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As of 13 November 2026, for Vitamin K1 Injection, 6 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 4 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Trial registration: 1 applicationNo 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.
Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.
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 |
|---|---|---|---|---|---|---|
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20266188 | 2026/09/29 | 0.2ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Mei Kang Da Pharma Co., Ltd. romanized | Anhui Chang Jiang Pharma Co., Ltd. romanized | 国药准字H20265728 | 2026/08/25 | 1ml:10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20264352 | 2026/05/19 | 1ml:10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized | Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized | 国药准字H20263243 | 2026/01/27 | 1ml:10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized | Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized | 国药准字H20256509 | 2025/12/30 | 0.2ml:2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Brilliant Pharmaceutical Co., Ltd. | Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H20253984 | 2025/04/22 | 1ml∶10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Brilliant Pharmaceutical Co., Ltd. | Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H20253983 | 2025/04/22 | 0.2ml∶2mg | Generic approved under the new chemical-drug registration classification | 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 |
|---|---|---|---|---|---|
| Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | 国药准字H32020820 | 1ml:10mg | Category A | XB02BAW055B002010101447 | NHSA |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 国药准字H32026409 | 1ml:10mg | Category A | XB02BAW055B002010101523 | NHSA |
| Jiangsu Yue Xing Pharma Co., Ltd. romanized | 国药准字H32020161 | 1ml:10mg | Category A | XB02BAW055B002010101631 | NHSA |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H32021752 | 1ml:10mg | Category A | XB02BAW055B002010101708 | NHSA |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20264352 | 1ml:10mg | Category A | XB02BAW055B002010102181 | NHSA |
| Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized | 国药准字H20044180 | 1ml:10mg | Category A | XB02BAW055B002010103202 | NHSA |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H41021051 | 1ml:10mg | Category A | XB02BAW055B002010103204 | NHSA |
| Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20043401 | 1ml:10mg | Category A | XB02BAW055B002010103205 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H37021988 | 1ml:10mg | Category A | XB02BAW055B002010104127 | NHSA |
| Shandong Yi Kang Pharma Co., Ltd. romanized | 国药准字H37021817 | 1ml:10mg | Category A | XB02BAW055B002010104193 | NHSA |
| Anhui Chang Jiang Pharma Co., Ltd. romanized | 国药准字H34021789 | 1ml:10mg | Category A | XB02BAW055B002010104451 | NHSA |
| Zhejiang Cheng Yi Pharma Co., Ltd. romanized | 国药准字H33020864 | 1ml:10mg | Category A | XB02BAW055B002010104615 | NHSA |
| Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | 国药准字H32020820 | 1ml:10mg | Category A | XB02BAW055B002010201447 | NHSA |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H32021752 | 1ml:10mg | Category A | XB02BAW055B002010201708 | NHSA |
| Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized | 国药准字H20044180 | 1ml:10mg | Category A | XB02BAW055B002010203202 | NHSA |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H41021051 | 1ml:10mg | Category A | XB02BAW055B002010203204 | NHSA |
| Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20043401 | 1ml:10mg | Category A | XB02BAW055B002010203205 | NHSA |
| Shandong Yi Kang Pharma Co., Ltd. romanized | 国药准字H37021817 | 1ml:10mg | Category A | XB02BAW055B002010204193 | NHSA |
| Shanghai Shang Yao Di Yi Sheng Hua Pharma Co., Ltd. romanized | 国药准字H31021967 | 1ml:10mg | Category A | XB02BAW055B002020100651 | NHSA |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20266188 | 0.2ml:2mg | Category A | XB02BAW055B002020102181 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H37021988 | 1ml:10mg | Category A | XB02BAW055B002020104127 | NHSA |
| Anhui Chang Jiang Pharma Co., Ltd. romanized | 国药准字H34021789 | 1ml:10mg | Category A | XB02BAW055B002020104451 | NHSA |
| Zhejiang Cheng Yi Pharma Co., Ltd. romanized | 国药准字H33020864 | 1ml:10mg | Category A | XB02BAW055B002020104615 | NHSA |
| Shanghai Shang Yao Di Yi Sheng Hua Pharma Co., Ltd. romanized | 国药准字H31021967 | 1ml:10mg | Category A | XB02BAW055B002020200651 | NHSA |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20266188 | 0.2ml:2mg | Category A | XB02BAW055B002020202181 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20265620 | 1ml:10mg | Category A | XB02BAW055B002010102763 | NHSA |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H20253983 | 0.2ml:2mg | Category A | XB02BAW055B002010105791 | NHSA |
| Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20265579 | 1ml:10mg | Category A | XB02BAW055B002010105847 | NHSA |
| Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized | 国药准字H20256509 | 0.2ml:2mg | Category A | XB02BAW055B002010182719 | NHSA |
| CHEPLAPHARM Arzneimittel GmbH | 国药准字HJ20260029 | 0.2 ml:2mg | Category A | XB02BAW055B002010183365 | NHSA |
| Hainan Mei Kang Da Pharma Co., Ltd. romanized | 国药准字H20265728 | 1ml∶10mg | Category A | XB02BAW055B002010183920 | NHSA |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H20253983 | 0.2ml:2mg | Category A | XB02BAW055B002010205791 | NHSA |
| CHEPLAPHARM Arzneimittel GmbH | 国药准字HJ20260029 | 0.2 ml:2mg | Category A | XB02BAW055B002010283365 | NHSA |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H20253983 | 0.2ml:2mg | Category A | XB02BAW055B002010305791 | NHSA |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H20253984 | 1ml:10mg | Category A | XB02BAW055B002020105791 | NHSA |
| Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized | 国药准字H20263243 | 1ml:10mg | Category A | XB02BAW055B002020182719 | NHSA |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H20253984 | 1ml:10mg | Category A | XB02BAW055B002020205791 | NHSA |
| Hainan Mei Kang Da Pharma Co., Ltd. romanized | 国药准字H20265728 | 1ml∶10mg | Category A | 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 |
|---|---|---|---|---|---|
| Jiangsu Jiu Xu Pharma Co., Ltd. romanized | CYHS2503464 | Generic | 2025/09/19 | Not stated by source | CDE |
| Chongqing Lai Mei Pharma Co., Ltd. romanized; Nanjing Chen Gong Pharmaceutical Co., Ltd. romanized | CYHS2601084 | Generic | 2026/05/12 | Not stated by source | CDE |
| Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized | CYHS2502437 | Generic | 2025/07/09 | Not stated by source | CDE |
| Zhejiang Cheng Yi Pharma Co., Ltd. romanized | CYHB2650146 | Supplement | 2026/06/29 | Not stated by source | CDE |
| Shenzhen Xin Qi Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. | CYHS2601413 | Generic | 2026/06/15 | Not stated by source | CDE |
| CISEN PHARMACEUTICAL CO., LTD. | CYHB2650068 | Supplement | 2026/02/28 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Chongqing Lai Mei Pharma Co., Ltd. romanized; Nanjing Chen Gong Pharmaceutical Co., Ltd. romanized | CYHS2601084 | Generic | 2026/05/12 | Not stated by source | CDE |
| Shenzhen Xin Qi Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. | CYHS2601413 | Generic | 2026/06/15 | Not stated by source | CDE |
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 · No verified English name | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20260000279 | I | Exact ingredient | 2026/04/30 | CDE |
| 维生素K1 · No verified English name | DSM-FIRMENICH SWITZERLAND AG | Y20250000811 | I | Exact ingredient | 2025/12/03 | CDE |
| 维生素K1 · No verified English name | Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized | Y20240000837 | A | Exact ingredient | 2026/06/01 | CDE |
| 维生素K1 · No verified English name | Shandong Chen Long Pharma Co., Ltd. romanized | Y20240000719 | A | Exact ingredient | 2026/05/20 | CDE |
| 维生素K1 · No verified English name | Mei Yao Xing (Nanjing) Pharmaceutical Co., Ltd. romanized | Y20240000482 | I | Exact ingredient | 2026/01/29 | CDE |
| 维生素K1 · No verified English name | Han Rui Pharma (Jing Men) Co., Ltd. romanized | Y20230001326 | A | Exact ingredient | 2025/09/30 | CDE |
| 维生素K1 · No verified English name | Chongqing Rui Po Lai Pharmaceutical Co., Ltd. romanized | Y20230001196 | A | Exact ingredient | 2026/09/16 | CDE |
| 维生素K1 · No verified English name | Anhui Wei Er Man Pharmaceutical Co., Ltd. romanized | Y20230000958 | A | Exact ingredient | 2025/04/30 | CDE |
| 维生素K1 · No verified English name | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized | Y20230000341 | A | Exact ingredient | 2024/10/25 | CDE |
| 维生素K1 · No verified English name | Zhejiang Cheng Yi Pharma Co., Ltd. romanized | Y20190004531 | A | Exact ingredient | 2025/07/28 | CDE |
| 维生素K1 · No verified English name | Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized | Y20220001273 | A | Exact ingredient | 2025/07/15 | CDE |
| 维生素K1 · No verified English name | Sionc Pharmaceuticals Pvt Ltd. | Y20210000355 | A | Exact ingredient | 2026/06/02 | CDE |
| 维生素K1 · No verified English name | SANYO FINE CO., LTD. | Y20210000304 | A | Exact ingredient | 2025/01/13 | CDE |
| 维生素K1 · No verified English name | Hai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized | Y20210000014 | A | Exact ingredient | 2022/09/20 | CDE |
| 维生素K1 · No verified English name | ENALTEC LABS PVT LTD | Y20200000930 | I | Exact ingredient | 2020/09/10 | CDE |
| 维生素K1 · No verified English name | Jiangsu Ci Xing Pharma Co., Ltd. romanized | Y20190021611 | A | Exact ingredient | 2025/05/18 | CDE |
| 维生素K1 · No verified English name | Anhui Wan He Pharmaceutical Co., Ltd. romanized | Y20190008808 | A | Exact ingredient | 2026/02/10 | CDE |
| 维生素K1 · No verified English name | Sichuan Ren An Pharma Co., Ltd. romanized | Y20190005900 | A | Exact ingredient | 2025/07/15 | CDE |
| 维生素K1 · No verified English name | Shandong Guang Tong Bao Pharmaceuticals Co., Ltd. romanized | Y20190002014 | A | Exact ingredient | 2025/01/21 | CDE |
| 维生素K1 · No verified English name | Guo Ying Zhang Jia Gang Shi Pharmaceutical Factory romanized | Y20190001251 | A | Exact ingredient | — | CDE |
| 维生素K1 · No verified English name | Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized | Y20170001286 | I | Exact ingredient | — | CDE |
| 维生素K1 · No verified English name | Shanghai Zi Yuan Pharmaceutical Co., Ltd. romanized | 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: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.
-
2026/11/10Trial registration
Hainan Hua Yi Pharma Co., Ltd. romanized
CTR20264270
First-publication date: 2026/11/10 · Site observation date: 2026/11/11
Read by this site on 2026/11/11 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
View source ↗ -
2026/11/04No longer listed under review
Hainan Quan Ying Pharma Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
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: 2026/11/13 06:42
- Chemical-drug catalogue
- Last successful update: 2026/11/13 06:39
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: 2026/11/13 06:41
- 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: 2026/11/12 18:32 · Current coverage may be incomplete
First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/13 08:09 · 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: 7/30; discovered pending details: 13. 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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