Monthly
US$200
Billed every month
Companies, stages and changes, with each record available on this page.
Last 90 days: No longer listed under review: 2 applicationsSupplement delivery: 2 applications
Current coverage may be incomplete
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.
Loaded records: 4 holders; 1 in the quality-and-efficacy consistency-evaluation category, and 3 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 |
|---|---|---|---|---|---|---|
| 广东粤和泽药物研究有限公司 | 广东星昊药业有限公司 | 国药准字H20265708 | 2026/08/25 | 按红霉素计0.5g(50万单位) | 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 |
| 海南广升誉制药有限公司 | 海南灵康制药有限公司 | 国药准字H20265577 | 2026/08/04 | 按红霉素计0.25g(25万单位) | 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 |
| 海南广升誉制药有限公司 | 海南灵康制药有限公司 | 国药准字H20265578 | 2026/08/04 | 按红霉素计0.5g(50万单位) | 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 |
| 广东万泰科创药业有限公司 | 广东隆赋药业股份有限公司 | 国药准字H20263149 | 2026/01/20 | 按红霉素计0.5g(50万单位) | 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H43020028 | 2026/10/16 | 按红霉素计0.25g(25万单位) | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | 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H20269253 | 2026/10/16 | 按红霉素计0.5g(50万单位) | 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.
Loaded records: 30 distinct approval numbers and 18 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 上海上药新亚药业有限公司 | 国药准字H31021503 | 按红霉素计0.25g(25万单位) | Category A (甲) | XJ01FAH016B001010100792 | NHSA |
| 美罗药业股份有限公司 | 国药准字H21021678 | 按红霉素计0.25g(25万单位) | Category A (甲) | XJ01FAH016B001010101122 | NHSA |
| 武汉久安药业有限公司 | 国药准字H42020871 | 0.25g(25万单位) | Category A (甲) | XJ01FAH016B001010101949 | NHSA |
| 成都第一制药有限公司 | 国药准字H51023236 | 按红霉素计0.25g(25万单位) | Category A (甲) | XJ01FAH016B001010102080 | NHSA |
| 西安利君制药有限责任公司 | 国药准字H61022363 | 按红霉素计0.25g(25万单位) | Category A (甲) | XJ01FAH016B001010102503 | NHSA |
| 湖北美林药业有限公司 | 国药准字H14020379 | 0.3g(30万单位) | Category A (甲) | XJ01FAH016B001010102946 | NHSA |
| 山西双雁药业有限公司 | 国药准字H14020729 | 0.25g(25万单位) | Category A (甲) | XJ01FAH016B001010102954 | NHSA |
| 哈药集团制药总厂 | 国药准字H23021442 | 按红霉素计0.3g(30万单位) | Category A (甲) | XJ01FAH016B001010103712 | NHSA |
| 湖南科伦制药有限公司 | 国药准字H43020028 | 按红霉素计0.25g(25万单位) | Category A (甲) | XJ01FAH016B001010105006 | NHSA |
| 广西梧州制药(集团)股份有限公司 | 国药准字H45021339 | 0.25g(25万单位) | Category A (甲) | XJ01FAH016B001010105156 | NHSA |
| 江西赣南海欣药业股份有限公司 | 国药准字H36021156 | 按红霉素计0.25g(25万单位) | Category A (甲) | XJ01FAH016B001010105283 | NHSA |
| 海南广升誉制药有限公司 | 国药准字H20265578 | 按红霉素计0.5g(50万单位) | Category A (甲) | XJ01FAH016B001010181251 | NHSA |
| 广东金城金素制药有限公司 | 国药准字H20263854 | 按红霉素计0.25g(25万单位) | Category A (甲) | XJ01FAH016B001010181979 | NHSA |
| 广东万泰元科创药业有限公司 | 国药准字H20263149 | 按红霉素计0.5g(50万单位) | Category A (甲) | XJ01FAH016B001010185190 | NHSA |
| 武汉久安药业有限公司 | 国药准字H42020871 | 0.25g(25万单位) | Category A (甲) | XJ01FAH016B001010201949 | NHSA |
| 西安利君制药有限责任公司 | 国药准字H61022363 | 按红霉素计0.25g(25万单位) | Category A (甲) | XJ01FAH016B001010202503 | NHSA |
| 湖北美林药业有限公司 | 国药准字H14020379 | 0.3g(30万单位) | Category A (甲) | XJ01FAH016B001010202946 | NHSA |
| 国药集团国瑞药业有限公司 | 国药准字H34023638 | 0.25g(25万单位) | Category A (甲) | XJ01FAH016B001010204383 | NHSA |
| 江西赣南海欣药业股份有限公司 | 国药准字H36021156 | 按红霉素计0.25g(25万单位) | Category A (甲) | XJ01FAH016B001010205283 | NHSA |
| 海南广升誉制药有限公司 | 国药准字H20265578 | 按红霉素计0.5g(50万单位) | Category A (甲) | XJ01FAH016B001010281251 | NHSA |
| 广东万泰元科创药业有限公司 | 国药准字H20263149 | 按红霉素计0.5g(50万单位) | Category A (甲) | XJ01FAH016B001010285190 | NHSA |
