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Amisulpride Oral Solution(氨磺必利口服溶液)
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationSupplement delivery: 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 filings7View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers8View records ↓
API companies with A status7View 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: 8 distinct approval numbers and 8 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 广州大光制药有限公司 | 国药准字H20244722 | 60ml:6g | Category B (乙) | XN05ALA161X001010100548 | NHSA |
| 常州四药制药有限公司 | 国药准字H20256319 | 60ml : 6g | Category B (乙) | XN05ALA161X001010101389 | NHSA |
| 浙江浙北药业有限公司 | 国药准字H20265259 | 60ml:6g | Category B (乙) | XN05ALA161X001010104755 | NHSA |
| 上海信谊金朱药业有限公司 | 国药准字H20243190 | 60ml:6g | Category B (乙) | XN05ALA161X001010110323 | NHSA |
| 江苏长泰药业股份有限公司 | 国药准字H20256323 | 60ml:6g | Category B (乙) | XN05ALA161X001010181484 | NHSA |
| 广东金城金素制药有限公司 | 国药准字H20233767 | 60ml: 6g | Category B (乙) | XN05ALA161X001010181979 | NHSA |
| 仁合益康集团有限公司 | 国药准字H20255463 | 60ml:6g | Category B (乙) | XN05ALA161X001010183033 | NHSA |
| 宏越科技(湖州)有限公司 | 国药准字H20263482 | 60ml:6g | Category B (乙) | XN05ALA161X001010184219 | 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: 7 filings and 7 distinct first applicants.
Generic 7
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏贝佳制药有限公司 | CYHS2502294 | Generic | 2025/06/27 | Not stated by source | CDE |
| 四川森科制药有限公司 | CYHS2600599 | Generic | 2026/03/02 | Not stated by source | CDE |
| 武汉益博元医药科技有限公司;赤峰源生药业有限公司 | CYHS2600386 | Generic | 2026/02/06 | Not stated by source | CDE |
| 河北义海医药科技有限公司;知和(山东)大药厂有限公司 | CYHS2503000 | Generic | 2025/08/16 | Not stated by source | CDE |
| 成都康弘药业集团股份有限公司;太极集团四川太极制药有限公司 | CYHS2502767 | Generic | 2025/08/01 | Not stated by source | CDE |
| 西洲医药科技（浙江）有限公司;浙江北生药业汉生制药有限公司 | CYHS2502146 | Generic | 2025/06/17 | Not stated by source | CDE |
| 福安药业集团湖北人民制药有限公司 | CYHS2501908 | Generic | 2025/05/28 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 7 companies with A status and 3 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 |
|---|---|---|---|---|---|---|
| 氨磺必利 | 河北海盛药业有限公司 | Y20260000739 | I | Exact ingredient | 2026/08/17 | CDE |
| 氨磺必利 | 内蒙古康普药业有限公司 | Y20250001469 | I | Exact ingredient | 2026/01/05 | CDE |
| 氨磺必利 | Biochemical and Synthetic Products Private Limited | Y20230001017 | I | Exact ingredient | 2023/12/22 | CDE |
| 氨磺必利 | 浙江华海药业股份有限公司 | Y20210001005 | A | Exact ingredient | 2023/06/22 | CDE |
| 氨磺必利 | 江苏阿尔法药业股份有限公司 | Y20200001338 | A | Exact ingredient | 2022/10/14 | CDE |
| 氨磺必利 | 河北安健成益医药科技有限公司 | Y20200000200 | A | Exact ingredient | 2024/04/04 | CDE |
| 氨磺必利 | 山东安弘制药有限公司 | Y20190004491 | A | Exact ingredient | 2025/01/16 | CDE |
| 氨磺必利 | 湖北浩信药业有限公司 | Y20180000192 | A | Exact ingredient | 2025/09/24 | CDE |
| 氨磺必利 | 山东锐顺药业有限公司 | Y20170001214 | A | Exact ingredient | 2026/04/04 | CDE |
| 氨磺必利 | SYMED LABS LIMITED | Y20170000731 | A | Exact ingredient | 2024/11/29 | 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.
-
2026/10/20Supplement delivery
江苏天平药业有限公司
CYHB2600910 · 国药准字H20266307
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 34 ↗ -
2026/10/20Marketing application approved
江苏天平药业有限公司
CYHS2500712 · 国药准字H20266307
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 34 ↗
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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