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Doxycycline Hyclate for Injection(注射用盐酸多西环素)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 3 applicationsNo 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 holders3View records ↓
Under-review filings11View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers8View records ↓
API companies with A status12View records ↓
Chemical-drug catalogue
Loaded records: 3 holders; 2 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 |
|---|---|---|---|---|---|---|
| 海南普利制药股份有限公司 | 海南普利制药股份有限公司 | 国药准字H20249576 | 2024/12/01 | 0.1g | 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 |
| 海南普利制药股份有限公司 | 海南普利制药股份有限公司 | 国药准字H20249577 | 2024/12/01 | 0.2g | 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 |
| 海口奇力制药股份有限公司 | 海口奇力制药股份有限公司 | 国药准字H20080630 | 2024/04/29 | 0.1g（按C22H24N2O8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 |
| 海南通用康力制药有限公司 | 海南通用康力制药有限公司 | 国药准字H20060405 | 2023/04/21 | 0.1g（按C22H24N2O8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 |
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 5 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 广东健信制药股份有限公司 | 国药准字H20051974 | 0.1g(以多西环素计) | Category B (乙) | XJ01AAD193B001010100348 | NHSA |
| 吉林省辉南长龙生化药业股份有限公司 | 国药准字H20193375 | 按C22H24N2O8计0.1g | Category B (乙) | XJ01AAD193B001010103421 | NHSA |
| 海南通用康力制药有限公司 | 国药准字H20060405 | 0.1g(按C₂₂H₂₄N₂O₈计) | Category B (乙) | XJ01AAD193B001010105754 | NHSA |
| 海南盈达润泽药业有限公司 | 国药准字H20080630 | 0.1g(按C₂₂H₂₄N₂O₈计) | Category B (乙) | XJ01AAD193B001010105755 | NHSA |
| 海南普利制药股份有限公司 | 国药准字H20249576 | 按C₂₂H₂₄N₂O₈计0.1g | Category B (乙) | XJ01AAD193B001010105801 | NHSA |
| 广东健信制药股份有限公司 | 国药准字H20051974 | 0.1g(以多西环素计) | Category B (乙) | XJ01AAD193B001010200348 | NHSA |
| 吉林省辉南长龙生化药业股份有限公司 | 国药准字H20193376 | 按C22H24N2O8计0.2g | Category B (乙) | XJ01AAD193B001010203421 | NHSA |
| 海南通用康力制药有限公司 | 国药准字H20060405 | 0.1g(按C₂₂H₂₄N₂O₈计) | Category B (乙) | XJ01AAD193B001010205754 | NHSA |
| 海南普利制药股份有限公司 | 国药准字H20249576 | 按C₂₂H₂₄N₂O₈计0.1g | Category B (乙) | XJ01AAD193B001010205801 | NHSA |
| 吉林省辉南长龙生化药业股份有限公司 | 国药准字H20193375 | 按C22H24N2O8计0.1g | Category B (乙) | XJ01AAD193B001010303421 | NHSA |
| 吉林省辉南长龙生化药业股份有限公司 | 国药准字H20193376 | 按C22H24N2O8计0.2g | Category B (乙) | XJ01AAD193B001010403421 | NHSA |
| 吉林省辉南长龙生化药业股份有限公司 | 国药准字H20193375 | 按C22H24N2O8计0.1g | Category B (乙) | XJ01AAD193B001010503421 | NHSA |
| 吉林省辉南长龙生化药业股份有限公司 | 国药准字H20193376 | 按C22H24N2O8计0.2g | Category B (乙) | XJ01AAD193B001010603421 | NHSA |
| 海南盈达润泽药业有限公司 | 国药准字H20080631 | 0.2g(按C₂₂H₂₄N₂O₈计) | Category B (乙) | XJ01AAD193B001020105755 | NHSA |
| 海南普利制药股份有限公司 | 国药准字H20249577 | 按C₂₂H₂₄N₂O₈计0.2g | Category B (乙) | XJ01AAD193B001020105801 | NHSA |
| 海南普利制药股份有限公司 | 国药准字H20249577 | 按C₂₂H₂₄N₂O₈计0.2g | Category B (乙) | XJ01AAD193B001020205801 | 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: 11 filings and 8 distinct first applicants.