| 西安利君制药有限责任公司 | 国药准字H61022363 | 按红霉素计0.25g(25万单位) | Category A (甲) | XJ01FAH016B001010302503 | NHSA |
| 美罗药业股份有限公司 | 国药准字H21021679 | 按红霉素计0.30g(30万单位) | Category A (甲) | XJ01FAH016B001020101122 | NHSA |
| 武汉久安药业有限公司 | 国药准字H42020872 | 0.3g(30万单位) | Category A (甲) | XJ01FAH016B001020101949 | NHSA |
| 西安利君制药有限责任公司 | 国药准字H61022364 | 按红霉素计0.3g(30万单位) | Category A (甲) | XJ01FAH016B001020102503 | NHSA |
| 山西双雁药业有限公司 | 国药准字H14022626 | 按红霉素计0.3g(30万单位) | Category A (甲) | XJ01FAH016B001020102954 | NHSA |
| 国药集团国瑞药业有限公司 | 国药准字H34023637 | 0.3g(30万单位) | Category A (甲) | XJ01FAH016B001020104383 | NHSA |
| 湖南科伦制药有限公司 | 国药准字H43020027 | 按红霉素计0.3g(30万单位) | Category A (甲) | XJ01FAH016B001020105006 | NHSA |
| 广西梧州制药(集团)股份有限公司 | 国药准字H45021338 | 0.3g(30万单位) | Category A (甲) | XJ01FAH016B001020105156 | NHSA |
| 江西赣南海欣药业股份有限公司 | 国药准字H36021155 | 按红霉素计0.3g(30万单位) | Category A (甲) | XJ01FAH016B001020105283 | NHSA |
| 海南广升誉制药有限公司 | 国药准字H20265577 | 按红霉素计0.25g(25万单位) | Category A (甲) | XJ01FAH016B001020181251 | NHSA |
| 广东金城金素制药有限公司 | 国药准字H20263855 | 按红霉素计0.5g(50万单位) | Category A (甲) | XJ01FAH016B001020181979 | NHSA |
| 武汉久安药业有限公司 | 国药准字H42020872 | 0.3g(30万单位) | Category A (甲) | XJ01FAH016B001020201949 | NHSA |
| 湖南科伦制药有限公司 | 国药准字H43020027 | 按红霉素计0.3g(30万单位) | Category A (甲) | XJ01FAH016B001020205006 | NHSA |
| 海南广升誉制药有限公司 | 国药准字H20265577 | 按红霉素计0.25g(25万单位) | Category A (甲) | XJ01FAH016B001020281251 | NHSA |
| 美罗药业股份有限公司 | 国药准字H21021678 | 按红霉素计0.25g(25万单位) | Category A (甲) | XJ01FAH016B001030101122 | NHSA |
| 西安利君制药有限责任公司 | 国药准字H61022364 | 按红霉素计0.3g(30万单位) | Category A (甲) | XJ01FAH016B001030102503 | NHSA |
| 国药集团国瑞药业有限公司 | 国药准字H34023638 | 0.25g(25万单位) | Category A (甲) | XJ01FAH016B001030104383 | NHSA |
| 湖南科伦制药有限公司 | 国药准字H43020028 | 按红霉素计0.25g(25万单位) | Category A (甲) | XJ01FAH016B001030105006 | NHSA |
| 江西赣南海欣药业股份有限公司 | 国药准字H36021155 | 按红霉素计0.3g(30万单位) | Category A (甲) | XJ01FAH016B001030105283 | NHSA |
| 西安利君制药有限责任公司 | 国药准字H61022364 | 按红霉素计0.3g(30万单位) | Category A (甲) | XJ01FAH016B001030202503 | NHSA |
| 美罗药业股份有限公司 | 国药准字H21021679 | 按红霉素计0.30g(30万单位) | Category A (甲) | XJ01FAH016B001040101122 | NHSA |
| 西安利君制药有限责任公司 | 国药准字H61022364 | 按红霉素计0.3g(30万单位) | Category A (甲) | XJ01FAH016B001040102503 | NHSA |
| 西安利君制药有限责任公司 | 国药准字H61022363 | 按红霉素计0.25g(25万单位) | Category A (甲) | XJ01FAH016B001050102503 | NHSA |
| 成都第一制药有限公司 | 国药准字H51023235 | 按红霉素计0.3g(30万单位) | Category A (甲) | XJ01FAH016B003010102080 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20053846 | 按红霉素计0.25g(25万单位) | Category A (甲) | XJ01FAH016B013010104152 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20053846 | 按红霉素计0.25g(25万单位) | Category A (甲) | XJ01FAH016B013010204152 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20053847 | 按红霉素计0.3g(30万单位) | Category A (甲) | XJ01FAH016B013020104152 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20053847 | 按红霉素计0.3g(30万单位) | Category A (甲) | XJ01FAH016B013020204152 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20053846 | 按红霉素计0.25g(25万单位) | Category A (甲) | XJ01FAH016B013030104152 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20053847 | 按红霉素计0.3g(30万单位) | Category A (甲) | XJ01FAH016B013040104152 | NHSA |
| 西安迪赛生物药业有限责任公司 | 国药准字H61021775 | 按红霉素计0.3g(30万单位) | Category A (甲) | XJ01FAH016B014010102470 | NHSA |
| 广东粤和泽药物研究有限公司 | 国药准字H20265708 | 按红霉素计0.5g(50万单位) | Category A (甲) | XJ01FAH016B001010184887 | 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.
