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 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: 10 holders; 4 in the quality-and-efficacy consistency-evaluation category, and 6 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 |
|---|---|---|---|---|---|---|
| 江苏瑜兴医药科技有限公司 | 马鞍山丰原制药有限公司 | 国药准字H20265863 | 2026/09/02 | 0.1g(按C21H30O5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 |
| 成都米子生物医药科技有限公司 | 四川汇宇制药股份有限公司 | 国药准字H20264656 | 2026/06/10 | 100mg(按C21H30O5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 |
| 海南紫程众投生物科技有限公司 | 辽宁海思科制药有限公司 | 国药准字H20264410 | 2026/05/19 | 0.1g(按C21H30O5?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H20093293 | 2026/05/11 | 50mg(按C21H30O5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 |
| 江苏江丰医药科技有限公司 | 津药和平(天津)制药有限公司 | 国药准字H20263039 | 2026/01/05 | 0.1g(按C21H30O5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 |
| 烟台东诚北方制药有限公司 | 烟台东诚北方制药有限公司 | 国药准字H20084319 | 2025/04/29 | 50mg(按C21H30O5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 |
| 烟台东诚北方制药有限公司 | 烟台东诚北方制药有限公司 | 国药准字H20084318 | 2025/04/29 | 0.1g(按C21H30O5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 |
| 津药和平(天津)制药有限公司 | 津药和平(天津)制药有限公司 | 国药准字H20253862 | 2025/04/15 | 按C21H30O5计 50mg | 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 |
| 津药和平(天津)制药有限公司 | 津药和平(天津)制药有限公司 | 国药准字H20253863 | 2025/04/15 | 按C21H30O5计 100mg | 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 |
| 福安药业集团湖北人民制药有限公司 | 福安药业集团湖北人民制药有限公司 | 国药准字H20058653 | 2024/08/01 | 50mg(按C21H30O5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 |
| 天津力生制药股份有限公司 | 天津生物化学制药有限公司 | 国药准字H12020493 | 2024/03/28 | 50mg(按C21H30O5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 |
| 天津力生制药股份有限公司 | 天津生物化学制药有限公司 | 国药准字H12020486 | 2024/03/28 | 0.1g(按C21H30O5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 |
| 福安药业集团湖北人民制药有限公司 | 福安药业集团湖北人民制药有限公司 | 国药准字H20058654 | 2024/01/22 | 0.1g(按C21H30O5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 |
| 沐源(安徽)药业有限公司 | 海南合瑞制药股份有限公司 | 国药准字H20266277 | 2026/10/13 | 按C21H30O5计 100mg | 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 |
| 沐源(安徽)药业有限公司 | 海南合瑞制药股份有限公司 | 国药准字H20266276 | 2026/10/13 | 按C21H30O5计 50mg | 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 |
| 成都米子生物医药科技有限公司 | 四川汇宇制药股份有限公司 | 国药准字H20264655 | 2026/06/10 | 50mg(按C21H30O5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 |
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: 18 distinct approval numbers and 11 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 天津力生制药股份有限公司 | 国药准字H12020486 | 0.1g(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001010100918 | NHSA |
| 津药和平(天津)制药有限公司 | 国药准字H20253862 | 按C₂₁H₃₀O₅计 50mg | Category A (甲) | XH02ABQ060B001010100952 | NHSA |
| 常州四药制药有限公司 | 国药准字H20093293 | 0.05g | Category A (甲) | XH02ABQ060B001010101389 | NHSA |
| 福安药业集团湖北人民制药有限公司 | 国药准字H20058654 | 0.1g(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001010101877 | NHSA |
| 烟台东诚北方制药有限公司 | 国药准字H20084318 | 100mg(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001010104233 | NHSA |
