Monthly
US$200
Billed every month
Companies, stages and changes, with each record available on this page.
No changes recorded by this site in the last 90 days
Complete CDE snapshot: 2026/11/10 07:27
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: 1 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 0 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 |
|---|---|---|---|---|---|---|
| AstraZeneca Pty Ltd | AstraZeneca Pty Ltd | H20140474 | 1998/02/10 | 2ml:0.5mg | Imported originator drug (进口原研药品) | CDE |
| AstraZeneca Pty Ltd | AstraZeneca Pty Ltd | H20140475 | 1998/02/10 | 2ml:1mg | Imported originator drug (进口原研药品) | 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: 19 distinct approval numbers and 15 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 健康元药业集团股份有限公司 | 国药准字H20203343 | 2ml:0.5mg | Category B (乙) | XR03BAB165L023010100545 | NHSA |
| 正大天晴药业集团股份有限公司 | 国药准字H20203063 | 2ml:1mg | Category B (乙) | XR03BAB165L023010101523 | NHSA |
| 鲁南贝特制药有限公司 | 国药准字H20256093 | 2ml:1mg | Category B (乙) | XR03BAB165L023010104010 | NHSA |
| 河北创健药业有限公司 | 国药准字H20244894 | 2ml:1mg | Category B (乙) | XR03BAB165L023010110364 | NHSA |
| AstraZeneca Pty Ltd | 国药准字HJ20140474 | 2ml:0.5mg | Category B (乙) | XR03BAB165L023010178239 | NHSA |
| 长风药业股份有限公司 | 国药准字H20213357 | 2ml:1mg | Category B (乙) | XR03BAB165L023010181450 | NHSA |
| 四川普锐特药业有限公司 | 国药准字H20213286 | 2ml:1mg | Category B (乙) | XR03BAB165L023010181590 | NHSA |
| 浙江福瑞喜药业有限公司 | 国药准字H20244983 | 2ml:1mg | Category B (乙) | XR03BAB165L023010182539 | NHSA |
| 立生医药(苏州)有限公司 | 国药准字H20255501 | 2ml:1mg | Category B (乙) | XR03BAB165L023010182772 | NHSA |
| 江苏西普拉制药有限公司 | 国药准字H20254563 | 2ml:1mg | Category B (乙) | XR03BAB165L023010183770 | NHSA |
| 艾特美(苏州)医药科技有限公司 | 国药准字H20255679 | 2ml:1mg | Category B (乙) | XR03BAB165L023010183907 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20264203 | 2ml∶1mg | Category B (乙) | XR03BAB165L023010184043 | NHSA |
| 南京力成药业有限公司 | 国药准字H20244102 | 2ml:1mg | Category B (乙) | XR03BAB165L023010184446 | NHSA |
| 湖南醇健制药科技有限公司 | 国药准字H20256149 | 2ml:1mg | Category B (乙) | XR03BAB165L023010184672 | NHSA |
| 健康元药业集团股份有限公司 | 国药准字H20203343 | 2ml:0.5mg | Category B (乙) | XR03BAB165L023010200545 | NHSA |
| 正大天晴药业集团股份有限公司 | 国药准字H20203063 | 2ml:1mg | Category B (乙) | XR03BAB165L023010201523 | NHSA |
| 鲁南贝特制药有限公司 | 国药准字H20256093 | 2ml:1mg | Category B (乙) | XR03BAB165L023010204010 | NHSA |
| 河北创健药业有限公司 | 国药准字H20244894 | 2ml:1mg | Category B (乙) | XR03BAB165L023010210364 | NHSA |
| AstraZeneca Pty Ltd | 国药准字HJ20140474 | 2ml:0.5mg | Category B (乙) | XR03BAB165L023010278239 | NHSA |
| 长风药业股份有限公司 | 国药准字H20213357 | 2ml:1mg | Category B (乙) | XR03BAB165L023010281450 | NHSA |
| 四川普锐特药业有限公司 | 国药准字H20213286 | 2ml:1mg | Category B (乙) | XR03BAB165L023010281590 | NHSA |
| 立生医药(苏州)有限公司 | 国药准字H20255501 | 2ml:1mg | Category B (乙) | XR03BAB165L023010282772 | NHSA |
