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Vitamin K1 Injection(维生素K1注射液)
Companies, stages and changes, with each record available on this page.
Last 90 days: No 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.
Company names, approval identifiers and strengths are retained as recorded in the Chinese sources. Category labels include the original wording for verification.
Catalogue holders4View records ↓
Under-review filings6View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers22View records ↓
API companies with A status17View records ↓
Chemical-drug catalogue
Loaded records: 4 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 4 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 |
|---|---|---|---|---|---|---|
| 成都苑东生物制药股份有限公司 | 成都苑东生物制药股份有限公司 | 国药准字H20266188 | 2026/09/29 | 0.2ml:2mg | 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 |
| 海南美康达药业有限公司 | 安徽长江药业有限公司 | 国药准字H20265728 | 2026/08/25 | 1ml:10mg | 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 |
| 成都苑东生物制药股份有限公司 | 成都苑东生物制药股份有限公司 | 国药准字H20264352 | 2026/05/19 | 1ml:10mg | 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 |
| 合肥亿帆生物制药有限公司 | 合肥亿帆生物制药有限公司 | 国药准字H20263243 | 2026/01/27 | 1ml:10mg | 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 |
| 合肥亿帆生物制药有限公司 | 合肥亿帆生物制药有限公司 | 国药准字H20256509 | 2025/12/30 | 0.2ml:2mg | 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 |
| 海南倍特药业有限公司 | 海南倍特药业有限公司 | 国药准字H20253984 | 2025/04/22 | 1ml∶10mg | 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 |
| 海南倍特药业有限公司 | 海南倍特药业有限公司 | 国药准字H20253983 | 2025/04/22 | 0.2ml∶2mg | 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: 22 distinct approval numbers and 19 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 江苏华阳制药有限公司 | 国药准字H32020820 | 1ml:10mg | Category A (甲) | XB02BAW055B002010101447 | NHSA |
| 正大天晴药业集团股份有限公司 | 国药准字H32026409 | 1ml:10mg | Category A (甲) | XB02BAW055B002010101523 | NHSA |
| 江苏悦兴药业有限公司 | 国药准字H32020161 | 1ml:10mg | Category A (甲) | XB02BAW055B002010101631 | NHSA |
| 成都倍特药业股份有限公司 | 国药准字H32021752 | 1ml:10mg | Category A (甲) | XB02BAW055B002010101708 | NHSA |
| 成都苑东生物制药股份有限公司 | 国药准字H20264352 | 1ml:10mg | Category A (甲) | XB02BAW055B002010102181 | NHSA |
| 上海现代哈森(商丘)药业有限公司 | 国药准字H20044180 | 1ml:10mg | Category A (甲) | XB02BAW055B002010103202 | NHSA |
| 遂成药业股份有限公司 | 国药准字H41021051 | 1ml:10mg | Category A (甲) | XB02BAW055B002010103204 | NHSA |
| 国药集团容生制药有限公司 | 国药准字H20043401 | 1ml:10mg | Category A (甲) | XB02BAW055B002010103205 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H37021988 | 1ml:10mg | Category A (甲) | XB02BAW055B002010104127 | NHSA |
| 山东益康药业股份有限公司 | 国药准字H37021817 | 1ml:10mg | Category A (甲) | XB02BAW055B002010104193 | NHSA |
