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注射用阿立哌唑
Companies, stages and changes, with each record available on this page.
No changes recorded by this site in the last 90 days
Complete CDE snapshot: 2026/11/10 07:27
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 holders1View records ↓
Under-review filings4View records ↓
This year’s generic filers3View records ↓
NHSA approval numbers4View records ↓
API companies with A status25View records ↓
Chemical-drug catalogue
Loaded records: 1 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 1 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 |
|---|---|---|---|---|---|---|
| 湖南科伦制药有限公司 | 湖南科伦制药有限公司 | 国药准字H20263611 | 2026/03/17 | 0.3g（按C23H27Cl2N3O2计） | 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 |
| 湖南科伦制药有限公司 | 湖南科伦制药有限公司 | 国药准字H20263610 | 2026/03/17 | 0.4g（按C23H27Cl2N3O2计） | 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: 4 distinct approval numbers and 2 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 湖南科伦制药有限公司 | 国药准字H20263611 | 0.3g(按C₂₃H₂₇Cl₂N₃O₂计) | Category B (乙) | XN05AXA028B001010104948 | NHSA |
| Otsuka Pharmaceutical Co.,Ltd. | 国药准字HJ20230055 | 0.4g(按C₂₃H₂₇Cl₂N₃O₂计) | Category B (乙) | XN05AXA028B001010179080 | NHSA |
| 湖南科伦制药有限公司 | 国药准字H20263610 | 0.4g(按C₂₃H₂₇Cl₂N₃O₂计) | Category B (乙) | XN05AXA028B001020104948 | NHSA |
| Otsuka Pharmaceutical Co.,Ltd. | 国药准字HJ20230054 | 0.3g(按C₂₃H₂₇Cl₂N₃O₂计) | Category B (乙) | XN05AXA028B001020179080 | 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: 4 filings and 3 distinct first applicants.
Generic 4
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 丽珠集团丽珠制药厂;健康元海滨药业有限公司 | CYHS2601903 | Generic | 2026/08/05 | Not stated by source | CDE |
| 齐鲁制药有限公司 | CYHS2600627 | Generic | 2026/03/16 | Not stated by source | CDE |
| 齐鲁制药有限公司 | CYHS2600626 | Generic | 2026/03/16 | Not stated by source | CDE |
| 辰欣药业股份有限公司;广州玻思韬控释药业有限公司 | CYHS2600408 | Generic | 2026/02/07 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 4 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 丽珠集团丽珠制药厂;健康元海滨药业有限公司 | CYHS2601903 | Generic | 2026/08/05 | Not stated by source | CDE |
| 齐鲁制药有限公司 | CYHS2600627 | Generic | 2026/03/16 | Not stated by source | CDE |
| 齐鲁制药有限公司 | CYHS2600626 | Generic | 2026/03/16 | Not stated by source | CDE |
| 辰欣药业股份有限公司;广州玻思韬控释药业有限公司 | CYHS2600408 | Generic | 2026/02/07 | Not stated by source | CDE |
API registrations
Non-component matches: 25 companies with A status and 9 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 |
|---|---|---|---|---|---|---|
| 阿立哌唑 | 山东辰龙药业有限公司 | Y20250000844 | I | Exact ingredient | 2025/08/28 | CDE |
| 阿立哌唑 | 珠海保税区丽珠合成制药有限公司 | Y20250000187 | I | Exact ingredient | 2025/08/05 | CDE |
| 阿立哌唑 | 山东辰龙药业有限公司 | Y20250000530 | I | Exact ingredient | 2025/06/03 | CDE |
| 阿立哌唑 | 齐鲁制药有限公司 | Y20240001040 | I | Exact ingredient | 2026/01/06 | CDE |
