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乙酰半胱氨酸片
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 2 applications
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 holders3View records ↓
Under-review filings8View records ↓
This year’s generic filers6View records ↓
NHSA approval numbers6View records ↓
API companies with A status12View records ↓
Chemical-drug catalogue
Loaded records: 3 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 3 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 |
|---|---|---|---|---|---|---|
| 广东泰来润至医药科技有限公司 | 广州玻思韬控释药业有限公司 | 国药准字H20265302 | 2026/07/21 | 0.6g | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 北京福元医药股份有限公司 | 北京福元医药股份有限公司 | 国药准字H20263935 | 2026/04/14 | 0.6g | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 杭州沐源生物医药科技股份有限公司 | 成都通德药业有限公司 | 国药准字H20263617 | 2026/03/17 | 0.6g | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
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: 6 distinct approval numbers and 5 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 北京福元医药股份有限公司 | 国药准字H20263935 | 0.6g | Category B (乙) | XR05CBY116A001010100177 | NHSA |
| 海南赛立克药业有限公司 | 国药准字H20265743 | 0.6g | Category B (乙) | XR05CBY116A001010105805 | NHSA |
| 海南赞邦制药有限公司 | 国药准字H20080325 | 0.2g | Category B (乙) | XR05CBY116A001010105838 | NHSA |
| 杭州沐源生物医药科技股份有限公司 | 国药准字H20263617 | 0.6g | Category B (乙) | XR05CBY116A001010184135 | NHSA |
| 广东泰来润至医药科技有限公司 | 国药准字H20265302 | 0.6g | Category B (乙) | XR05CBY116A001010185196 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20263935 | 0.6g | Category B (乙) | XR05CBY116A001010200177 | NHSA |
| 海南赛立克药业有限公司 | 国药准字H20265743 | 0.6g | Category B (乙) | XR05CBY116A001010205805 | NHSA |
| 海南赞邦制药有限公司 | 国药准字H20080325 | 0.2g | Category B (乙) | XR05CBY116A001010205838 | NHSA |
| 广东泰来润至医药科技有限公司 | 国药准字H20265302 | 0.6g | Category B (乙) | XR05CBY116A001010285196 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20263935 | 0.6g | Category B (乙) | XR05CBY116A001010300177 | NHSA |
| 海南赛立克药业有限公司 | 国药准字H20265743 | 0.6g | Category B (乙) | XR05CBY116A001010305805 | NHSA |
| 广东泰来润至医药科技有限公司 | 国药准字H20265302 | 0.6g | Category B (乙) | XR05CBY116A001010385196 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20263935 | 0.6g | Category B (乙) | XR05CBY116A001010400177 | NHSA |
| 广东泰来润至医药科技有限公司 | 国药准字H20265302 | 0.6g | Category B (乙) | XR05CBY116A001010485196 | NHSA |
| 广东泰来润至医药科技有限公司 | 国药准字H20265302 | 0.6g | Category B (乙) | XR05CBY116A001010585196 | NHSA |
| 广东泰来润至医药科技有限公司 | 国药准字H20265302 | 0.6g | Category B (乙) | XR05CBY116A001010685196 | NHSA |
| 海南赞邦制药有限公司 | 国药准字H20080326 | 0.6g | Category B (乙) | XR05CBY116A001020105838 | NHSA |
| 海南赞邦制药有限公司 | 国药准字H20080326 | 0.6g | Category B (乙) | XR05CBY116A001020205838 | NHSA |
| 海南赞邦制药有限公司 | 国药准字H20080326 | 0.6g | Category B (乙) | XR05CBY116A001020305838 | NHSA |
| 海南赞邦制药有限公司 | 国药准字H20080326 | 0.6g | Category B (乙) | XR05CBY116A001020405838 | 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: 8 filings and 8 distinct first applicants.
