Monthly
US$200
Billed every month
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 12 applicationsNo longer listed under review: 1 application
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: 9 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 9 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 |
|---|---|---|---|---|---|---|
| 哈尔滨三联药业股份有限公司 | 兰西哈三联制药有限公司 | 国药准字H20265691 | 2026/08/25 | 5mg(按C17H18N6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 |
| 浙江麒正药业有限公司 | 浙江麒正药业有限公司 | 国药准字H20265641 | 2026/08/18 | 5mg(按C17H18N6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 |
| 浙江麒正药业有限公司 | 浙江麒正药业有限公司 | 国药准字H20265642 | 2026/08/18 | 15mg(以C17H18N6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 |
| 浙江麒正药业有限公司 | 浙江麒正药业有限公司 | 国药准字H20265640 | 2026/08/18 | 20mg(按C17H18N6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 |
| 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 | 国药准字H20264487 | 2026/05/19 | 20mg(按C17H18N6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 |
| 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 | 国药准字H20264492 | 2026/05/19 | 5mg(按C17H18N6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 |
| 昆山龙灯瑞迪制药有限公司 | 昆山龙灯瑞迪制药有限公司 | 国药准字H20263118 | 2026/01/14 | 5mg(按C17H18N6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 |
| 山东新时代药业有限公司 | 山东新时代药业有限公司 | 国药准字H20263014 | 2026/01/05 | 20mg(按C17H18N6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 |
| 山东新时代药业有限公司 | 山东新时代药业有限公司 | 国药准字H20263015 | 2026/01/05 | 5mg(按C17H18N6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 |
| 南京正科医药股份有限公司 | 南京正科医药股份有限公司 | 国药准字H20256448 | 2025/12/30 | 5mg(按C17H18N6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 |
| 江西科睿药业有限公司 | 江西科睿药业有限公司 | 国药准字H20256441 | 2025/12/30 | 5mg(按C17H18N6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H20249398 | 2024/11/15 | 5mg(按C17H18N6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 |
| 常州制药厂有限公司 | 常州制药厂有限公司 | 国药准字H20265696 | 2026/08/25 | 5mg(按C17H18N6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 |
| 哈尔滨三联药业股份有限公司 | 兰西哈三联制药有限公司 | 国药准字H20265692 | 2026/08/25 | 15mg(按C17H18N6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 |
| 常州制药厂有限公司 | 常州制药厂有限公司 | 国药准字H20265694 | 2026/08/25 | 15mg(按C17H18N6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 |
| 哈尔滨三联药业股份有限公司 | 兰西哈三联制药有限公司 | 国药准字H20265693 | 2026/08/25 | 20mg(按C17H18N6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 |
| 常州制药厂有限公司 | 常州制药厂有限公司 | 国药准字H20265695 | 2026/08/25 | 20mg(按C17H18N6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: 12 distinct approval numbers and 4 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 哈尔滨三联药业股份有限公司 | 国药准字H20265691 | 5mg(按C₁₇H₁₈N₆计) | Category B (乙) | XL01EJL356A001010103662 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20263015 | 5mg(按C₁₇H₁₈N₆计) | Category B (乙) | XL01EJL356A001010104188 | NHSA |
| Novartis Europharm Limited | 国药准字HJ20170134 | 5mg(按C₁₇H₁₈N₆计) | Category B (乙) | XL01EJL356A001010178672 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20263015 | 5mg(按C₁₇H₁₈N₆计) | Category B (乙) | XL01EJL356A001010204188 | NHSA |