| 江苏江丰医药科技有限公司 | 国药准字H20263039 | 0.1g(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001010183817 | NHSA |
| 海南紫程众投生物科技有限公司 | 国药准字H20264410 | 0.1g(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001010184112 | NHSA |
| 江苏瑜兴医药科技有限公司 | 国药准字H20265863 | 0.1g(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001010184659 | NHSA |
| 重庆万霖生物医药科技有限公司 | 国药准字H20265756 | 50mg(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001010184896 | NHSA |
| 成都米子生物医药科技有限公司 | 国药准字H20264655 | 50mg(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001010185135 | NHSA |
| 常州四药制药有限公司 | 国药准字H20093293 | 0.05g | Category A (甲) | XH02ABQ060B001010201389 | NHSA |
| 烟台东诚北方制药有限公司 | 国药准字H20084318 | 100mg(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001010204233 | NHSA |
| 江苏江丰医药科技有限公司 | 国药准字H20263039 | 0.1g(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001010283817 | NHSA |
| 江苏瑜兴医药科技有限公司 | 国药准字H20265863 | 0.1g(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001010284659 | NHSA |
| 天津力生制药股份有限公司 | 国药准字H12020493 | 50mg(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001020100918 | NHSA |
| 津药和平(天津)制药有限公司 | 国药准字H20253863 | 按C₂₁H₃₀O₅计 100mg | Category A (甲) | XH02ABQ060B001020100952 | NHSA |
| 福安药业集团湖北人民制药有限公司 | 国药准字H20058653 | 50mg(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001020101877 | NHSA |
| 烟台东诚北方制药有限公司 | 国药准字H20084319 | 50mg(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001020104233 | NHSA |
| 重庆万霖生物医药科技有限公司 | 国药准字H20265757 | 100mg(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001020184896 | NHSA |
| 成都米子生物医药科技有限公司 | 国药准字H20264656 | 100mg(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001020185135 | NHSA |
| 福安药业集团湖北人民制药有限公司 | 国药准字H20058653 | 50mg(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001020201877 | NHSA |
| 烟台东诚北方制药有限公司 | 国药准字H20084319 | 50mg(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001020204233 | NHSA |
| 天津力生制药股份有限公司 | 国药准字H12020486 | 0.1g(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001030100918 | NHSA |
| 福安药业集团湖北人民制药有限公司 | 国药准字H20058654 | 0.1g(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001030101877 | NHSA |
| 天津力生制药股份有限公司 | 国药准字H12020493 | 50mg(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001030200918 | NHSA |
| 福安药业集团湖北人民制药有限公司 | 国药准字H20058653 | 50mg(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001040101877 | NHSA |
| 福安药业集团湖北人民制药有限公司 | 国药准字H20058654 | 0.1g(按C₂₁H₃₀O₅计) | Category A (甲) | XH02ABQ060B001050101877 | NHSA |
| 沐源(安徽)药业有限公司 | 国药准字H20266276 | 按C₂₁H₃₀O₅计 50mg | Category A (甲) | XH02ABQ060B001010185656 | NHSA |
| 沐源(安徽)药业有限公司 | 国药准字H20266276 | 按C₂₁H₃₀O₅计 50mg | Category A (甲) | XH02ABQ060B001010285656 | NHSA |
| 沐源(安徽)药业有限公司 | 国药准字H20266277 | 按C₂₁H₃₀O₅计 100mg | Category A (甲) | XH02ABQ060B001020185656 | NHSA |
| 沐源(安徽)药业有限公司 | 国药准字H20266277 | 按C₂₁H₃₀O₅计 100mg | Category A (甲) | XH02ABQ060B001020285656 | 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: 16 filings and 10 distinct first applicants.