| 安徽长江药业有限公司 | 国药准字H34021789 | 1ml:10mg | Category A (甲) | XB02BAW055B002010104451 | NHSA |
| 浙江诚意药业股份有限公司 | 国药准字H33020864 | 1ml:10mg | Category A (甲) | XB02BAW055B002010104615 | NHSA |
| 江苏华阳制药有限公司 | 国药准字H32020820 | 1ml:10mg | Category A (甲) | XB02BAW055B002010201447 | NHSA |
| 成都倍特药业股份有限公司 | 国药准字H32021752 | 1ml:10mg | Category A (甲) | XB02BAW055B002010201708 | NHSA |
| 上海现代哈森(商丘)药业有限公司 | 国药准字H20044180 | 1ml:10mg | Category A (甲) | XB02BAW055B002010203202 | NHSA |
| 遂成药业股份有限公司 | 国药准字H41021051 | 1ml:10mg | Category A (甲) | XB02BAW055B002010203204 | NHSA |
| 国药集团容生制药有限公司 | 国药准字H20043401 | 1ml:10mg | Category A (甲) | XB02BAW055B002010203205 | NHSA |
| 山东益康药业股份有限公司 | 国药准字H37021817 | 1ml:10mg | Category A (甲) | XB02BAW055B002010204193 | NHSA |
| 上海上药第一生化药业有限公司 | 国药准字H31021967 | 1ml:10mg | Category A (甲) | XB02BAW055B002020100651 | NHSA |
| 成都苑东生物制药股份有限公司 | 国药准字H20266188 | 0.2ml:2mg | Category A (甲) | XB02BAW055B002020102181 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H37021988 | 1ml:10mg | Category A (甲) | XB02BAW055B002020104127 | NHSA |
| 安徽长江药业有限公司 | 国药准字H34021789 | 1ml:10mg | Category A (甲) | XB02BAW055B002020104451 | NHSA |
| 浙江诚意药业股份有限公司 | 国药准字H33020864 | 1ml:10mg | Category A (甲) | XB02BAW055B002020104615 | NHSA |
| 上海上药第一生化药业有限公司 | 国药准字H31021967 | 1ml:10mg | Category A (甲) | XB02BAW055B002020200651 | NHSA |
| 成都苑东生物制药股份有限公司 | 国药准字H20266188 | 0.2ml:2mg | Category A (甲) | XB02BAW055B002020202181 | NHSA |
| 石家庄四药有限公司 | 国药准字H20265620 | 1ml:10mg | Category A (甲) | XB02BAW055B002010102763 | NHSA |
| 海南倍特药业有限公司 | 国药准字H20253983 | 0.2ml:2mg | Category A (甲) | XB02BAW055B002010105791 | NHSA |
| 齐鲁制药(海南)有限公司 | 国药准字H20265579 | 1ml:10mg | Category A (甲) | XB02BAW055B002010105847 | NHSA |
| 合肥亿帆生物制药有限公司 | 国药准字H20256509 | 0.2ml:2mg | Category A (甲) | XB02BAW055B002010182719 | NHSA |
| CHEPLAPHARM Arzneimittel GmbH | 国药准字HJ20260029 | 0.2 ml:2mg | Category A (甲) | XB02BAW055B002010183365 | NHSA |
| 海南美康达药业有限公司 | 国药准字H20265728 | 1ml∶10mg | Category A (甲) | XB02BAW055B002010183920 | NHSA |
| 海南倍特药业有限公司 | 国药准字H20253983 | 0.2ml:2mg | Category A (甲) | XB02BAW055B002010205791 | NHSA |
| CHEPLAPHARM Arzneimittel GmbH | 国药准字HJ20260029 | 0.2 ml:2mg | Category A (甲) | XB02BAW055B002010283365 | NHSA |
| 海南倍特药业有限公司 | 国药准字H20253983 | 0.2ml:2mg | Category A (甲) | XB02BAW055B002010305791 | NHSA |
| 海南倍特药业有限公司 | 国药准字H20253984 | 1ml:10mg | Category A (甲) | XB02BAW055B002020105791 | NHSA |
| 合肥亿帆生物制药有限公司 | 国药准字H20263243 | 1ml:10mg | Category A (甲) | XB02BAW055B002020182719 | NHSA |
| 海南倍特药业有限公司 | 国药准字H20253984 | 1ml:10mg | Category A (甲) | XB02BAW055B002020205791 | NHSA |
| 海南美康达药业有限公司 | 国药准字H20265728 | 1ml∶10mg | Category A (甲) | XB02BAW055B002010283920 | 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: 6 filings and 6 distinct first applicants.
