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Cefditoren Pivoxil Granules(头孢托仑匹酯颗粒)

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

Last 90 days: Notification delivery: 1 application

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
福安药业集团庆余堂制药有限公司福安药业集团庆余堂制药有限公司 国药准字H20256029 2025/11/25 50mg(按C19H18N6O5S3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
福安药业集团庆余堂制药有限公司福安药业集团庆余堂制药有限公司 国药准字H20256028 2025/11/25 30mg(按C19H18N6O5S3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
Meiji Seika Pharma Co., Ltd.Meiji Seika Pharma Co., Ltd. Odawara Plant H20150211 2015/04/29 50mg(效价)/0.5g/袋 Imported originator drug (进口原研药品) CDE
Meiji Seika Pharma Co., Ltd.Meiji Seika Pharma Co., Ltd. Odawara Plant H20150212 2015/04/29 30mg(效价)/0.3g/袋 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: 8 distinct approval numbers and 3 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Meiji Seika Pharma Co., Ltd. 国药准字J20150126 30mg(效价)/0.3g/袋 Not stated by sourceXJ01DDT101N001010100483NHSA
福安药业集团庆余堂制药有限公司 国药准字H20256028 30mg(按C₁₉H₁₈N₆O₅S₃计) Not stated by sourceXJ01DDT101N001010101877NHSA
海南葫芦娃药业集团股份有限公司 国药准字H20265443 30mg(按C₁₉H₁₈N₆O₅S₃ 计) Not stated by sourceXJ01DDT101N001010105789NHSA
Meiji Seika Pharma Co., Ltd. 国药准字HJ20150417 30mg(以头孢托仑计) Not stated by sourceXJ01DDT101N001010179527NHSA
海南葫芦娃药业集团股份有限公司 国药准字H20265443 30mg(按C₁₉H₁₈N₆O₅S₃ 计) Not stated by sourceXJ01DDT101N001010205789NHSA
Meiji Seika Pharma Co., Ltd. 国药准字J20150125 50mg(效价)/0.5g/袋 Not stated by sourceXJ01DDT101N001020100483NHSA
福安药业集团庆余堂制药有限公司 国药准字H20256029 50mg(按C₁₉H₁₈N₆O₅S₃计) Not stated by sourceXJ01DDT101N001020101877NHSA
海南葫芦娃药业集团股份有限公司 国药准字H20265440 50mg(按C₁₉H₁₈N₆O₅S₃计) Not stated by sourceXJ01DDT101N001020105789NHSA
Meiji Seika Pharma Co.,Ltd. 国药准字HJ20150470 50mg(以头孢托仑计) Not stated by sourceXJ01DDT101N001020179527NHSA
海南葫芦娃药业集团股份有限公司 国药准字H20265440 50mg(按C₁₉H₁₈N₆O₅S₃计) Not stated by sourceXJ01DDT101N001020205789NHSA
海南葫芦娃药业集团股份有限公司 国药准字H20265440 50mg(按C₁₉H₁₈N₆O₅S₃计) Not stated by sourceXJ01DDT101N001020305789NHSA

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 10 distinct first applicants.

Generic 18

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
山东鲁抗医药股份有限公司 CYHS2601616 Generic2026/07/07Not stated by sourceCDE
山东鲁抗医药股份有限公司 CYHS2601614 Generic2026/07/07Not stated by sourceCDE
苏州二叶制药有限公司;齐鲁安替制药有限公司 CYHS2504329 Generic2025/12/19Not stated by sourceCDE
苏州二叶制药有限公司;齐鲁安替制药有限公司 CYHS2504328 Generic2025/12/19Not stated by sourceCDE
苏州盛达药业有限公司;苏州第三制药厂有限责任公司 CYHS2600736 Generic2026/03/28Not stated by sourceCDE
苏州盛达药业有限公司;苏州第三制药厂有限责任公司 CYHS2600735 Generic2026/03/28Not stated by sourceCDE
淏方(福建)生物科技有限公司;苏州第三制药厂有限责任公司 CYHS2600652 Generic2026/03/12Not stated by sourceCDE
广州仁恒医药科技股份有限公司;苏州第三制药厂有限责任公司 CYHS2504528 Generic2026/01/04Not stated by sourceCDE
广州仁恒医药科技股份有限公司;苏州第三制药厂有限责任公司 CYHS2504527 Generic2026/01/04Not stated by sourceCDE
福建省融恒医药有限公司;苏州第三制药厂有限责任公司 CYHS2503649 Generic2025/10/14Not stated by sourceCDE
河南君善生物技术有限公司;广州白云山天心制药股份有限公司 CYHS2600526 Generic2026/02/25Not stated by sourceCDE
河南君善生物技术有限公司;广州白云山天心制药股份有限公司 CYHS2600525 Generic2026/02/25Not stated by sourceCDE
齐鲁安替制药有限公司 CYHS2600384 Generic2026/02/05Not stated by sourceCDE
齐鲁安替制药有限公司 CYHS2600383 Generic2026/02/05Not stated by sourceCDE
湖南状元制药有限公司;广州白云山天心制药股份有限公司 CYHS2503920 Generic2025/11/11Not stated by sourceCDE
湖南状元制药有限公司;广州白云山天心制药股份有限公司 CYHS2503919 Generic2025/11/11Not stated by sourceCDE
沐源(安徽)药业有限公司;福安药业集团庆余堂制药有限公司 CYHS2502837 Generic2025/08/06Not stated by sourceCDE
沐源(安徽)药业有限公司;福安药业集团庆余堂制药有限公司 CYHS2502836 Generic2025/08/06Not stated by sourceCDE
New generic filings in 2026

