Monthly
US$200
Billed every month
Apalutamide Tablets(阿帕他胺片)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 5 applicationsNo longer listed under review: 3 applicationsSupplement delivery: 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 holders9View records ↓
Under-review filings18View records ↓
This year’s generic filers7View records ↓
NHSA approval numbers4View records ↓
API companies with A status17View records ↓
Chemical-drug catalogue
Loaded records: 9 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 8 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 |
|---|---|---|---|---|---|---|
| 成都倍特药业股份有限公司 | 成都倍特药业股份有限公司 | 国药准字H20265150 | 2026/07/14 | 60mg | 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 |
| 正大天晴药业集团南京顺欣制药有限公司 | 正大天晴药业集团南京顺欣制药有限公司 | 国药准字H20264864 | 2026/06/17 | 60mg | 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 |
| 浙江诺得药业有限公司 | 浙江诺得药业有限公司 | 国药准字H20264862 | 2026/06/17 | 60mg | 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 |
| 浙江海正药业股份有限公司 | 浙江海正药业股份有限公司 | 国药准字H20264460 | 2026/05/19 | 60mg | 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 |
| 江西科睿药业有限公司 | 江西科睿药业有限公司 | 国药准字H20264465 | 2026/05/19 | 60mg | 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 |
| 四川科伦药业股份有限公司 | 四川科伦药业股份有限公司 | 国药准字H20253127 | 2025/01/14 | 60mg | 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 |
| 齐鲁制药（海南）有限公司 | 齐鲁制药（海南）有限公司 | 国药准字H20249668 | 2024/12/01 | 60mg | 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 |
| Janssen-Cilag International NV | Janssen Ortho,LLC；Catalent Pharma Solutions, LLC | 国药准字HJ20200029 | 2019/09/05 | 60mg | Imported originator drug (进口原研药品) | CDE |
| 成都苑东生物制药股份有限公司 | 成都苑东生物制药股份有限公司 | 国药准字H20254353 | 2025/05/27 | 60mg | 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.
NHSA drug codes
Loaded records: 4 distinct approval numbers and 3 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 四川科伦药业股份有限公司 | 国药准字H20253127 | 60mg | Category B (乙) | XL02BBA326A001010102180 | NHSA |
| 浙江海正药业股份有限公司 | 国药准字H20264460 | 60mg | Category B (乙) | XL02BBA326A001010104641 | NHSA |
| Janssen-Cilag International NV | H20190050 | 60mg | Category B (乙) | XL02BBA326A001010178537 | NHSA |
| 浙江海正药业股份有限公司 | 国药准字H20264460 | 60mg | Category B (乙) | XL02BBA326A001010204641 | NHSA |
| 浙江海正药业股份有限公司 | 国药准字H20264460 | 60mg | Category B (乙) | XL02BBA326A001010304641 | NHSA |
| Janssen-Cilag International NV | 国药准字HJ20200029 | 60mg | Category B (乙) | XL02BBA326A001020278537 | 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: 18 filings and 17 distinct first applicants.
