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Cetrorelix Acetate for Injection(注射用醋酸西曲瑞克)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 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 holders18View records ↓
Under-review filings4View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers16View records ↓
API companies with A status12View records ↓
Chemical-drug catalogue
Loaded records: 18 holders; 1 in the quality-and-efficacy consistency-evaluation category, and 16 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 |
|---|---|---|---|---|---|---|
| 山西威奇达光明制药有限公司 | 山西威奇达光明制药有限公司 | 国药准字H20265901 | 2026/09/08 | 0.25mg（按C70H92ClN17O14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 |
| 山东新时代药业有限公司 | 山东新时代药业有限公司 | 国药准字H20265746 | 2026/08/25 | 0.25mg（按C70H92ClN17O14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 |
| 苏州天马医药集团天吉生物制药有限公司 | 苏州天马医药集团天吉生物制药有限公司 | 国药准字H20265766 | 2026/08/25 | 0.25mg（按C70H92ClN17O14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 |
| 常州四药制药有限公司 | 常州四药制药有限公司 | 国药准字H20264945 | 2026/06/23 | 0.25mg（按C70H92ClN17O14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 |
| 南京海辰药业股份有限公司 | 南京海辰药业股份有限公司 | 国药准字H20264796 | 2026/06/17 | 0.25mg（按C70H92ClN17O14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 |
| 武汉人福利康药业有限公司 | 福建基诺厚普生物科技有限公司 | 国药准字H20263806 | 2026/03/31 | 0.25mg（按C70H92ClN17O14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 |
| 南京海融制药有限公司 | 江苏利泰尔药业有限公司 | 国药准字H20263289 | 2026/02/02 | 0.25mg（按C70H92ClN17O14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 |
| 扬子江药业集团广州海瑞药业有限公司 | 扬子江药业集团广州海瑞药业有限公司 | 国药准字H20255711 | 2025/10/14 | 0.25mg（按C70H92ClN17O14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 |
| 江苏诺泰澳赛诺生物制药股份有限公司 | 江苏诺泰澳赛诺生物制药股份有限公司 | 国药准字H20254895 | 2025/07/22 | 0.25mg（按C70H92ClN17O14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 |
| 南京康舟医药科技有限公司 | 常州千红生化制药股份有限公司 | 国药准字H20254056 | 2025/04/30 | 0.25mg（按C70H92ClN17O14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 |
| 开封明仁药业有限公司 | 开封明仁药业有限公司 | 国药准字H20244760 | 2024/08/27 | 0.25mg（以C70H92ClN17O14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 |
| 齐鲁制药有限公司 | 齐鲁制药有限公司 | 国药准字H20243480 | 2024/04/11 | 0.25mg（按C70H92ClN17O14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 |
| 海南中和药业股份有限公司 | 海南中和药业股份有限公司 | 国药准字H20234144 | 2023/09/12 | 0.25mg（按C70H92ClN17O14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 |
| 辉凌制药（中国）有限公司 | 深圳翰宇药业股份有限公司 | 国药准字H20183468 | 2023/07/10 | 0.25mg（按C70H92ClN17O14计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 海南天盛保和生物科技有限公司 | 海南皇隆制药股份有限公司 | 国药准字H20233630 | 2023/05/29 | 0.25mg（以西曲瑞克计） | 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 |
| 长春金赛药业有限责任公司 | 长春金赛药业有限责任公司 | 国药准字H20223913 | 2022/11/30 | 0.25mg（以西曲瑞克计） | 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 |
| 丽珠集团丽珠制药厂 | 南京健友生化制药股份有限公司 | 国药准字H20213977 | 2021/12/31 | 0.25mg（以西曲瑞克计） | 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 |