| 阿立哌唑 | 山东辰龙药业有限公司 | Y20230000758 | I | Exact ingredient | 2024/06/12 | CDE |
| 阿立哌唑 | 珠海保税区丽珠合成制药有限公司 | Y20230000505 | A | Exact ingredient | 2025/09/15 | CDE |
| 阿立哌唑 | 四川新开元制药有限公司 | Y20230000470 | A | Exact ingredient | 2026/06/16 | CDE |
| 阿立哌唑 | 河北凯威康领制药有限公司 | Y20230000232 | A | Exact ingredient | 2024/12/11 | CDE |
| 阿立哌唑 | Cadila Pharmaceuticals Limited. | Y20220001214 | I | Exact ingredient | 2023/03/08 | CDE |
| 阿立哌唑 | 岳阳新华达制药有限公司 | Y20220000015 | A | Exact ingredient | 2023/11/01 | CDE |
| 阿立哌唑 | 重庆凯林制药有限公司 | Y20210000572 | A | Exact ingredient | 2024/10/24 | CDE |
| 阿立哌唑 | 瑞阳制药股份有限公司 | Y20210001131 | A | Exact ingredient | 2024/05/30 | CDE |
| 阿立哌唑 | 兰西哈三联制药有限公司 | Y20210000981 | A | Exact ingredient | 2024/01/17 | CDE |
| 阿立哌唑 | COHANCE LIFESCIENCES LIMITED | Y20210000511 | A | Exact ingredient | 2025/02/10 | CDE |
| 阿立哌唑 | 扬子江药业集团江苏海慈生物药业有限公司 | Y20200001152 | A | Exact ingredient | 2025/08/17 | CDE |
| 阿立哌唑 | Krka, d.d., Novo mesto | Y20200000433 | A | Exact ingredient | 2024/04/27 | CDE |
| 阿立哌唑 | 上海中西三维药业有限公司 | Y20190021556 | A | Exact ingredient | 2026/04/16 | CDE |
| 阿立哌唑 | MSN Pharmachem Private Limited | Y20190000736 | A | Exact ingredient | 2026/09/30 | CDE |
| 阿立哌唑 | 四川弘远药业有限公司 | Y20190007526 | A | Exact ingredient | 2026/01/17 | CDE |
| 阿立哌唑 | 江苏豪森药业集团有限公司 | Y20190007394 | A | Exact ingredient | 2023/09/01 | CDE |
| 阿立哌唑 | 江苏恩华药业股份有限公司 | Y20190001422 | A | Exact ingredient | 2024/12/28 | CDE |
| 阿立哌唑 | 重庆凯林制药有限公司 | Y20190001376 | A | Exact ingredient | 2024/08/27 | CDE |
| 阿立哌唑 | Neuland Laboratories Limited | Y20190000418 | A | Exact ingredient | 2026/01/06 | CDE |
| 阿立哌唑 | 乳源东阳光药业有限公司 | Y20190000017 | A | Exact ingredient | 2025/12/10 | CDE |
| 阿立哌唑 | 万全万特制药（厦门）有限公司 | Y20180001584 | A | Exact ingredient | 2023/07/31 | CDE |
| 阿立哌唑 | 齐鲁制药有限公司 | Y20180001051 | A | Exact ingredient | 2025/05/24 | CDE |
| 阿立哌唑 | 浙江华海药业股份有限公司 | Y20170002177 | A | Exact ingredient | 2026/05/20 | CDE |
| 阿立哌唑 | Otsuka Pharmaceutical Co., Ltd. | Y20170001495 | A | Exact ingredient | 2024/09/30 | CDE |
| 阿立哌唑 | 山东特珐曼药业有限公司 | Y20170001432 | A | Exact ingredient | 2025/03/05 | CDE |
| 阿立哌唑 | 南京正大天晴制药有限公司 | Y20170001381 | I | Exact ingredient | — | CDE |
| 阿立哌唑 | 辰欣药业股份有限公司 | Y20170001294 | I | Exact ingredient | — | CDE |
| 阿立哌唑 | 浙江海正药业股份有限公司 | Y20170001236 | A | Exact ingredient | 2023/04/27 | CDE |
| 阿立哌唑 | 重庆圣华曦药业股份有限公司 | Y20170001209 | A | Exact ingredient | 2024/08/07 | CDE |
| 阿立哌唑 | Jubilant Biosys Limited | Y20170000502 | A | Exact ingredient | 2026/10/10 | CDE |
| 阿立哌唑 | 天津红日药业股份有限公司 | Y20170000442 | 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.
- No matching records were found in the currently loaded source data; coverage dates are listed below.
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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