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As of 13 November 2026, for Bromhexine Hydrochloride Oral Solution, 22 applications are listed as under review at China's CDE; 9 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 0 holders.
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.
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.
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 |
|---|---|---|---|---|---|
| Beijing SL Pharmaceutical Co., Ltd. | 国药准字H20266095 | 40ml:80mg | Category B | XR05CBX169X001010100148 | NHSA |
| Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 国药准字H20256424 | 40ml:80mg | Category B | XR05CBX169X001010100548 | NHSA |
| Jiangxi Yi You Pharma Co., Ltd. romanized | 国药准字H20223978 | 40ml:80mg | Category B | XR05CBX169X001010104293 | NHSA |
| Anhui Xin Shi Ji Pharma Co., Ltd. romanized | 国药准字H20244610 | 100ml:0.2g | Category B | XR05CBX169X001010104360 | NHSA |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | 国药准字H20263283 | 125ml:0.1g | Category B | XR05CBX169X001010105816 | NHSA |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20254393 | 100ml:0.2g | Category B | XR05CBX169X001010180651 | NHSA |
| Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 国药准字H20265839 | 40ml:80mg | Category B | XR05CBX169X001010181251 | NHSA |
| Jiangxi Yi You Pharma Co., Ltd. romanized | 国药准字H20243131 | 100ml:0.2g | Category B | XR05CBX169X001010181644 | NHSA |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H20243004 | 100ml:0.2g | Category B | XR05CBX169X001010183033 | NHSA |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20256371 | 100ml:0.2g | Category B | XR05CBX169X001010183611 | NHSA |
| Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20255497 | 40ml:80mg | Category B | XR05CBX169X001010183686 | NHSA |
| Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized | 国药准字H20244506 | 60ml:48mg | Category B | XR05CBX169X001010183719 | NHSA |
| Jiangsu Kai Yuan Pharma Co., Ltd. romanized | 国药准字H20263779 | 100ml:0.2g | Category B | XR05CBX169X001010183955 | NHSA |
| Zhejiang Huan Ling Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249807 | 100ml:0.16g | Category B | XR05CBX169X001010184239 | NHSA |
| Henan Shang Heng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254828 | 100ml:0.2g | Category B | XR05CBX169X001010184435 | NHSA |
| Hubei Min Kang Pharma Group Co., Ltd. romanized | 国药准字H20265193 | 100ml:0.2g | Category B | XR05CBX169X001010184564 | NHSA |
| Hunan Qian Jin Xie Li Pharma Co., Ltd. romanized | 国药准字H20254457 | 100ml:0.2g | Category B | XR05CBX169X001010184983 | NHSA |
| Hebei Hui De Xu Sheng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20265590 | 100ml:0.2g | Category B | XR05CBX169X001010184987 | NHSA |
| Sichuan Tian Xing Hui Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254726 | 100ml:0.2g | Category B | XR05CBX169X001010185049 | NHSA |
| Jiangxi Yi You Pharma Co., Ltd. romanized | 国药准字H20223978 | 40ml:80mg | Category B | XR05CBX169X001010204293 | NHSA |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H20243004 | 100ml:0.2g | Category B | XR05CBX169X001010283033 | NHSA |
| Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized | 国药准字H20244506 | 60ml:48mg | Category B | XR05CBX169X001010283719 | NHSA |
| Hainan Kang Cheng Pharma Co., Ltd. romanized | 国药准字H20254405 | 100ml:0.2g | Category B | XR05CBX169X001010284160 | NHSA |
| Jiangxi Yi You Pharma Co., Ltd. romanized | 国药准字H20223978 | 40ml:80mg | Category B | XR05CBX169X001010304293 | NHSA |
| Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 国药准字H20256425 | 100ml:0.2g | Category B | XR05CBX169X001020100548 | NHSA |
| Anhui Xin Shi Ji Pharma Co., Ltd. romanized | 国药准字H20269135 | 4ml:8mg | Category B | XR05CBX169X001020104360 | NHSA |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | 国药准字H20263284 | 200ml:0.16g | Category B | XR05CBX169X001020105816 | NHSA |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20254392 | 40ml:80mg | Category B | XR05CBX169X001020180651 | NHSA |
| Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized | 国药准字H20244507 | 100ml:0.16g | Category B | XR05CBX169X001020183719 | NHSA |
| Zhejiang Huan Ling Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253024 | 60ml:48mg | Category B | XR05CBX169X001020184239 | NHSA |
| Henan Shang Heng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254829 | 40ml:80mg | Category B | XR05CBX169X001020184435 | NHSA |
| Hubei Min Kang Pharma Group Co., Ltd. romanized | 国药准字H20265194 | 40ml:80mg | Category B | XR05CBX169X001020184564 | NHSA |
| Hebei Hui De Xu Sheng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20265591 | 40ml:80mg | Category B | XR05CBX169X001020184987 | NHSA |
| Anhui Xin Shi Ji Pharma Co., Ltd. romanized | 国药准字H20269135 | 4ml:8mg | Category B | XR05CBX169X001020204360 | NHSA |
| Henan Shang Heng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254829 | 40ml:80mg | Category B | XR05CBX169X001020284435 | NHSA |
| Henan Shang Heng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254829 | 40ml:80mg | Category B | XR05CBX169X001020384435 | NHSA |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20263333 | 200ml:160mg | Category B | 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
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 |
|---|---|---|---|---|---|