Generic 8 · Supplement 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏联环药业股份有限公司;湖州亚瑟制药有限公司 | CYHS2502839 | Generic | 2025/08/06 | Not stated by source | CDE |
| 南京易亨制药有限公司 | CYHS2602083 | Generic | 2026/08/21 | Not stated by source | CDE |
| 苏州朗科生物技术股份有限公司;江苏海岸药业有限公司 | CYHS2501777 | Generic | 2025/05/16 | Not stated by source | CDE |
| 广东万泰元科创药业有限公司;广东隆赋药业股份有限公司 | CYHB2601761 | Supplement | 2026/09/18 | Not stated by source | CDE |
| 广东万泰元科创药业有限公司;广东隆赋药业股份有限公司 | CYHB2601760 | Supplement | 2026/09/18 | Not stated by source | CDE |
| 广东健信制药股份有限公司 | CYHB2650083 | Supplement | 2026/03/23 | Not stated by source | CDE |
| 海南卫康制药（潜山）有限公司 | CYHS2600321 | Generic | 2026/01/31 | Not stated by source | CDE |
| 海南卫康制药（潜山）有限公司 | CYHS2600319 | Generic | 2026/01/31 | Not stated by source | CDE |
| 湖北美林药业有限公司 | CYHS2503467 | Generic | 2025/09/19 | Not stated by source | CDE |
| 广东金城金素制药有限公司;广东隆赋药业股份有限公司 | CYHS2502665 | Generic | 2025/07/23 | Not stated by source | CDE |
| 广东金城金素制药有限公司;广东隆赋药业股份有限公司 | CYHS2502663 | Generic | 2025/07/23 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 3 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京易亨制药有限公司 | CYHS2602083 | Generic | 2026/08/21 | Not stated by source | CDE |
| 海南卫康制药（潜山）有限公司 | CYHS2600321 | Generic | 2026/01/31 | Not stated by source | CDE |
| 海南卫康制药（潜山）有限公司 | CYHS2600319 | Generic | 2026/01/31 | Not stated by source | CDE |
API registrations
Non-component matches: 12 companies with A status and 1 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 |
|---|---|---|---|---|---|---|
| 盐酸多西环素 | 南通常佑药业科技有限公司 | Y20240001089 | A | Exact ingredient | 2026/08/15 | CDE |
| 多西环素 | 南通常佑药业科技有限公司 | Y20240000584 | I | Salt-normalized ingredient | 2024/08/21 | CDE |
| 盐酸多西环素 | HOVIONE PHARMASCIENCE LIMITED | Y20220000451 | A | Exact ingredient | 2026/05/20 | CDE |
| 盐酸多西环素 | 上海青平药业有限公司 | Y20190006582 | A | Exact ingredient | 2026/01/31 | CDE |
| 盐酸多西环素 | 昆山东方药业有限公司 | Y20190006560 | A | Exact ingredient | — | CDE |
| 盐酸多西环素 | 石家庄华曙善合药业有限公司 | Y20190006021 | A | Exact ingredient | — | CDE |
| 盐酸多西环素 | 河北东风药业有限公司 | Y20190005098 | A | Exact ingredient | 2025/02/09 | CDE |
| 盐酸多西环素 | 苏州第五制药厂有限公司 | Y20190005068 | A | Exact ingredient | — | CDE |
| 盐酸多西环素 | 盐城苏海制药有限公司 | Y20190004892 | A | Exact ingredient | 2025/07/18 | CDE |
| 盐酸多西环素 | 常州制药厂有限公司 | Y20190004505 | A | Exact ingredient | 2025/07/09 | CDE |
| 盐酸多西环素 | 江苏联环药业股份有限公司 | Y20190004072 | A | Exact ingredient | 2025/07/30 | CDE |
| 盐酸多西环素 | 开封制药（集团）有限公司 | Y20190002589 | A | Exact ingredient | 2024/09/11 | CDE |
| 盐酸多西环素 | 山东鲁抗医药股份有限公司 | Y20190002114 | A | Exact ingredient | 2025/01/23 | 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.
-
2026/11/06No longer listed under review
海南倍特药业有限公司
CYHS2501092
Fact date: 2026/11/06 · Site observation date: 2026/11/06
Accepted: 2025/03/18
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/09/18Accepted
广东万泰元科创药业有限公司;广东隆赋药业股份有限公司
CYHB2601761
Fact date: 2026/09/18 · Site observation date: 2026/10/22
View source ↗ -
2026/09/18Accepted
广东万泰元科创药业有限公司;广东隆赋药业股份有限公司
CYHB2601760
Fact date: 2026/09/18 · Site observation date: 2026/10/22
View source ↗ -
2026/08/21Accepted
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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