| 艾特美(苏州)医药科技有限公司 | 国药准字H20255679 | 2ml:1mg | Category B (乙) | XR03BAB165L023010283907 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20264203 | 2ml∶1mg | Category B (乙) | XR03BAB165L023010284043 | NHSA |
| 南京力成药业有限公司 | 国药准字H20244102 | 2ml:1mg | Category B (乙) | XR03BAB165L023010284446 | NHSA |
| 湖南醇健制药科技有限公司 | 国药准字H20256149 | 2ml:1mg | Category B (乙) | XR03BAB165L023010284672 | NHSA |
| 健康元药业集团股份有限公司 | 国药准字H20203343 | 2ml:0.5mg | Category B (乙) | XR03BAB165L023010300545 | NHSA |
| 正大天晴药业集团股份有限公司 | 国药准字H20203063 | 2ml:1mg | Category B (乙) | XR03BAB165L023010301523 | NHSA |
| 鲁南贝特制药有限公司 | 国药准字H20256093 | 2ml:1mg | Category B (乙) | XR03BAB165L023010304010 | NHSA |
| 河北创健药业有限公司 | 国药准字H20244894 | 2ml:1mg | Category B (乙) | XR03BAB165L023010310364 | NHSA |
| AstraZeneca Pty Ltd | 国药准字HJ20140474 | 2ml:0.5mg | Category B (乙) | XR03BAB165L023010378239 | NHSA |
| 长风药业股份有限公司 | 国药准字H20213357 | 2ml:1mg | Category B (乙) | XR03BAB165L023010381450 | NHSA |
| 四川普锐特药业有限公司 | 国药准字H20213286 | 2ml:1mg | Category B (乙) | XR03BAB165L023010381590 | NHSA |
| 立生医药(苏州)有限公司 | 国药准字H20255501 | 2ml:1mg | Category B (乙) | XR03BAB165L023010382772 | NHSA |
| 艾特美(苏州)医药科技有限公司 | 国药准字H20255679 | 2ml:1mg | Category B (乙) | XR03BAB165L023010383907 | NHSA |
| 南京力成药业有限公司 | 国药准字H20244102 | 2ml:1mg | Category B (乙) | XR03BAB165L023010384446 | NHSA |
| 湖南醇健制药科技有限公司 | 国药准字H20256149 | 2ml:1mg | Category B (乙) | XR03BAB165L023010384672 | NHSA |
| 健康元药业集团股份有限公司 | 国药准字H20203343 | 2ml:0.5mg | Category B (乙) | XR03BAB165L023010400545 | NHSA |
| 正大天晴药业集团股份有限公司 | 国药准字H20203063 | 2ml:1mg | Category B (乙) | XR03BAB165L023010401523 | NHSA |
| 鲁南贝特制药有限公司 | 国药准字H20256093 | 2ml:1mg | Category B (乙) | XR03BAB165L023010404010 | NHSA |
| 河北创健药业有限公司 | 国药准字H20244894 | 2ml:1mg | Category B (乙) | XR03BAB165L023010410364 | NHSA |
| 长风药业股份有限公司 | 国药准字H20213357 | 2ml:1mg | Category B (乙) | XR03BAB165L023010481450 | NHSA |
| 立生医药(苏州)有限公司 | 国药准字H20255501 | 2ml:1mg | Category B (乙) | XR03BAB165L023010482772 | NHSA |
| 湖南醇健制药科技有限公司 | 国药准字H20256149 | 2ml:1mg | Category B (乙) | XR03BAB165L023010484672 | NHSA |
| 河北创健药业有限公司 | 国药准字H20244894 | 2ml:1mg | Category B (乙) | XR03BAB165L023010510364 | NHSA |
| 长风药业股份有限公司 | 国药准字H20213357 | 2ml:1mg | Category B (乙) | XR03BAB165L023010581450 | NHSA |
| 湖南醇健制药科技有限公司 | 国药准字H20256149 | 2ml:1mg | Category B (乙) | XR03BAB165L023010584672 | NHSA |
| 河北创健药业有限公司 | 国药准字H20244894 | 2ml:1mg | Category B (乙) | XR03BAB165L023010610364 | NHSA |
| 河北创健药业有限公司 | 国药准字H20244894 | 2ml:1mg | Category B (乙) | XR03BAB165L023010710364 | NHSA |
| 河北创健药业有限公司 | 国药准字H20244894 | 2ml:1mg | Category B (乙) | XR03BAB165L023010810364 | NHSA |
| 健康元药业集团股份有限公司 | 国药准字H20203649 | 2ml:1mg | Category B (乙) | XR03BAB165L023020100545 | NHSA |
| 正大天晴药业集团股份有限公司 | 国药准字H20247246 | 2ml:0.5mg | Category B (乙) | XR03BAB165L023020101523 | NHSA |