Loaded records: 13 filings and 8 distinct first applicants.
Generic 11 · Supplement 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 苏州二叶制药有限公司 | CYHS2504472 | Generic | 2025/12/30 | Not stated by source | CDE |
| 苏州二叶制药有限公司 | CYHS2504471 | Generic | 2025/12/30 | Not stated by source | CDE |
| 广东大翔制药有限公司;海南通用三洋药业有限公司 | CYHS2601857 | Generic | 2026/08/03 | 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 | CYHS2502490 | Generic | 2025/07/12 | 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 | CYHS2502489 | Generic | 2025/07/12 | Not stated by source | CDE |
| 海韬新药研发(江苏)有限公司;津药和平(天津)制药有限公司 | CYHS2500734 | Generic | 2025/02/13 | Not stated by source | CDE |
| 江西赣南海欣药业股份有限公司 | CYHB2650137 | Supplement | 2026/06/16 | Not stated by source | CDE |
| 江西赣南海欣药业股份有限公司 | CYHB2650136 | Supplement | 2026/06/16 | Not stated by source | CDE |
| 哈尔滨三联药业股份有限公司 | CYHS2600795 | Generic | 2026/04/08 | Not stated by source | CDE |
| 哈尔滨三联药业股份有限公司 | CYHS2600794 | Generic | 2026/04/08 | Not stated by source | CDE |
| 福安药业集团湖北人民制药有限公司 | CYHS2503278 | Generic | 2025/09/05 | Not stated by source | CDE |
| 福安药业集团湖北人民制药有限公司 | CYHS2503277 | Generic | 2025/09/05 | Not stated by source | CDE |
| 海南允鼎医药科技有限公司;海口奇力制药股份有限公司 | CYHS2502675 | Generic | 2025/07/24 | Not stated by source | CDE |
Loaded records: 3 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 广东大翔制药有限公司;海南通用三洋药业有限公司 | CYHS2601857 | Generic | 2026/08/03 | Not stated by source | CDE |
| 哈尔滨三联药业股份有限公司 | CYHS2600795 | Generic | 2026/04/08 | Not stated by source | CDE |
| 哈尔滨三联药业股份有限公司 | CYHS2600794 | Generic | 2026/04/08 | Not stated by source | CDE |
Non-component matches: 4 companies with A status and 4 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 |
|---|---|---|---|---|---|---|
| 乳糖酸红霉素 | 成都百裕制药股份有限公司 | Y20260000044 | I | Exact ingredient | 2026/01/30 | CDE |
| 乳糖酸红霉素 | 江西赣南海欣药业股份有限公司 | Y20250001359 | I | Exact ingredient | 2025/12/25 | CDE |
| 乳糖酸红霉素 | 浙江华纳药业有限公司 | Y20250000445 | I | Exact ingredient | 2025/06/06 | CDE |
| 乳糖酸红霉素 | 广东态森德制药有限公司 | Y20240001069 | I | Exact ingredient | 2024/12/02 | CDE |
| 乳糖酸红霉素 | 北京金城泰尔制药有限公司 | Y20230001264 | A | Exact ingredient | 2025/10/23 | CDE |
| 乳糖酸红霉素 | 西安利君制药有限责任公司 | Y20190005670 | A | Exact ingredient | 2026/01/07 | CDE |
| 乳糖酸红霉素 | 黄石黄抗药业有限公司 | Y20190004886 | A | Exact ingredient | — | CDE |
| 乳糖酸红霉素 | 美罗药业股份有限公司 | Y20190004202 | A | Exact ingredient | 2025/01/16 | 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.
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.
CYHS2404422
Fact date: 2026/11/07 · Site observation date: 2026/11/07
Accepted: 2024/12/20
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHS2404313
Fact date: 2026/11/07 · Site observation date: 2026/11/07
Accepted: 2024/12/12
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHB2550288 · 国药准字H20269253
Fact date: 2026/10/16 · Publication date: 2026/10/21 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 3 ↗CYHB2550287
Fact date: 2026/10/16 · Publication date: 2026/10/21 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 2 ↗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.
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.
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.
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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