药格局YaoGeJu

Public drug landscapesDrug landscape

Ruxolitinib Phosphate Tablets(磷酸芦可替尼片)

Companies, stages and changes, with each record available on this page.

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Complete CDE snapshot
2026/11/10 07:27
Matching scope
Same generic name; dosage forms and combinations kept separate

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.

Chemical-drug catalogue

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 holderManufacturerApproval numberApprovedStrength / specificationCatalogue 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.

NHSA drug codes

Loaded records: 12 distinct approval numbers and 4 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView 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) XL01EJL356A001010103662NHSA
山东新时代药业有限公司 国药准字H20263015 5mg(按C₁₇H₁₈N₆计) Category B (乙) XL01EJL356A001010104188NHSA
Novartis Europharm Limited 国药准字HJ20170134 5mg(按C₁₇H₁₈N₆计) Category B (乙) XL01EJL356A001010178672NHSA
山东新时代药业有限公司 国药准字H20263015 5mg(按C₁₇H₁₈N₆计) Category B (乙) XL01EJL356A001010204188NHSA
Novartis Europharm Limited 国药准字HJ20170133 5mg(按C₁₇H₁₈N₆计) Category B (乙) XL01EJL356A001010278672NHSA
山东新时代药业有限公司 国药准字H20263015 5mg(按C₁₇H₁₈N₆计) Category B (乙) XL01EJL356A001010304188NHSA
Novartis Europharm Limited 国药准字HJ20170134 5mg(按C₁₇H₁₈N₆计) Category B (乙) XL01EJL356A001010378672NHSA
山东新时代药业有限公司 国药准字H20263015 5mg(按C₁₇H₁₈N₆计) Category B (乙) XL01EJL356A001010404188NHSA
Novartis Europharm Limited H20170132 5mg Category B (乙) XL01EJL356A001010478672NHSA
山东新时代药业有限公司 国药准字H20263015 5mg(按C₁₇H₁₈N₆计) Category B (乙) XL01EJL356A001010504188NHSA
Novartis Europharm Limited 国药准字HJ20170133 5mg(按C₁₇H₁₈N₆计) Category B (乙) XL01EJL356A001010578672NHSA
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) XL01EJL356A001020103662NHSA
山东新时代药业有限公司 国药准字H20263014 20mg(按C₁₇H₁₈N₆计) Category B (乙) XL01EJL356A001020104188NHSA
Novartis Pharma Schweiz AG H20170130 15mg Category B (乙) XL01EJL356A001020178672NHSA
山东新时代药业有限公司 国药准字H20263014 20mg(按C₁₇H₁₈N₆计) Category B (乙) XL01EJL356A001020204188NHSA
Novartis Europharm Limited H20170131 15mg Category B (乙) XL01EJL356A001020278672NHSA
山东新时代药业有限公司 国药准字H20263014 20mg(按C₁₇H₁₈N₆计) Category B (乙) XL01EJL356A001020304188NHSA
Novartis Pharma Schweiz AG H20170130 15mg Category B (乙) XL01EJL356A001020378672NHSA
山东新时代药业有限公司 国药准字H20263014 20mg(按C₁₇H₁₈N₆计) Category B (乙) XL01EJL356A001020404188NHSA
山东新时代药业有限公司 国药准字H20263014 20mg(按C₁₇H₁₈N₆计) Category B (乙) XL01EJL356A001020504188NHSA
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) XL01EJL356A001030103662NHSA
Novartis Pharma Schweiz AG H20170128 20mg Category B (乙) XL01EJL356A001030178672NHSA
Novartis Pharma Schweiz AG H20170127 20mg Category B (乙) XL01EJL356A001030278672NHSA
Novartis Pharma Schweiz AG H20170128 20mg Category B (乙) XL01EJL356A001030378672NHSA
Novartis Pharma Schweiz AG H20170127 20mg Category B (乙) XL01EJL356A001030478672NHSA

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: 27 filings and 16 distinct first applicants.