| AstraZeneca Pty Ltd | 国药准字HJ20140475 | 2ml:1mg | Category B (乙) | XR03BAB165L023020178239 | NHSA |
| 南京力成药业有限公司 | 国药准字H20258239 | 2ml:0.5mg | Category B (乙) | XR03BAB165L023020184446 | NHSA |
| 健康元药业集团股份有限公司 | 国药准字H20203649 | 2ml:1mg | Category B (乙) | XR03BAB165L023020200545 | NHSA |
| 正大天晴药业集团股份有限公司 | 国药准字H20247246 | 2ml:0.5mg | Category B (乙) | XR03BAB165L023020201523 | NHSA |
| AstraZeneca Pty Ltd | 国药准字HJ20140475 | 2ml:1mg | Category B (乙) | XR03BAB165L023020278239 | NHSA |
| 健康元药业集团股份有限公司 | 国药准字H20203649 | 2ml:1mg | Category B (乙) | XR03BAB165L023020300545 | NHSA |
| 正大天晴药业集团股份有限公司 | 国药准字H20247246 | 2ml:0.5mg | Category B (乙) | XR03BAB165L023020301523 | NHSA |
| AstraZeneca Pty Ltd | 国药准字HJ20140475 | 2ml:1mg | Category B (乙) | XR03BAB165L023020378239 | NHSA |
| 健康元药业集团股份有限公司 | 国药准字H20203649 | 2ml:1mg | Category B (乙) | XR03BAB165L023020400545 | NHSA |
| 复星医药(徐州)有限公司 | 国药准字H20266032 | 2ml:1mg | Category B (乙) | XR03BAB165L023010186112 | 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: 7 filings and 7 distinct first applicants.
Generic 7
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 海南斯达制药有限公司;浙江赛默制药有限公司 | CYHS2601967 | Generic | 2026/08/11 | Not stated by source | CDE |
| 四川海梦智森生物制药有限公司;浙江赛默制药有限公司 | CYHS2601789 | Generic | 2026/07/27 | Not stated by source | CDE |
| 山东辰欣佛都药业股份有限公司 | CYHS2601209 | Generic | 2026/05/28 | Not stated by source | CDE |
| 山东禾琦制药有限公司;浙江赛默制药有限公司 | CYHS2600835 | Generic | 2026/04/11 | Not stated by source | CDE |
| 浙江高跖医药科技股份有限公司;浙江赛默制药有限公司 | CYHS2600246 | Generic | 2026/01/22 | Not stated by source | CDE |
| 石药集团中诺药业(石家庄)有限公司 | CYHS2600100 | Generic | 2026/01/09 | Not stated by source | CDE |
| 石家庄四药有限公司 | CYHS2504093 | Generic | 2025/11/28 | Not stated by source | CDE |
Loaded records: 6 filings and 6 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 海南斯达制药有限公司;浙江赛默制药有限公司 | CYHS2601967 | Generic | 2026/08/11 | Not stated by source | CDE |
| 四川海梦智森生物制药有限公司;浙江赛默制药有限公司 | CYHS2601789 | Generic | 2026/07/27 | Not stated by source | CDE |
| 山东辰欣佛都药业股份有限公司 | CYHS2601209 | Generic | 2026/05/28 | Not stated by source | CDE |
| 山东禾琦制药有限公司;浙江赛默制药有限公司 | CYHS2600835 | Generic | 2026/04/11 | Not stated by source | CDE |
| 浙江高跖医药科技股份有限公司;浙江赛默制药有限公司 | CYHS2600246 | Generic | 2026/01/22 | Not stated by source | CDE |
| 石药集团中诺药业(石家庄)有限公司 | CYHS2600100 | Generic | 2026/01/09 | Not stated by source | CDE |
Non-component matches: 0 companies with A status and 0 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 |
|---|---|---|---|---|---|---|
| No matching records were found in the currently loaded source data; coverage dates are listed below. | ||||||
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.
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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