Generic 8
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江西迪赛诺医药集团有限公司 | CYHS2602506 | Generic | 2026/10/13 | Not stated by source | CDE |
| 广东赛康制药厂有限公司 | CYHS2602434 | Generic | 2026/09/30 | Not stated by source | CDE |
| 华益药业科技（安徽）有限公司 | CYHS2601524 | Generic | 2026/06/29 | Not stated by source | CDE |
| 浙江金华康恩贝生物制药有限公司 | CYHS2601460 | Generic | 2026/06/22 | Not stated by source | CDE |
| 长春澜江医药科技有限公司;植恩生物技术股份有限公司 | CYHS2600860 | Generic | 2026/04/15 | Not stated by source | CDE |
| 河北瑞森药业有限公司 | CYHS2600621 | Generic | 2026/03/06 | Not stated by source | CDE |
| 浙江皓格药业有限公司;成都通德药业有限公司 | CYHS2504115 | Generic | 2025/11/29 | Not stated by source | CDE |
| 重庆圣华曦药业股份有限公司 | CYHS2503754 | Generic | 2025/10/22 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 8 filings and 6 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江西迪赛诺医药集团有限公司 | CYHS2602506 | Generic | 2026/10/13 | Not stated by source | CDE |
| 广东赛康制药厂有限公司 | CYHS2602434 | Generic | 2026/09/30 | Not stated by source | CDE |
| 广东赛康制药厂有限公司 | CYHS2601581 | Generic | 2026/07/03 | Not stated by source | CDE |
| 华益药业科技（安徽）有限公司 | CYHS2601524 | Generic | 2026/06/29 | Not stated by source | CDE |
| 浙江金华康恩贝生物制药有限公司 | CYHS2601460 | Generic | 2026/06/22 | Not stated by source | CDE |
| 长春澜江医药科技有限公司;植恩生物技术股份有限公司 | CYHS2600860 | Generic | 2026/04/15 | Not stated by source | CDE |
| 河北瑞森药业有限公司 | CYHS2600621 | Generic | 2026/03/06 | Not stated by source | CDE |
| 长春澜江医药科技有限公司;植恩生物技术股份有限公司 | CYHS2600151 | Generic | 2026/01/13 | Not stated by source | CDE |
API registrations
Non-component matches: 12 companies with A status and 5 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 |
|---|---|---|---|---|---|---|
| 乙酰半胱氨酸 | 浙江海昌药业股份有限公司 | Y20260000718 | I | Exact ingredient | 2026/08/14 | CDE |
| 乙酰半胱氨酸 | PharmaZell GmbH | Y20250001320 | I | Exact ingredient | 2026/04/28 | CDE |
| 乙酰半胱氨酸 | 浙江海洲制药股份有限公司 | Y20260000217 | I | Exact ingredient | 2026/03/27 | CDE |
| 乙酰半胱氨酸 | 津药药业股份有限公司 | Y20240001520 | I | Exact ingredient | 2025/05/28 | CDE |
| 乙酰半胱氨酸 | 湖南九典宏阳制药有限公司 | Y20240001419 | A | Exact ingredient | 2026/09/10 | CDE |
| 乙酰半胱氨酸 | 浙江金华康恩贝生物制药有限公司 | Y20240001287 | A | Exact ingredient | 2026/06/02 | CDE |
| 乙酰半胱氨酸 | 湖南华纳大药厂手性药物有限公司 | Y20230001045 | A | Exact ingredient | 2025/05/20 | CDE |
| 乙酰半胱氨酸 | 浙江诚意药业股份有限公司 | Y20220000261 | A | Exact ingredient | 2024/05/22 | CDE |
| 乙酰半胱氨酸 | 七星化学制药股份有限公司 | Y20220000066 | A | Exact ingredient | 2024/01/25 | CDE |
| 乙酰半胱氨酸 | 山西阳和药业有限公司 | Y20210001235 | A | Exact ingredient | 2025/02/06 | CDE |
| 乙酰半胱氨酸 | 福建南方制药股份有限公司 | Y20210001183 | A | Exact ingredient | 2024/09/17 | CDE |
| 乙酰半胱氨酸 | 浙江赛默制药有限公司 | Y20210001203 | A | Exact ingredient | 2025/10/18 | CDE |
| 乙酰半胱氨酸 | Nippon Rika Co., Ltd. | Y20200000078 | A | Exact ingredient | 2023/03/24 | CDE |
| 乙酰半胱氨酸 | 武汉远大弘元股份有限公司 | Y20190009549 | A | Exact ingredient | 2025/09/24 | CDE |
| 乙酰半胱氨酸 | F.I.S. Fabbrica Italiana Sintetici S.P.A. | Y20190009052 | A | Exact ingredient | 2024/05/22 | CDE |
| 乙酰半胱氨酸 | 浙江诚意药业股份有限公司 | Y20190007528 | A | Exact ingredient | 2024/05/22 | CDE |
| 乙酰半胱氨酸 | 湖北新生源生物工程有限公司 | Y20190006101 | A | Exact ingredient | 2026/01/29 | CDE |
| 乙酰半胱氨酸 | MOEHS IBERICA S.L. | Y20170000715 | I | Exact ingredient | — | 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.
-
2026/11/03Marketing application approved
广州仁恒医药科技股份有限公司
CYHS2501401 · 国药准字H20266430
Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06
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 50 ↗ -
2026/10/13Accepted
-
2026/09/30Accepted
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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