司 | CYHS2502768 | Generic | 2025/08/01 | Not stated by source | CDE |
| 合肥远志医药科技开发有限公司;安徽新世纪药业有限公司 | CYHS2502677 | Generic | 2025/07/24 | Not stated by source | CDE |
| 岳阳新华达制药有限公司 | CYHS2502131 | Generic | 2025/06/14 | Not stated by source | CDE |
| 湖南九典制药股份有限公司 | CYHS2502016 | Generic | 2025/06/07 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 12 filings and 9 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏神华药业有限公司 | CYHS2601379 | Generic | 2026/06/11 | Not stated by source | CDE |
| 四川群乐康药业有限公司;江西和盈药业有限公司 | CYHS2602035 | Generic | 2026/08/17 | Not stated by source | CDE |
| 河北山姆士药业有限公司 | CYHS2601664 | Generic | 2026/07/13 | Not stated by source | CDE |
| 河北山姆士药业有限公司 | CYHS2601663 | Generic | 2026/07/13 | Not stated by source | CDE |
| 广东南国药业有限公司 | CYHS2601507 | Generic | 2026/06/26 | Not stated by source | CDE |
| 广东南国药业有限公司 | CYHS2601506 | Generic | 2026/06/26 | Not stated by source | CDE |
| 安徽环球药业股份有限公司 | CYHS2601058 | Generic | 2026/05/09 | Not stated by source | CDE |
| 贵州黔药集团制药有限公司;湖南九典制药股份有限公司 | CYHS2600829 | Generic | 2026/04/10 | Not stated by source | CDE |
| 浙江领创优品药业有限公司;浙江赛默制药有限公司 | CYHS2600665 | Generic | 2026/03/14 | Not stated by source | CDE |
| 湖北长联杜勒制药有限公司 | CYHS2600568 | Generic | 2026/02/27 | Not stated by source | CDE |
| 石家庄凯达生物工程有限公司;山东简道制药有限公司 | CYHS2600256 | Generic | 2026/01/22 | Not stated by source | CDE |
| 石家庄凯达生物工程有限公司;山东简道制药有限公司 | CYHS2600255 | Generic | 2026/01/22 | Not stated by source | CDE |
API registrations
Non-component matches: 19 companies with A status and 2 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 盐酸溴己新 | 湖北美林药业有限公司 | Y20240001175 | A | Exact ingredient | 2026/08/13 | CDE |
| 盐酸溴己新 | 药康众拓（江苏）医药科技有限公司 | Y20240001095 | I | Exact ingredient | 2026/01/08 | CDE |
| 盐酸溴己新 | 湖北午时药业股份有限公司 | Y20230000895 | A | Exact ingredient | 2026/09/16 | CDE |
| 盐酸溴己新 | 白云山东泰商丘药业有限公司 | Y20230000613 | A | Exact ingredient | 2026/01/23 | CDE |
| 盐酸溴己新 | 山东齐都药业有限公司 | Y20230000542 | A | Exact ingredient | 2025/12/03 | CDE |
| 盐酸溴己新 | 武邑慈航药业有限公司 | Y20220000824 | A | Exact ingredient | 2025/09/24 | CDE |
| 盐酸溴己新 | 成都新恒创药业有限公司 | Y20220000708 | A | Exact ingredient | 2026/01/22 | CDE |
| 盐酸溴己新 | VEN PETROCHEM & PHARMA (INDIA) PVT LTD. | Y20210000882 | A | Exact ingredient | 2024/07/26 | CDE |
| 盐酸溴己新 | 江西博雅欣和制药有限公司 | Y20200000365 | A | Exact ingredient | 2026/05/06 | CDE |
| 盐酸溴己新 | 上海旭东海普南通药业有限公司 | Y20190021429 | A | Exact ingredient | 2026/03/21 | CDE |
| 盐酸溴己新 | 广州一品红制药有限公司 | Y20190000846 | A | Exact ingredient | 2026/07/31 | CDE |
| 盐酸溴己新 | 湖南尔康制药股份有限公司 | Y20190008448 | A | Exact ingredient | 2025/02/08 | CDE |
| 盐酸溴己新 | 江西亿友药业有限公司 | Y20190008344 | A | Exact ingredient | 2024/06/04 | CDE |
| 盐酸溴己新 | 太仓制药厂 | Y20190007187 | A | Exact ingredient | 2024/03/29 | CDE |
| 盐酸溴己新 | 浙江乐普药业股份有限公司 | Y20190004465 | A | Exact ingredient | 2025/05/01 | CDE |
| 盐酸溴己新 | 华润双鹤药业股份有限公司 | Y20190003977 | A | Exact ingredient | — | CDE |
| 盐酸溴己新 | 万邦德制药集团有限公司 | Y20190003549 | A | Exact ingredient | 2025/06/19 | CDE |
| 盐酸溴己新 | 成都新恒创药业有限公司 | Y20180001038 | A | Exact ingredient | 2026/01/09 | CDE |
| 盐酸溴己新 | 江苏润安制药有限公司 | Y20170001511 | A | Exact ingredient | 2026/09/12 | CDE |
| 盐酸溴己新 | 河北创健药业有限公司 | Y20170000639 | A | Exact ingredient | 2024/02/23 | CDE |
| 盐酸溴己新 | BIDACHEM SPA | Y20170000561 | I | Exact ingredient | — | CDE |
| 盐酸溴己新 | 河北国龙制药有限公司 | Y20170000261 | A | Exact ingredient | 2023/07/02 | CDE |
A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.
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.
-
2026/11/05No longer listed under review
北京民康百草医药科技有限公司;湖南九典制药股份有限公司
CYHS2501730
Fact date: 2026/11/05 · Site observation date: 2026/11/05
Accepted: 2025/05/14
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/26Marketing application approved
湖南普道医药技术有限公司
CYHS2500497 · 国药准字H20266390
Fact date: 2026/10/26 · Publication date: 2026/10/27 · 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 31 ↗ -
2026/08/17Accepted
四川群乐康药业有限公司;江西和盈药业有限公司
CYHS2602035
Fact date: 2026/08/17 · 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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