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Ixazomib Citrate Capsules(枸橼酸伊沙佐米胶囊)

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

Last 90 days: Accepted: 3 applicationsSupplement delivery: 3 applications

Current coverage may be incomplete

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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: 2 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 1 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
齐鲁制药有限公司齐鲁制药有限公司 国药准字H20253310 2025/01/24 2.3mg(按14H19BCl2N2O4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
齐鲁制药有限公司齐鲁制药有限公司 国药准字H20253308 2025/01/24 4mg(按C14H19BCl2N2O4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
齐鲁制药有限公司齐鲁制药有限公司 国药准字H20253309 2025/01/24 3mg(按C14H19BCl2N2O4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
Takeda Pharma A/SHaupt Pharma Amareg GmbH H20180012 2018/04/12 2.3mg Imported originator drug (进口原研药品) CDE
Takeda Pharma A/SHaupt Pharma Amareg GmbH H20180011 2018/04/12 3mg Imported originator drug (进口原研药品) CDE
Takeda Pharma A/SHaupt Pharma Amareg GmbH H20180010 2018/04/12 4mg 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.

NHSA drug codes

Loaded records: 3 distinct approval numbers and 1 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Takeda Pharma A/S 国药准字HJ20180012 2.3mg(按C₁₄H₁₉BCl₂N₂O₄计 ) Category B (乙) XL01XGY306E001010179422NHSA
Takeda Pharma A/S 国药准字HJ20180011 3mg(按C₁₄H₁₉BCl₂N₂O₄计 ) Category B (乙) XL01XGY306E001020179422NHSA
Takeda Pharma A/S 国药准字HJ20180010 4mg(按C₁₄H₁₉BCl₂N₂O₄计 ) Category B (乙) XL01XGY306E001030179422NHSA

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: 7 filings and 3 distinct first applicants.

Generic 7

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
合肥亿帆生物制药有限公司;东曜药业有限公司 CYHS2602459 Generic2026/10/09Not stated by sourceCDE
合肥亿帆生物制药有限公司;东曜药业有限公司 CYHS2602458 Generic2026/10/09Not stated by sourceCDE
合肥亿帆生物制药有限公司;东曜药业有限公司 CYHS2602457 Generic2026/10/09Not stated by sourceCDE
正大天晴药业集团股份有限公司 CYHS2601883 Generic2026/08/03Not stated by sourceCDE
正大天晴药业集团股份有限公司 CYHS2601882 Generic2026/08/03Not stated by sourceCDE
正大天晴药业集团股份有限公司 CYHS2601881 Generic2026/08/03Not stated by sourceCDE
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 CYHS2504526 Generic2026/01/04Not stated by sourceCDE
New generic filings in 2026

Loaded records: 7 filings and 3 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
合肥亿帆生物制药有限公司;东曜药业有限公司 CYHS2602459 Generic2026/10/09Not stated by sourceCDE
合肥亿帆生物制药有限公司;东曜药业有限公司 CYHS2602458 Generic2026/10/09Not stated by sourceCDE
合肥亿帆生物制药有限公司;东曜药业有限公司 CYHS2602457 Generic2026/10/09Not stated by sourceCDE
正大天晴药业集团股份有限公司 CYHS2601883 Generic2026/08/03Not stated by sourceCDE
正大天晴药业集团股份有限公司 CYHS2601882 Generic2026/08/03Not stated by sourceCDE
正大天晴药业集团股份有限公司 CYHS2601881 Generic2026/08/03Not stated by sourceCDE
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 CYHS2504526 Generic2026/01/04Not stated by sourceCDE
API registrations

Non-component matches: 6 companies with A status and 6 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
枸橼酸伊沙佐米深圳万乐药业有限公司Y20250001384IExact ingredient2025/12/31CDE
枸橼酸伊沙佐米重庆凯林制药有限公司Y20250000999IExact ingredient2025/12/19CDE
枸橼酸伊沙佐米连云港润众制药有限公司Y20250001105IExact ingredient2025/10/23CDE
枸橼酸伊沙佐米华东医药(西安)博华制药有限公司Y20250000693IExact ingredient2025/08/11CDE
枸橼酸伊沙佐米四川青木制药有限公司Y20250000549AExact ingredient2026/11/05CDE
枸橼酸伊沙佐米宿州亿帆药业有限公司Y20250000670IExact ingredient2025/07/08CDE
枸橼酸伊沙佐米四川汇宇制药股份有限公司Y20250000534AExact ingredient2026/10/21CDE
枸橼酸伊沙佐米江苏天士力帝益药业有限公司Y20250000103AExact ingredient2026/06/30CDE
枸橼酸伊沙佐米山东新时代药业有限公司Y20240001475AExact ingredient2026/07/21CDE
枸橼酸伊沙佐米重庆迈德凯医药有限公司Y20240000575IExact ingredient2025/08/29CDE
枸橼酸伊沙佐米齐鲁制药有限公司Y20230000721AExact ingredient2026/05/22CDE
枸橼酸伊沙佐米四川科伦药业股份有限公司Y20230000110AExact ingredient2024/11/21CDE

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. 2026/10/20Supplement delivery

    武田(中国)国际贸易有限公司

    JYHB2600410

    Fact date: 2026/10/20 · Publication date: 2026/10/21 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 22 ↗
  2. 2026/10/20Supplement delivery

    武田(中国)国际贸易有限公司

    JYHB2600409

    Fact date: 2026/10/20 · Publication date: 2026/10/21 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 21 ↗
  3. 2026/10/20Supplement delivery

    武田(中国)国际贸易有限公司

    JYHB2600408

    Fact date: 2026/10/20 · Publication date: 2026/10/21 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 20 ↗
  4. 2026/10/09Accepted

    合肥亿帆生物制药有限公司;东曜药业有限公司

    CYHS2602459

    Fact date: 2026/10/09 · Site observation date: 2026/10/22

    View source ↗
  5. 2026/10/09Accepted

    合肥亿帆生物制药有限公司;东曜药业有限公司

    CYHS2602458

    Fact date: 2026/10/09 · Site observation date: 2026/10/22

    View source ↗
  6. 2026/10/09Accepted

    合肥亿帆生物制药有限公司;东曜药业有限公司

    CYHS2602457

    Fact date: 2026/10/09 · 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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