Generic 25 · Import 1 · Supplement 1

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
江苏宣泰药业有限公司 CYHS2602317 Generic2026/09/17Not stated by sourceCDE
江苏宣泰药业有限公司 CYHS2602316 Generic2026/09/17Not stated by sourceCDE
江苏宣泰药业有限公司 CYHS2602315 Generic2026/09/17Not stated by sourceCDE
江苏宣泰药业有限公司 CYHS2602314 Generic2026/09/17Not stated by sourceCDE
南京正大天晴制药有限公司 CYHS2201058 Generic2022/07/14Not stated by sourceCDE
南京正大天晴制药有限公司 CYHS2201057 Generic2022/07/14Not stated by sourceCDE
南京正大天晴制药有限公司 CYHS2201056 Generic2022/07/14Not stated by sourceCDE
南京海纳制药有限公司 CYHS2600982 Generic2026/04/28Not stated by sourceCDE
新天地药业股份有限公司;山东药石药业有限公司 CYHS2602561 Generic2026/10/19Not stated by sourceCDE
新天地药业股份有限公司;山东药石药业有限公司 CYHS2602560 Generic2026/10/19Not stated by sourceCDE
新天地药业股份有限公司;山东药石药业有限公司 CYHS2602559 Generic2026/10/19Not stated by sourceCDE
山东罗欣药业集团股份有限公司 CYHS2602129 Generic2026/08/26Not stated by sourceCDE
MSN LABORATORIES PRIVATE LIMITED (FORMULATIONS DIVISION II );Sino Universal Pharmaceutical Co. Ltd JYHS2600015 Import2026/08/12Not stated by sourceCDE
Novartis Europharm Limited;Novartis Pharma Stein AG;Novartis Pharmaceutical Manufacturing LLC JYHB2600374 Supplement2026/07/10Not stated by sourceCDE
浙江海正药业股份有限公司 CYHS2600913 Generic2026/04/21Not stated by sourceCDE
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 Generic2026/04/01Not stated by sourceCDE
重庆药友制药有限责任公司 CYHS2600706 Generic2026/03/24Not stated by sourceCDE
北京福元医药股份有限公司 CYHS2504053 Generic2025/11/25Not stated by sourceCDE
齐鲁制药有限公司 CYHS2503012 Generic2025/08/15Not stated by sourceCDE
齐鲁制药有限公司 CYHS2503011 Generic2025/08/15Not stated by sourceCDE
齐鲁制药有限公司 CYHS2503010 Generic2025/08/15Not stated by sourceCDE
浙江华海制药科技有限公司 CYHS2500756 Generic2025/02/17Not stated by sourceCDE
重庆华森制药股份有限公司 CYHS2400363 Generic2024/01/27Not stated by sourceCDE
湖北民康制药有限公司 CYHS2602615 Generic2026/10/26Not stated by sourceCDE
湖北民康制药有限公司 CYHS2602614 Generic2026/10/26Not stated by sourceCDE
湖北民康制药有限公司 CYHS2602613 Generic2026/10/26Not stated by sourceCDE
湖南科伦制药有限公司 CYHS2602630 Generic2026/10/27Not stated by sourceCDE
New generic filings in 2026

Loaded records: 16 filings and 9 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
江苏宣泰药业有限公司 CYHS2602317 Generic2026/09/17Not stated by sourceCDE
江苏宣泰药业有限公司 CYHS2602316 Generic2026/09/17Not stated by sourceCDE
江苏宣泰药业有限公司 CYHS2602315 Generic2026/09/17Not stated by sourceCDE
江苏宣泰药业有限公司 CYHS2602314 Generic2026/09/17Not stated by sourceCDE
南京海纳制药有限公司 CYHS2600982 Generic2026/04/28Not stated by sourceCDE
新天地药业股份有限公司;山东药石药业有限公司 CYHS2602561 Generic2026/10/19Not stated by sourceCDE
新天地药业股份有限公司;山东药石药业有限公司 CYHS2602560 Generic2026/10/19Not stated by sourceCDE
新天地药业股份有限公司;山东药石药业有限公司 CYHS2602559 Generic2026/10/19Not stated by sourceCDE
山东罗欣药业集团股份有限公司 CYHS2602129 Generic2026/08/26Not stated by sourceCDE
浙江海正药业股份有限公司 CYHS2600913 Generic2026/04/21Not stated by sourceCDE
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 Generic2026/04/01Not stated by sourceCDE
重庆药友制药有限责任公司 CYHS2600706 Generic2026/03/24Not stated by sourceCDE
湖北民康制药有限公司 CYHS2602615 Generic2026/10/26Not stated by sourceCDE
湖北民康制药有限公司 CYHS2602614 Generic2026/10/26Not stated by sourceCDE
湖北民康制药有限公司 CYHS2602613 Generic2026/10/26Not stated by sourceCDE
湖南科伦制药有限公司 CYHS2602630 Generic2026/10/27Not stated by sourceCDE
API registrations