| Jiangsu Shen Hua Pharma Co., Ltd. romanized | CYHS2601379 | Generic | 2026/06/11 | Not stated by source | CDE |
| Sichuan Qun Le Kang Pharma Co., Ltd. romanized; Jiangxi He Ying Pharma Co., Ltd. romanized | CYHS2602035 | Generic | 2026/08/17 | Not stated by source | CDE |
| Hebei Shan Mu Shi Pharma Co., Ltd. romanized | CYHS2601664 | Generic | 2026/07/13 | Not stated by source | CDE |
| Hebei Shan Mu Shi Pharma Co., Ltd. romanized | CYHS2601663 | Generic | 2026/07/13 | Not stated by source | CDE |
| Guangdong Nan Guo Pharma Co., Ltd. romanized | CYHS2601507 | Generic | 2026/06/26 | Not stated by source | CDE |
| Guangdong Nan Guo Pharma Co., Ltd. romanized | CYHS2601506 | Generic | 2026/06/26 | Not stated by source | CDE |
| Anhui Huan Qiu Pharma Co., Ltd. romanized | CYHS2601058 | Generic | 2026/05/09 | Not stated by source | CDE |
| Guizhou Qian Yao Group Pharmaceutical Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2600829 | Generic | 2026/04/10 | Not stated by source | CDE |
| Zhejiang Ling Chuang You Pin Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2600665 | Generic | 2026/03/14 | Not stated by source | CDE |
| Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized | CYHS2600568 | Generic | 2026/02/27 | Not stated by source | CDE |
| Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Shandong Jian Dao Pharmaceutical Co., Ltd. romanized | CYHS2600256 | Generic | 2026/01/22 | Not stated by source | CDE |
| Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Shandong Jian Dao Pharmaceutical Co., Ltd. romanized | 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 · No verified English name | Hubei Mei Lin Pharma Co., Ltd. romanized | Y20240001175 | A | Exact ingredient | 2026/08/13 | CDE |
| 盐酸溴己新 · No verified English name | Yao Kang Zhong Tuo (Jiangsu) Pharmaceuticals Technology Co., Ltd. romanized | Y20240001095 | I | Exact ingredient | 2026/01/08 | CDE |
| 盐酸溴己新 · No verified English name | Hubei Wu Shi Pharma Co., Ltd. romanized | Y20230000895 | A | Exact ingredient | 2026/09/16 | CDE |
| 盐酸溴己新 · No verified English name | Bai Yun Shandong Tai Shang Qiu Pharma Co., Ltd. romanized | Y20230000613 | A | Exact ingredient | 2026/01/23 | CDE |
| 盐酸溴己新 · No verified English name | Shandong Qidu Pharmaceutical Co., Ltd. | Y20230000542 | A | Exact ingredient | 2025/12/03 | CDE |
| 盐酸溴己新 · No verified English name | Wu Yi Ci Hang Pharma Co., Ltd. romanized | Y20220000824 | A | Exact ingredient | 2025/09/24 | CDE |
| 盐酸溴己新 · No verified English name | Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized | Y20220000708 | A | Exact ingredient | 2026/01/22 | CDE |
| 盐酸溴己新 · No verified English name | VEN PETROCHEM & PHARMA (INDIA) PVT LTD. | Y20210000882 | A | Exact ingredient | 2024/07/26 | CDE |
| 盐酸溴己新 · No verified English name | Jiangxi Bo Ya Xin He Pharmaceutical Co., Ltd. romanized | Y20200000365 | A | Exact ingredient | 2026/05/06 | CDE |
| 盐酸溴己新 · No verified English name | Shanghai Xu Dong Hai Pu Nan Tong Pharma Co., Ltd. romanized | Y20190021429 | A | Exact ingredient | 2026/03/21 | CDE |
| 盐酸溴己新 · No verified English name | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | Y20190000846 | A | Exact ingredient | 2026/07/31 | CDE |
| 盐酸溴己新 · No verified English name | Hunan Er Kang Pharmaceutical Co., Ltd. romanized | Y20190008448 | A | Exact ingredient | 2025/02/08 | CDE |
| 盐酸溴己新 · No verified English name | Jiangxi Yi You Pharma Co., Ltd. romanized | Y20190008344 | A | Exact ingredient | 2024/06/04 | CDE |
| 盐酸溴己新 · No verified English name | Tai Cang Pharmaceutical Factory romanized | Y20190007187 | A | Exact ingredient | 2024/03/29 | CDE |
| 盐酸溴己新 · No verified English name | Zhejiang Le Pu Pharma Co., Ltd. romanized | Y20190004465 | A | Exact ingredient | 2025/05/01 | CDE |
| 盐酸溴己新 · No verified English name | Hua Run Shuang He Pharma Co., Ltd. romanized | Y20190003977 | A | Exact ingredient | — | CDE |
| 盐酸溴己新 · No verified English name | Wan Bang De Pharmaceutical Group Co., Ltd. romanized | Y20190003549 | A | Exact ingredient | 2025/06/19 | CDE |
| 盐酸溴己新 · No verified English name | Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized | Y20180001038 | A | Exact ingredient | 2026/01/09 | CDE |
| 盐酸溴己新 · No verified English name | Jiangsu Run An Pharmaceutical Co., Ltd. romanized | Y20170001511 | A | Exact ingredient | 2026/09/12 | CDE |
| 盐酸溴己新 · No verified English name | Hebei Chuang Jian Pharma Co., Ltd. romanized | Y20170000639 | A | Exact ingredient | 2024/02/23 | CDE |
| 盐酸溴己新 · No verified English name | BIDACHEM SPA | Y20170000561 | I | Exact ingredient | — | CDE |
| 盐酸溴己新 · No verified English name | Hebei Guo Long Pharmaceutical Co., Ltd. romanized | 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: 2026/11/13 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.
-
2026/11/05No longer listed under review
Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
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
Hunan Pu Dao Pharmaceuticals Technology Co., Ltd. romanized
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
Sichuan Qun Le Kang Pharma Co., Ltd. romanized; Jiangxi He Ying Pharma Co., Ltd. romanized
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: 2026/11/13 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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