| Merck Europe B.V. | Pierre Fabre Medicament Production, Aquitaine Pharm International | H20140476 | 2005/02/21 | 0.25mg（以西曲瑞克计） | Imported originator drug (进口原研药品) | 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: 16 distinct approval numbers and 16 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 扬子江药业集团广州海瑞药业有限公司 | 国药准字H20255711 | 0.25mg(按C₇₀H₉₂ClN₁₇O₁₄计) | Not stated by source | XH01CCX013B001010100568 | NHSA |
| 常州四药制药有限公司 | 国药准字H20264945 | 0.25mg(按C₇₀H₉₂ClN₁₇O₁₄ 计) | Not stated by source | XH01CCX013B001010101389 | NHSA |
| 南京海辰药业股份有限公司 | 国药准字H20264796 | 0.25mg(按C₇₀H₉₂ClN₁₇O₁₄计) | Not stated by source | XH01CCX013B001010101563 | NHSA |
| 山西威奇达光明制药有限公司 | 国药准字H20265901 | 0.25mg(按C₇₀H₉₂ClN₁₇O₁₄计) | Not stated by source | XH01CCX013B001010102841 | NHSA |
| 长春金赛药业有限责任公司 | 国药准字H20223913 | 0.25mg(以西曲瑞克计) | Not stated by source | XH01CCX013B001010103315 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20243480 | 0.25mg(按C₇₀H₉₂ClN₁₇O₁₄计) | Not stated by source | XH01CCX013B001010104021 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20265746 | 0.25mg(按C₇₀H₉₂ClN₁₇O₁₄计) | Not stated by source | XH01CCX013B001010104188 | NHSA |
| 海南中和药业股份有限公司 | 国药准字H20234144 | 0.25mg(按C₇₀H₉₂ClN₁₇O₁₄计) | Not stated by source | XH01CCX013B001010105842 | NHSA |
| 开封明仁药业有限公司 | 国药准字H20244760 | 0.25mg(以C₇₀H₉₂ClN₁₇O₁₄ 计) | Not stated by source | XH01CCX013B001010107462 | NHSA |
| Merck (Schweiz) AG | 国药准字HJ20140476 | 0.25mg(按C₇₀H₉₂ClN₁₇O₁₄计) | Not stated by source | XH01CCX013B001010178860 | NHSA |
| 辉凌制药(中国)有限公司 | 国药准字H20183468 | 0.25mg(按C₇₀H₉₂ClN₁₇O₁₄计) | Not stated by source | XH01CCX013B001010179260 | NHSA |
| 江苏诺泰澳赛诺生物制药股份有限公司 | 国药准字H20254895 | 0.25mg(按C₇₀H₉₂ClN₁₇O₁₄计) | Not stated by source | XH01CCX013B001010180539 | NHSA |
| 武汉人福利康药业有限公司 | 国药准字H20263806 | 0.25mg(按C₇₀H₉₂ClN₁₇O₁₄计) | Not stated by source | XH01CCX013B001010181917 | NHSA |
| 海南天盛保和生物科技有限公司 | 国药准字H20233630 | 0.25mg(以西曲瑞克计) | Not stated by source | XH01CCX013B001010183116 | NHSA |
| 南京康舟医药科技有限公司 | 国药准字H20254056 | 0.25mg(按C₇₀H₉₂ClN₁₇O₁₄计) | Not stated by source | XH01CCX013B001010183233 | NHSA |
| 丽珠集团丽珠制药厂 | 国药准字H20213977 | 0.25mg(以西曲瑞克计) | Not stated by source | XH01CCX013B001010201570 | NHSA |
| 海南中和药业股份有限公司 | 国药准字H20234144 | 0.25mg(按C₇₀H₉₂ClN₁₇O₁₄计) | Not stated by source | XH01CCX013B001010205842 | NHSA |
| Merck (Schweiz) AG | 国药准字HJ20140476 | 0.25mg(按C₇₀H₉₂ClN₁₇O₁₄计) | Not stated by source | XH01CCX013B001010278860 | NHSA |
| 辉凌制药(中国)有限公司 | 国药准字H20183468 | 0.25mg(按C₇₀H₉₂ClN₁₇O₁₄计) | Not stated by source | XH01CCX013B001010279260 | NHSA |
| 海南天盛保和生物科技有限公司 | 国药准字H20233630 | 0.25mg(以西曲瑞克计) | Not stated by source | XH01CCX013B001010283116 | NHSA |
| 丽珠集团丽珠制药厂 | 国药准字H20213977 | 0.25mg(以西曲瑞克计) | Not stated by source | XH01CCX013B001010301570 | NHSA |
| 辉凌制药(中国)有限公司 | 国药准字H20183468 | 0.25mg(按C₇₀H₉₂ClN₁₇O₁₄计) | Not stated by source | XH01CCX013B001010379260 | NHSA |
| 丽珠集团丽珠制药厂 | 国药准字H20213977 | 0.25mg(以西曲瑞克计) | Not stated by source | XH01CCX013B001010401570 | NHSA |
| 丽珠集团丽珠制药厂 | 国药准字H20213977 | 0.25mg(以西曲瑞克计) | Not stated by source | XH01CCX013B001010501570 | NHSA |
| 丽珠集团丽珠制药厂 | 国药准字H20213977 | 0.25mg(以西曲瑞克计) | Not stated by source | XH01CCX013B001010601570 | 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 4 distinct first applicants.