| Novartis Europharm Limited | 国药准字HJ20170133 | 5mg(按C₁₇H₁₈N₆计) | Category B (乙) | XL01EJL356A001010278672 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20263015 | 5mg(按C₁₇H₁₈N₆计) | Category B (乙) | XL01EJL356A001010304188 | NHSA |
| Novartis Europharm Limited | 国药准字HJ20170134 | 5mg(按C₁₇H₁₈N₆计) | Category B (乙) | XL01EJL356A001010378672 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20263015 | 5mg(按C₁₇H₁₈N₆计) | Category B (乙) | XL01EJL356A001010404188 | NHSA |
| Novartis Europharm Limited | H20170132 | 5mg | Category B (乙) | XL01EJL356A001010478672 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20263015 | 5mg(按C₁₇H₁₈N₆计) | Category B (乙) | XL01EJL356A001010504188 | NHSA |
| Novartis Europharm Limited | 国药准字HJ20170133 | 5mg(按C₁₇H₁₈N₆计) | Category B (乙) | XL01EJL356A001010578672 | NHSA |
| 哈尔滨三联药业股份有限公司 | 国药准字H20265692 | 15mg(按C₁₇H₁₈N₆计) | Category B (乙) | XL01EJL356A001020103662 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20263014 | 20mg(按C₁₇H₁₈N₆计) | Category B (乙) | XL01EJL356A001020104188 | NHSA |
| Novartis Pharma Schweiz AG | H20170130 | 15mg | Category B (乙) | XL01EJL356A001020178672 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20263014 | 20mg(按C₁₇H₁₈N₆计) | Category B (乙) | XL01EJL356A001020204188 | NHSA |
| Novartis Europharm Limited | H20170131 | 15mg | Category B (乙) | XL01EJL356A001020278672 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20263014 | 20mg(按C₁₇H₁₈N₆计) | Category B (乙) | XL01EJL356A001020304188 | NHSA |
| Novartis Pharma Schweiz AG | H20170130 | 15mg | Category B (乙) | XL01EJL356A001020378672 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20263014 | 20mg(按C₁₇H₁₈N₆计) | Category B (乙) | XL01EJL356A001020404188 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20263014 | 20mg(按C₁₇H₁₈N₆计) | Category B (乙) | XL01EJL356A001020504188 | NHSA |
| 哈尔滨三联药业股份有限公司 | 国药准字H20265693 | 20mg(按C₁₇H₁₈N₆计) | Category B (乙) | XL01EJL356A001030103662 | NHSA |
| Novartis Pharma Schweiz AG | H20170128 | 20mg | Category B (乙) | XL01EJL356A001030178672 | NHSA |
| Novartis Pharma Schweiz AG | H20170127 | 20mg | Category B (乙) | XL01EJL356A001030278672 | NHSA |
| Novartis Pharma Schweiz AG | H20170128 | 20mg | Category B (乙) | XL01EJL356A001030378672 | NHSA |
| Novartis Pharma Schweiz AG | H20170127 | 20mg | Category B (乙) | XL01EJL356A001030478672 | 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: 27 filings and 16 distinct first applicants.
Generic 25 · Import 1 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏宣泰药业有限公司 | CYHS2602317 | Generic | 2026/09/17 | Not stated by source | CDE |
| 江苏宣泰药业有限公司 | CYHS2602316 | Generic | 2026/09/17 | Not stated by source | CDE |
| 江苏宣泰药业有限公司 | CYHS2602315 | Generic | 2026/09/17 | Not stated by source | CDE |
| 江苏宣泰药业有限公司 | CYHS2602314 | Generic | 2026/09/17 | Not stated by source | CDE |
| 南京正大天晴制药有限公司 | CYHS2201058 | Generic | 2022/07/14 | Not stated by source | CDE |
| 南京正大天晴制药有限公司 | CYHS2201057 | Generic | 2022/07/14 | Not stated by source | CDE |