Generic 16
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京泽恒医药技术开发有限公司;马鞍山丰原制药有限公司 | CYHS2502416 | Generic | 2025/07/08 | Not stated by source | CDE |
| 重庆市义力医药科技有限公司;马鞍山丰原制药有限公司 | CYHS2601653 | Generic | 2026/07/10 | Not stated by source | CDE |
| 重庆市义力医药科技有限公司;马鞍山丰原制药有限公司 | CYHS2601652 | Generic | 2026/07/10 | Not stated by source | CDE |
| 武汉人福药业有限责任公司;四川汇宇制药股份有限公司 | CYHS2601434 | Generic | 2026/06/17 | Not stated by source | CDE |
| 湖南醇健制药科技有限公司;国药集团容生制药有限公司 | CYHS2600644 | Generic | 2026/03/11 | Not stated by source | CDE |
| 山东达冠医药科技有限公司;烟台东诚北方制药有限公司 | CYHS2600513 | Generic | 2026/02/25 | Not stated by source | CDE |
| 海南紫程众投生物科技有限公司;辽宁海思科制药有限公司 | CYHS2503584 | Generic | 2025/09/30 | Not stated by source | CDE |
| 西藏安星医药有限公司;海南合瑞制药股份有限公司 | CYHS2503087 | Generic | 2025/08/23 | Not stated by source | CDE |
| 西藏安星医药有限公司;海南合瑞制药股份有限公司 | CYHS2503086 | Generic | 2025/08/23 | Not stated by source | CDE |
| 湖南醇健制药科技有限公司;国药集团容生制药有限公司 | CYHS2502300 | Generic | 2025/06/27 | Not stated by source | CDE |
| 江西人可医药科技有限公司;沈阳光大制药有限公司 | CYHS2502100 | Generic | 2025/06/12 | Not stated by source | CDE |
| 江西人可医药科技有限公司;沈阳光大制药有限公司 | CYHS2502099 | Generic | 2025/06/12 | Not stated by source | CDE |
| 河南利华制药有限公司;成都天台山制药股份有限公司 | CYHS2501100 | Generic | 2025/03/18 | Not stated by source | CDE |
| 河南利华制药有限公司;成都天台山制药股份有限公司 | CYHS2501099 | Generic | 2025/03/18 | Not stated by source | CDE |
| 重庆士立德医药科技有限公司;福安药业集团湖北人民制药有限公司 | CYHS2402621 | Generic | 2024/08/13 | Not stated by source | CDE |
| 重庆士立德医药科技有限公司;福安药业集团湖北人民制药有限公司 | CYHS2402620 | Generic | 2024/08/13 | Not stated by source | CDE |
Loaded records: 5 filings and 4 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 重庆市义力医药科技有限公司;马鞍山丰原制药有限公司 | CYHS2601653 | Generic | 2026/07/10 | Not stated by source | CDE |
| 重庆市义力医药科技有限公司;马鞍山丰原制药有限公司 | CYHS2601652 | Generic | 2026/07/10 | Not stated by source | CDE |
| 武汉人福药业有限责任公司;四川汇宇制药股份有限公司 | CYHS2601434 | Generic | 2026/06/17 | Not stated by source | CDE |
| 湖南醇健制药科技有限公司;国药集团容生制药有限公司 | CYHS2600644 | Generic | 2026/03/11 | Not stated by source | CDE |
| 山东达冠医药科技有限公司;烟台东诚北方制药有限公司 | CYHS2600513 | Generic | 2026/02/25 | Not stated by source | CDE |
Non-component matches: 6 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 |
|---|---|---|---|---|---|---|
| 氢化可的松琥珀酸钠 | ARIHANTANAM LIFE CARE PVT. LTD. | Y20250001230 | I | Exact ingredient | 2025/12/18 | CDE |
| 氢化可的松琥珀酸钠 | 四川仁安药业有限责任公司 | Y20250001095 | I | Exact ingredient | 2025/10/17 | CDE |
| 氢化可的松琥珀酸钠 | 天津信谊津津药业有限公司 | Y20250000227 | A | Exact ingredient | 2026/09/04 | CDE |
| 氢化可的松琥珀酸钠 | 山东锐顺药业有限公司 | Y20250000198 | A | Exact ingredient | 2026/09/08 | CDE |
| 氢化可的松琥珀酸钠 | 常州四药制药有限公司 | Y20240001012 | A | Exact ingredient | 2026/03/02 | CDE |
| 氢化可的松琥珀酸钠 | NEWCHEM S.P.A. | Y20240000180 | I | Exact ingredient | 2024/07/09 | CDE |
| 氢化可的松琥珀酸钠 | 津药药业股份有限公司 | Y20220000589 | A | Exact ingredient | 2024/09/30 | CDE |
| 氢化可的松琥珀酸钠 | 河南利华制药有限公司 | Y20190009439 | A | Exact ingredient | 2026/07/09 | CDE |
| 氢化可的松琥珀酸钠 | 天津生物化学制药有限公司 | Y20190007427 | A | Exact ingredient | 2024/08/15 | CDE |
| 氢化可的松琥珀酸钠 | 河南利华制药有限公司 | Y20190000287 | I | Exact ingredient | 2019/05/17 | 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.
CYHS2403585
Fact date: 2026/11/05 · Site observation date: 2026/11/05
Accepted: 2024/10/24
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHS2403584
Fact date: 2026/11/05 · Site observation date: 2026/11/05
Accepted: 2024/10/24
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗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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