Supplement 1 · Generic 16 · Import 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Janssen-Cilag International NV;Janssen Ortho LLC;Catalent Pharma Solutions LLC | JYHB2600530 | Supplement | 2026/09/22 | Not stated by source | CDE |
| 江苏和晨药业有限公司 | CYHS2602260 | Generic | 2026/09/10 | Not stated by source | CDE |
| 郑州德迈药业有限公司 | CYHS2601856 | Generic | 2026/08/03 | Not stated by source | CDE |
| Janssen-Cilag International NV;Janssen Ortho LLC;Catalent Pharma Solutions LLC;Xian Janssen Pharmaceutical Ltd. | JXHS2600061 | Import | 2026/06/10 | Not stated by source | CDE |
| 沈阳红旗制药有限公司;苏州二叶制药有限公司 | CYHS2600896 | Generic | 2026/04/18 | Not stated by source | CDE |
| 南京正大天晴制药有限公司 | CYHS2600764 | Generic | 2026/04/01 | Not stated by source | CDE |
| 江苏利泰尔药业有限公司 | CYHS2600413 | Generic | 2026/02/10 | Not stated by source | CDE |
| 江苏联环药业股份有限公司;药源生物科技（启东）有限公司 | CYHS2503875 | Generic | 2025/11/06 | Not stated by source | CDE |
| 昆山龙灯瑞迪制药有限公司 | CYHS2503601 | Generic | 2025/10/09 | Not stated by source | CDE |
| 无锡紫杉药业股份有限公司;上海创诺制药有限公司 | CYHS2503188 | Generic | 2025/08/30 | Not stated by source | CDE |
| 山西振东制药股份有限公司 | CYHS2504478 | Generic | 2025/12/30 | Not stated by source | CDE |
| 武汉九珑人福药业有限责任公司;重庆博腾药业有限公司 | CYHS2504153 | Generic | 2025/12/03 | Not stated by source | CDE |
| 山东新鲁医药科技有限公司;上海创诺制药有限公司 | CYHS2504064 | Generic | 2025/11/25 | Not stated by source | CDE |
| 重庆华森制药股份有限公司 | CYHS2503468 | Generic | 2025/09/19 | Not stated by source | CDE |
| 海南卓泰制药有限公司;上海创诺制药有限公司 | CYHS2503133 | Generic | 2025/08/27 | Not stated by source | CDE |
| 成都康弘药业集团股份有限公司;重庆博腾药业有限公司 | CYHS2503102 | Generic | 2025/08/23 | Not stated by source | CDE |
| 北京康立生医药技术开发有限公司;桐方药业（北京）有限公司 | CYHS2602665 | Generic | 2026/10/30 | Not stated by source | CDE |
| 广东东阳光药业股份有限公司;乳源东阳光药业有限公司 | CYHS2602717 | Generic | 2026/11/05 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 7 filings and 7 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏和晨药业有限公司 | CYHS2602260 | Generic | 2026/09/10 | Not stated by source | CDE |
| 郑州德迈药业有限公司 | CYHS2601856 | Generic | 2026/08/03 | Not stated by source | CDE |
| 沈阳红旗制药有限公司;苏州二叶制药有限公司 | CYHS2600896 | Generic | 2026/04/18 | Not stated by source | CDE |
| 南京正大天晴制药有限公司 | CYHS2600764 | Generic | 2026/04/01 | Not stated by source | CDE |
| 江苏利泰尔药业有限公司 | CYHS2600413 | Generic | 2026/02/10 | Not stated by source | CDE |
| 北京康立生医药技术开发有限公司;桐方药业（北京）有限公司 | CYHS2602665 | Generic | 2026/10/30 | Not stated by source | CDE |
| 广东东阳光药业股份有限公司;乳源东阳光药业有限公司 | CYHS2602717 | Generic | 2026/11/05 | 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 |
|---|---|---|---|---|---|---|
| 阿帕他胺 | 徐州万邦金桥制药有限公司 | Y20260000128 | I | Exact ingredient | 2026/03/13 | CDE |
| 阿帕他胺 | 浙江海正药业股份有限公司 | Y20260000070 | I | Exact ingredient | 2026/02/26 | CDE |
| 阿帕他胺 | 连云港贵科药业有限公司 | Y20250001169 | I | Exact ingredient | 2025/11/24 | CDE |
| 阿帕他胺 | 乳源东阳光药业有限公司 | Y20250000542 | A | Exact ingredient | 2026/10/30 | CDE |