| 南京正大天晴制药有限公司 | CYHS2201056 | Generic | 2022/07/14 | Not stated by source | CDE |
| 南京海纳制药有限公司 | CYHS2600982 | Generic | 2026/04/28 | Not stated by source | CDE |
| 新天地药业股份有限公司;山东药石药业有限公司 | CYHS2602561 | Generic | 2026/10/19 | Not stated by source | CDE |
| 新天地药业股份有限公司;山东药石药业有限公司 | CYHS2602560 | Generic | 2026/10/19 | Not stated by source | CDE |
| 新天地药业股份有限公司;山东药石药业有限公司 | CYHS2602559 | Generic | 2026/10/19 | Not stated by source | CDE |
| 山东罗欣药业集团股份有限公司 | CYHS2602129 | Generic | 2026/08/26 | Not stated by source | CDE |
| MSN LABORATORIES PRIVATE LIMITED (FORMULATIONS DIVISION II );Sino Universal Pharmaceutical Co. Ltd | JYHS2600015 | Import | 2026/08/12 | Not stated by source | CDE |
| Novartis Europharm Limited;Novartis Pharma Stein AG;Novartis Pharmaceutical Manufacturing LLC | JYHB2600374 | Supplement | 2026/07/10 | Not stated by source | CDE |
| 浙江海正药业股份有限公司 | CYHS2600913 | Generic | 2026/04/21 | Not stated by source | CDE |
| 湖北长江瑞益医药科技有限公司;重庆博腾药业有限公司 | CYHS2600763 | Generic | 2026/04/01 | Not stated by source | CDE |
| 重庆药友制药有限责任公司 | CYHS2600706 | Generic | 2026/03/24 | Not stated by source | CDE |
| 北京福元医药股份有限公司 | CYHS2504053 | Generic | 2025/11/25 | Not stated by source | CDE |
| 齐鲁制药有限公司 | CYHS2503012 | Generic | 2025/08/15 | Not stated by source | CDE |
| 齐鲁制药有限公司 | CYHS2503011 | Generic | 2025/08/15 | Not stated by source | CDE |
| 齐鲁制药有限公司 | CYHS2503010 | Generic | 2025/08/15 | Not stated by source | CDE |
| 浙江华海制药科技有限公司 | CYHS2500756 | Generic | 2025/02/17 | Not stated by source | CDE |
| 重庆华森制药股份有限公司 | CYHS2400363 | Generic | 2024/01/27 | Not stated by source | CDE |
| 湖北民康制药有限公司 | CYHS2602615 | Generic | 2026/10/26 | Not stated by source | CDE |
| 湖北民康制药有限公司 | CYHS2602614 | Generic | 2026/10/26 | Not stated by source | CDE |
| 湖北民康制药有限公司 | CYHS2602613 | Generic | 2026/10/26 | Not stated by source | CDE |
| 湖南科伦制药有限公司 | CYHS2602630 | Generic | 2026/10/27 | Not stated by source | CDE |
Loaded records: 16 filings and 9 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏宣泰药业有限公司 | CYHS2602317 | Generic | 2026/09/17 | Not stated by source | CDE |
| 江苏宣泰药业有限公司 | CYHS2602316 | Generic | 2026/09/17 | Not stated by source | CDE |
| 江苏宣泰药业有限公司 | CYHS2602315 | Generic | 2026/09/17 | Not stated by source | CDE |
| 江苏宣泰药业有限公司 | CYHS2602314 | Generic | 2026/09/17 | Not stated by source | CDE |
| 南京海纳制药有限公司 | CYHS2600982 | Generic | 2026/04/28 | Not stated by source | CDE |
| 新天地药业股份有限公司;山东药石药业有限公司 | CYHS2602561 | Generic | 2026/10/19 | Not stated by source | CDE |
| 新天地药业股份有限公司;山东药石药业有限公司 | CYHS2602560 | Generic | 2026/10/19 | Not stated by source | CDE |
| 新天地药业股份有限公司;山东药石药业有限公司 | CYHS2602559 | Generic | 2026/10/19 | Not stated by source | CDE |
| 山东罗欣药业集团股份有限公司 | CYHS2602129 | Generic | 2026/08/26 | Not stated by source | CDE |
| 浙江海正药业股份有限公司 | CYHS2600913 | Generic | 2026/04/21 | Not stated by source | CDE |
| 湖北长江瑞益医药科技有限公司;重庆博腾药业有限公司 | CYHS2600763 | Generic | 2026/04/01 | Not stated by source | CDE |