Loaded records: 11 filings and 6 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
山东鲁抗医药股份有限公司 CYHS2601616 Generic2026/07/07Not stated by sourceCDE
山东鲁抗医药股份有限公司 CYHS2601614 Generic2026/07/07Not stated by sourceCDE
苏州盛达药业有限公司;苏州第三制药厂有限责任公司 CYHS2600736 Generic2026/03/28Not stated by sourceCDE
苏州盛达药业有限公司;苏州第三制药厂有限责任公司 CYHS2600735 Generic2026/03/28Not stated by sourceCDE
淏方(福建)生物科技有限公司;苏州第三制药厂有限责任公司 CYHS2600652 Generic2026/03/12Not stated by sourceCDE
广州仁恒医药科技股份有限公司;苏州第三制药厂有限责任公司 CYHS2504528 Generic2026/01/04Not stated by sourceCDE
广州仁恒医药科技股份有限公司;苏州第三制药厂有限责任公司 CYHS2504527 Generic2026/01/04Not stated by sourceCDE
河南君善生物技术有限公司;广州白云山天心制药股份有限公司 CYHS2600526 Generic2026/02/25Not stated by sourceCDE
河南君善生物技术有限公司;广州白云山天心制药股份有限公司 CYHS2600525 Generic2026/02/25Not stated by sourceCDE
齐鲁安替制药有限公司 CYHS2600384 Generic2026/02/05Not stated by sourceCDE
齐鲁安替制药有限公司 CYHS2600383 Generic2026/02/05Not stated by sourceCDE
API registrations

Non-component matches: 7 companies with A status and 4 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
头孢托仑匹酯河南康达制药有限公司Y20260000465IExact ingredient2026/06/24CDE
头孢托仑匹酯广东立国制药有限公司Y20250001428IExact ingredient2026/01/15CDE
头孢托仑匹酯四川仁安药业有限责任公司Y20250000584IExact ingredient2025/10/27CDE
头孢托仑匹酯浙江普洛得邦制药有限公司Y20250000349AExact ingredient2026/09/01CDE
头孢托仑匹酯苏州盛达药业有限公司Y20240000558AExact ingredient2026/04/01CDE
头孢托仑匹酯华北制药河北华民药业有限责任公司Y20240000528AExact ingredient2026/02/26CDE
头孢托仑匹酯Yungjin Pharm. Co., Ltd.Y20230001217IExact ingredient2025/11/11CDE
头孢托仑匹酯浙江东邦药业有限公司Y20240000215AExact ingredient2025/11/03CDE
头孢托仑匹酯福安药业集团重庆博圣制药有限公司Y20230000157AExact ingredient2025/10/12CDE
头孢托仑匹酯齐鲁安替制药有限公司Y20220000789AExact ingredient2024/10/14CDE
头孢托仑匹酯浙江华方药业股份有限公司Y20190004767AExact ingredient—CDE
头孢托仑匹酯齐鲁安替制药有限公司Y20170000963AExact ingredient2023/12/06CDE

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. 2026/10/28Notification delivery

    湖北凯安晨医药科技有限公司

    CYHS2503794

    Fact date: 2026/10/28 (Publication date) · Publication date: 2026/10/28 · Site observation date: 2026/11/03

    Notification delivered; the specific outcome remains to be checked.

    View source · Table row 13 ↗

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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