Generic 4 · Supplement 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏九旭药业有限公司 | CYHS2503464 | Generic | 2025/09/19 | Not stated by source | CDE |
| 重庆莱美药业股份有限公司;南京臣功制药股份有限公司 | CYHS2601084 | Generic | 2026/05/12 | Not stated by source | CDE |
| 江苏安必生制药有限公司 | CYHS2502437 | Generic | 2025/07/09 | Not stated by source | CDE |
| 浙江诚意药业股份有限公司 | CYHB2650146 | Supplement | 2026/06/29 | Not stated by source | CDE |
| 深圳欣祺医药科技有限公司;广东星昊药业有限公司 | CYHS2601413 | Generic | 2026/06/15 | Not stated by source | CDE |
| 辰欣药业股份有限公司 | CYHB2650068 | Supplement | 2026/02/28 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 17 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 |
|---|---|---|---|---|---|---|
| 维生素K1 | 山东新时代药业有限公司 | Y20260000279 | I | Exact ingredient | 2026/04/30 | CDE |
| 维生素K1 | DSM-FIRMENICH SWITZERLAND AG | Y20250000811 | I | Exact ingredient | 2025/12/03 | CDE |
| 维生素K1 | 卡文迪许（泰州）药业有限公司 | Y20240000837 | A | Exact ingredient | 2026/06/01 | CDE |
| 维生素K1 | 山东辰龙药业有限公司 | Y20240000719 | A | Exact ingredient | 2026/05/20 | CDE |
| 维生素K1 | 美药星（南京）制药有限公司 | Y20240000482 | I | Exact ingredient | 2026/01/29 | CDE |
| 维生素K1 | 汉瑞药业（荆门）有限公司 | Y20230001326 | A | Exact ingredient | 2025/09/30 | CDE |
| 维生素K1 | 重庆瑞泊莱制药有限公司 | Y20230001196 | A | Exact ingredient | 2026/09/16 | CDE |
| 维生素K1 | 安徽威尔曼制药有限公司 | Y20230000958 | A | Exact ingredient | 2025/04/30 | CDE |
| 维生素K1 | 内蒙古白医制药股份有限公司 | Y20230000341 | A | Exact ingredient | 2024/10/25 | CDE |
| 维生素K1 | 浙江诚意药业股份有限公司 | Y20190004531 | A | Exact ingredient | 2025/07/28 | CDE |
| 维生素K1 | 上海现代哈森（商丘）药业有限公司 | Y20220001273 | A | Exact ingredient | 2025/07/15 | CDE |
| 维生素K1 | Sionc Pharmaceuticals Pvt Ltd. | Y20210000355 | A | Exact ingredient | 2026/06/02 | CDE |
| 维生素K1 | SANYO FINE CO., LTD. | Y20210000304 | A | Exact ingredient | 2025/01/13 | CDE |
| 维生素K1 | 海思科制药（眉山）有限公司 | Y20210000014 | A | Exact ingredient | 2022/09/20 | CDE |
| 维生素K1 | ENALTEC LABS PVT LTD | Y20200000930 | I | Exact ingredient | 2020/09/10 | CDE |
| 维生素K1 | 江苏慈星药业有限公司 | Y20190021611 | A | Exact ingredient | 2025/05/18 | CDE |
| 维生素K1 | 安徽万和制药有限公司 | Y20190008808 | A | Exact ingredient | 2026/02/10 | CDE |
| 维生素K1 | 四川仁安药业有限责任公司 | Y20190005900 | A | Exact ingredient | 2025/07/15 | CDE |
| 维生素K1 | 山东广通宝医药有限公司 | Y20190002014 | A | Exact ingredient | 2025/01/21 | CDE |
| 维生素K1 | 国营张家港市制药厂 | Y20190001251 | A | Exact ingredient | — | CDE |
| 维生素K1 | 海南卫康制药（潜山）有限公司 | Y20170001286 | I | Exact ingredient | — | CDE |
| 维生素K1 | 上海紫源制药有限公司 | Y20170000510 | A | Exact ingredient | 2026/01/15 | 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.
-
2026/11/04No longer listed under review
海南全盈药业有限公司;扬州中宝药业股份有限公司
CYHS2501407
Fact date: 2026/11/04 · Site observation date: 2026/11/04
Accepted: 2025/04/11
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
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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