Generic 4
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 安徽安科生物工程（集团）股份有限公司 | CYHS2602026 | Generic | 2026/08/17 | Not stated by source | CDE |
| 北京双鹭药业股份有限公司 | CYHS2504311 | Generic | 2025/12/18 | Not stated by source | CDE |
| 浙江众延医药科技有限公司;双鹤药业（海南）有限责任公司 | CYHS2500614 | Generic | 2025/02/07 | Not stated by source | CDE |
| 南京海纳制药有限公司 | CYHS2602620 | Generic | 2026/10/26 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 12 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 |
|---|---|---|---|---|---|---|
| 醋酸西曲瑞克 | 扬子江药业集团江苏海慈生物药业有限公司 | Y20260000749 | I | Exact ingredient | 2026/08/27 | CDE |
| 醋酸西曲瑞克 | BCN PEPTIDES, SA | Y20240001059 | I | Exact ingredient | 2025/01/15 | CDE |
| 醋酸西曲瑞克 | 山西同达药业有限公司 | Y20240000543 | A | Exact ingredient | 2026/01/28 | CDE |
| 醋酸西曲瑞克 | 南京海融制药有限公司 | Y20230001331 | A | Exact ingredient | 2025/08/22 | CDE |
| 醋酸西曲瑞克 | 苏州天马医药集团天吉生物制药有限公司 | Y20230000378 | A | Exact ingredient | 2024/12/07 | CDE |
| 醋酸西曲瑞克 | 开封明仁药业有限公司 | Y20220000773 | A | Exact ingredient | 2024/08/20 | CDE |
| 醋酸西曲瑞克 | 江苏诺泰澳赛诺生物制药股份有限公司 | Y20220000567 | A | Exact ingredient | 2024/06/06 | CDE |
| 醋酸西曲瑞克 | 上海苏豪逸明制药有限公司 | Y20220000449 | A | Exact ingredient | 2024/10/26 | CDE |
| 醋酸西曲瑞克 | 成都圣诺生物制药有限公司 | Y20220000342 | A | Exact ingredient | 2024/02/23 | CDE |
| 醋酸西曲瑞克 | 翰宇药业（武汉）有限公司 | Y20220000234 | A | Exact ingredient | 2026/10/14 | CDE |
| 醋酸西曲瑞克 | 海南中和药业股份有限公司 | Y20210001264 | A | Exact ingredient | 2024/06/06 | CDE |
| 醋酸西曲瑞克 | 哈尔滨吉象隆生物技术有限公司 | Y20210000112 | A | Exact ingredient | 2024/01/17 | CDE |
| 醋酸西曲瑞克 | 中肽生化有限公司 | Y20190001147 | A | Exact ingredient | 2026/07/03 | CDE |
| 醋酸西曲瑞克 | 开封明仁药业有限公司 | Y20170000653 | I | Exact ingredient | — | CDE |
| 醋酸西曲瑞克 | 深圳翰宇药业股份有限公司 | Y20170000279 | A | Exact ingredient | 2022/09/27 | 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.
-
2026/10/26Accepted
-
2026/08/17Accepted
安徽安科生物工程（集团）股份有限公司
CYHS2602026
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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