| 重庆药友制药有限责任公司 | CYHS2600706 | Generic | 2026/03/24 | Not stated by source | CDE |
| 湖北民康制药有限公司 | CYHS2602615 | Generic | 2026/10/26 | Not stated by source | CDE |
| 湖北民康制药有限公司 | CYHS2602614 | Generic | 2026/10/26 | Not stated by source | CDE |
| 湖北民康制药有限公司 | CYHS2602613 | Generic | 2026/10/26 | Not stated by source | CDE |
| 湖南科伦制药有限公司 | CYHS2602630 | Generic | 2026/10/27 | Not stated by source | CDE |
Non-component matches: 11 companies with A status and 10 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 |
|---|---|---|---|---|---|---|
| 磷酸芦可替尼 | 湖北葛店人福药业有限责任公司 | Y20260000231 | I | Exact ingredient | 2026/04/23 | CDE |
| 磷酸芦可替尼 | 山东罗欣药业集团恒欣药业有限公司 | Y20260000241 | I | Exact ingredient | 2026/04/02 | CDE |
| 磷酸芦可替尼 | 南通常佑药业科技有限公司 | Y20260000092 | I | Exact ingredient | 2026/03/20 | CDE |
| 磷酸芦可替尼 | 湖北美林药业有限公司 | Y20260000088 | I | Exact ingredient | 2026/02/28 | CDE |
| 磷酸芦可替尼 | 湘北威尔曼制药股份有限公司 | Y20260000039 | I | Exact ingredient | 2026/02/09 | CDE |
| 磷酸芦可替尼 | MSN Laboratories Private Limited, Unit-III | Y20250000374 | I | Exact ingredient | 2025/12/03 | CDE |
| 磷酸芦可替尼 | 重庆凯林制药有限公司 | Y20250000835 | I | Exact ingredient | 2025/09/26 | CDE |
| 磷酸芦可替尼 | 山东诚汇双达药业有限公司 | Y20250000861 | I | Exact ingredient | 2025/08/21 | CDE |
| 磷酸芦可替尼 | 新天地药业股份有限公司 | Y20250000430 | I | Exact ingredient | 2025/05/16 | CDE |
| 磷酸芦可替尼 | 齐鲁制药有限公司 | Y20250000174 | A | Exact ingredient | 2026/09/14 | CDE |
| 磷酸芦可替尼 | 四川科伦药业股份有限公司 | Y20250000039 | A | Exact ingredient | 2026/07/01 | CDE |
| 磷酸芦可替尼 | 浙江华海药业股份有限公司 | Y20250000073 | A | Exact ingredient | 2026/09/14 | CDE |
| 磷酸芦可替尼 | 兰西哈三联制药有限公司 | Y20240001324 | A | Exact ingredient | 2026/08/07 | CDE |
| 磷酸芦可替尼 | 河北鼎泰制药有限公司 | Y20240001105 | A | Exact ingredient | 2026/06/16 | CDE |
| 磷酸芦可替尼 | 浙江奥翔药业股份有限公司 | Y20240001130 | A | Exact ingredient | 2026/03/30 | CDE |
| 磷酸芦可替尼 | 江西科睿药业有限公司 | Y20240000491 | A | Exact ingredient | 2025/12/30 | CDE |
| 磷酸芦可替尼 | 常州制药厂有限公司 | Y20230000729 | A | Exact ingredient | 2025/04/07 | CDE |
| 磷酸芦可替尼 | 山东新时代药业有限公司 | Y20230000288 | A | Exact ingredient | 2025/03/21 | CDE |
| 磷酸芦可替尼 | 四川青木制药有限公司 | Y20230000081 | A | Exact ingredient | 2024/12/13 | CDE |
| 磷酸芦可替尼 | 重庆胜凯制药有限公司 | Y20220000951 | A | Exact ingredient | 2025/11/11 | CDE |
| 磷酸芦可替尼 | 南京正大天晴制药有限公司 | Y20220000415 | I | Exact ingredient | 2022/06/20 | 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.
CYHS2500409
Fact date: 2026/10/28 · Site observation date: 2026/10/28
Accepted: 2025/01/22
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHS2501334 · 国药准字H20266416
Fact date: 2026/10/26 · Publication date: 2026/10/27 · Site observation date: 2026/11/03
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.
View source · Table row 39 ↗CYHS2602561
Fact date: 2026/10/19 · Site observation date: 2026/10/22
View source ↗CYHS2602560
Fact date: 2026/10/19 · Site observation date: 2026/10/22
View source ↗CYHS2602559
Fact date: 2026/10/19 · Site observation date: 2026/10/22
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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