Non-component matches: 11 companies with A status and 10 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
磷酸芦可替尼湖北葛店人福药业有限责任公司Y20260000231IExact ingredient2026/04/23CDE
磷酸芦可替尼山东罗欣药业集团恒欣药业有限公司Y20260000241IExact ingredient2026/04/02CDE
磷酸芦可替尼南通常佑药业科技有限公司Y20260000092IExact ingredient2026/03/20CDE
磷酸芦可替尼湖北美林药业有限公司Y20260000088IExact ingredient2026/02/28CDE
磷酸芦可替尼湘北威尔曼制药股份有限公司Y20260000039IExact ingredient2026/02/09CDE
磷酸芦可替尼MSN Laboratories Private Limited, Unit-IIIY20250000374IExact ingredient2025/12/03CDE
磷酸芦可替尼重庆凯林制药有限公司Y20250000835IExact ingredient2025/09/26CDE
磷酸芦可替尼山东诚汇双达药业有限公司Y20250000861IExact ingredient2025/08/21CDE
磷酸芦可替尼新天地药业股份有限公司Y20250000430IExact ingredient2025/05/16CDE
磷酸芦可替尼齐鲁制药有限公司Y20250000174AExact ingredient2026/09/14CDE
磷酸芦可替尼四川科伦药业股份有限公司Y20250000039AExact ingredient2026/07/01CDE
磷酸芦可替尼浙江华海药业股份有限公司Y20250000073AExact ingredient2026/09/14CDE
磷酸芦可替尼兰西哈三联制药有限公司Y20240001324AExact ingredient2026/08/07CDE
磷酸芦可替尼河北鼎泰制药有限公司Y20240001105AExact ingredient2026/06/16CDE
磷酸芦可替尼浙江奥翔药业股份有限公司Y20240001130AExact ingredient2026/03/30CDE
磷酸芦可替尼江西科睿药业有限公司Y20240000491AExact ingredient2025/12/30CDE
磷酸芦可替尼常州制药厂有限公司Y20230000729AExact ingredient2025/04/07CDE
磷酸芦可替尼山东新时代药业有限公司Y20230000288AExact ingredient2025/03/21CDE
磷酸芦可替尼四川青木制药有限公司Y20230000081AExact ingredient2024/12/13CDE
磷酸芦可替尼重庆胜凯制药有限公司Y20220000951AExact ingredient2025/11/11CDE
磷酸芦可替尼南京正大天晴制药有限公司Y20220000415IExact ingredient2022/06/20CDE

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.

  1. 2026/10/28No longer listed under review

    成都倍特药业股份有限公司

    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 ↗
  2. 2026/10/27Accepted

    湖南科伦制药有限公司

    CYHS2602630

    Fact date: 2026/10/27 · Site observation date: 2026/10/28

    View source ↗
  3. 2026/10/26Marketing application approved

    上海创诺制药有限公司

    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 ↗
  4. 2026/10/26Accepted

    湖北民康制药有限公司

    CYHS2602615

    Fact date: 2026/10/26 · Site observation date: 2026/10/27

    View source ↗
  5. 2026/10/26Accepted

    湖北民康制药有限公司

    CYHS2602614

    Fact date: 2026/10/26 · Site observation date: 2026/10/27

    View source ↗
  6. 2026/10/26Accepted

    湖北民康制药有限公司

    CYHS2602613

    Fact date: 2026/10/26 · Site observation date: 2026/10/27

    View source ↗
  7. 2026/10/19Accepted

    新天地药业股份有限公司;山东药石药业有限公司

    CYHS2602561

    Fact date: 2026/10/19 · Site observation date: 2026/10/22

    View source ↗
  8. 2026/10/19Accepted

    新天地药业股份有限公司;山东药石药业有限公司

    CYHS2602560

    Fact date: 2026/10/19 · Site observation date: 2026/10/22

    View source ↗
  9. 2026/10/19Accepted

    新天地药业股份有限公司;山东药石药业有限公司

    CYHS2602559

    Fact date: 2026/10/19 · Site observation date: 2026/10/22

    View source ↗
  10. 2026/09/17Accepted

    江苏宣泰药业有限公司

    CYHS2602317

    Fact date: 2026/09/17 · Site observation date: 2026/10/21

    View source ↗
  11. 2026/09/17Accepted

    江苏宣泰药业有限公司

    CYHS2602316

    Fact date: 2026/09/17 · Site observation date: 2026/10/21

    View source ↗
  12. 2026/09/17Accepted

    江苏宣泰药业有限公司

    CYHS2602315

    Fact date: 2026/09/17 · Site observation date: 2026/10/21

    View source ↗
  13. 2026/09/17Accepted

    江苏宣泰药业有限公司

    CYHS2602314

    Fact date: 2026/09/17 · Site observation date: 2026/10/21

    View source ↗
  14. 2026/08/26Accepted

    山东罗欣药业集团股份有限公司

    CYHS2602129

    Fact date: 2026/08/26 · Site observation date: 2026/10/22

    View source ↗

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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