| 阿帕他胺 | 湖北葛店人福药业有限责任公司 | Y20250000465 | I | Exact ingredient | 2025/06/04 | CDE |
| 阿帕他胺 | 山东新时代药业有限公司 | Y20250000313 | A | Exact ingredient | 2026/08/07 | CDE |
| 阿帕他胺 | 江苏希迪制药有限公司 | Y20240001342 | A | Exact ingredient | 2026/08/28 | CDE |
| 阿帕他胺 | 连云港润众制药有限公司 | Y20240001476 | A | Exact ingredient | 2026/05/28 | CDE |
| 阿帕他胺 | 重庆瑞泊莱制药有限公司 | Y20250000003 | A | Exact ingredient | 2026/09/16 | CDE |
| 阿帕他胺 | 徐州万邦金桥制药有限公司 | Y20240001470 | I | Exact ingredient | 2026/01/19 | CDE |
| 阿帕他胺 | 奥锐特药业股份有限公司 | Y20240000148 | A | Exact ingredient | 2026/03/26 | CDE |
| 阿帕他胺 | 山东诚汇双达药业有限公司 | Y20240001176 | A | Exact ingredient | 2026/03/12 | CDE |
| 阿帕他胺 | 浙江京圣药业有限公司 | Y20240000773 | A | Exact ingredient | 2026/01/05 | CDE |
| 阿帕他胺 | 四川仁安药业有限责任公司 | Y20240000748 | A | Exact ingredient | 2025/11/19 | CDE |
| 阿帕他胺 | 石家庄龙泽制药股份有限公司 | Y20240000638 | A | Exact ingredient | 2026/01/07 | CDE |
| 阿帕他胺 | 江西科睿药业有限公司 | Y20230001081 | A | Exact ingredient | 2026/06/27 | CDE |
| 阿帕他胺 | 山东安弘制药有限公司 | Y20230000241 | A | Exact ingredient | 2024/12/05 | CDE |
| 阿帕他胺 | 重庆博腾制药科技股份有限公司 | Y20230000753 | A | Exact ingredient | 2026/06/02 | CDE |
| 阿帕他胺 | 山西振东制药股份有限公司 | Y20230000373 | A | Exact ingredient | 2025/03/29 | CDE |
| 阿帕他胺 | 福建南方制药股份有限公司 | Y20220001262 | A | Exact ingredient | 2026/03/26 | CDE |
| 阿帕他胺 | 四川科伦药业股份有限公司 | Y20220001255 | A | Exact ingredient | 2024/08/05 | CDE |
| 阿帕他胺 | 四川青木制药有限公司 | Y20220000932 | A | Exact ingredient | 2024/06/21 | 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.
-
2026/11/05Accepted
广东东阳光药业股份有限公司;乳源东阳光药业有限公司
CYHS2602717
Fact date: 2026/11/05 · Site observation date: 2026/11/06
View source ↗ -
2026/11/03No longer listed under review
浙江诺得药业有限公司
CYHB2601618
Fact date: 2026/11/03 · Site observation date: 2026/11/03
Accepted: 2026/08/25
not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/11/02 (approval no.: —; approval date: 2026/10/30); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 4
NMPA · Table row 4 ↗ View source ↗ -
2026/10/30Supplement delivery
浙江诺得药业有限公司
CYHB2601618
Fact date: 2026/10/30 · Publication date: 2026/11/02 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 4 ↗ -
2026/10/30Accepted
北京康立生医药技术开发有限公司;桐方药业（北京）有限公司
CYHS2602665
Fact date: 2026/10/30 · Site observation date: 2026/10/31
View source ↗ -
2026/10/27No longer listed under review
湖北凯安晨医药科技有限公司;重庆博腾药业有限公司
CYHS2502375
Fact date: 2026/10/27 · Site observation date: 2026/10/27
Accepted: 2025/07/04
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/23No longer listed under review
华东医药（西安）博华制药有限公司;杭州中美华东制药有限公司
CYHS2502570
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2025/07/17
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/09/22Accepted
Janssen-Cilag International NV;Janssen Ortho LLC;Catalent Pharma Solutions LLC
JYHB2600530
Fact date: 2026/09/22 · Site observation date: 2026/10/21
View source ↗ -
2026/09/10Accepted
-
2026/08/25Accepted
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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