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Cefcapene Pivoxil Hydrochloride Granules(盐酸头孢卡品酯颗粒)

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 2 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Yungjin Pharm. Co., Ltd.Yungjin Pharm. Co., Ltd. 国药准字HJ20260045 2026/04/21 50mg(按 C17H19N5O6S2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
苏州盛达药业有限公司苏州第三制药厂有限责任公司 国药准字H20263866 2026/04/07 50mg(按 C17H19N5O6S2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: 3 distinct approval numbers and 3 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
苏州盛达药业有限公司 国药准字H20263866 50mg(按 C₁₇H₁₉N₅O₆S₂计) Category B (乙) XJ01DDT197N001010101680NHSA
SHIONOGI & Co., LTD. 国药准字HJ20210072 50mg (按C₁₇H₁₉N₅O₆S₂计) Category B (乙) XJ01DDT197N001010179170NHSA
Yungjin Pharm. Co., Ltd. 国药准字HJ20260045 50mg(按C₁₇H₁₉N₅O₆S₂计) Category B (乙) XJ01DDT197N001010185540NHSA
苏州盛达药业有限公司 国药准字H20263866 50mg(按 C₁₇H₁₉N₅O₆S₂计) Category B (乙) XJ01DDT197N001010201680NHSA
SHIONOGI & Co., LTD. 国药准字HJ20210072 50mg (按C₁₇H₁₉N₅O₆S₂计) Category B (乙) XJ01DDT197N001010279170NHSA
Yungjin Pharm. Co., Ltd. 国药准字HJ20260045 50mg(按C₁₇H₁₉N₅O₆S₂计) Category B (乙) XJ01DDT197N001010285540NHSA
苏州盛达药业有限公司 国药准字H20263866 50mg(按 C₁₇H₁₉N₅O₆S₂计) Category B (乙) XJ01DDT197N001010301680NHSA
SHIONOGI & Co., LTD. 国药准字HJ20210072 50mg (按C₁₇H₁₉N₅O₆S₂计) Category B (乙) XJ01DDT197N001010379170NHSA
Yungjin Pharm. Co., Ltd. 国药准字HJ20260045 50mg(按C₁₇H₁₉N₅O₆S₂计) Category B (乙) XJ01DDT197N001010385540NHSA
苏州盛达药业有限公司 国药准字H20263866 50mg(按 C₁₇H₁₉N₅O₆S₂计) Category B (乙) XJ01DDT197N001010401680NHSA
苏州盛达药业有限公司 国药准字H20263866 50mg(按 C₁₇H₁₉N₅O₆S₂计) Category B (乙) XJ01DDT197N001010501680NHSA

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: 11 filings and 11 distinct first applicants.

Generic 10 · Supplement 1

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
湖南科伦制药有限公司 CYHS2600965 Generic2026/04/25Not stated by sourceCDE
苏州二叶制药有限公司;苏州第三制药厂有限责任公司 CYHS2600738 Generic2026/03/28Not stated by sourceCDE
石药集团中诺药业(石家庄)有限公司 CYHS2601190 Generic2026/05/21Not stated by sourceCDE
福安药业集团庆余堂制药有限公司 CYHS2601116 Generic2026/05/14Not stated by sourceCDE
哈药集团制药总厂;金鸿药业股份有限公司 CYHS2600653 Generic2026/03/13Not stated by sourceCDE
湖北凯安晨医药科技有限公司;金鸿药业股份有限公司 CYHS2600287 Generic2026/01/27Not stated by sourceCDE
广州艾奇西医药科技有限公司;金鸿药业股份有限公司 CYHS2600208 Generic2026/01/17Not stated by sourceCDE
成都倍特药业股份有限公司 CYHS2503751 Generic2025/10/21Not stated by sourceCDE
杭州和泽坤元药业有限公司;山西同达药业有限公司 CYHS2503617 Generic2025/10/10Not stated by sourceCDE
海南广升誉制药有限公司;金鸿药业股份有限公司 CYHS2502391 Generic2025/07/05Not stated by sourceCDE
SHIONOGI & Co. LTD.;Shionogi Pharma Co. Ltd. Kanegasaki Plant JYHB2500240 Supplement2025/04/28Not stated by sourceCDE
New generic filings in 2026

Loaded records: 7 filings and 7 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
湖南科伦制药有限公司 CYHS2600965 Generic2026/04/25Not stated by sourceCDE
苏州二叶制药有限公司;苏州第三制药厂有限责任公司 CYHS2600738 Generic2026/03/28Not stated by sourceCDE
石药集团中诺药业(石家庄)有限公司 CYHS2601190 Generic2026/05/21Not stated by sourceCDE
福安药业集团庆余堂制药有限公司 CYHS2601116 Generic2026/05/14Not stated by sourceCDE
哈药集团制药总厂;金鸿药业股份有限公司 CYHS2600653 Generic2026/03/13Not stated by sourceCDE
湖北凯安晨医药科技有限公司;金鸿药业股份有限公司 CYHS2600287 Generic2026/01/27Not stated by sourceCDE
广州艾奇西医药科技有限公司;金鸿药业股份有限公司 CYHS2600208 Generic2026/01/17Not 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
盐酸头孢卡品酯福建省福抗药业股份有限公司Y20260000084IExact ingredient2026/04/17CDE
盐酸头孢卡品酯河南康达制药有限公司Y20260000005IExact ingredient2026/02/02CDE
盐酸头孢卡品酯四川仁安药业有限责任公司Y20250000713IExact ingredient2025/07/21CDE
盐酸头孢卡品酯浙江东邦药业有限公司Y20250000411IExact ingredient2025/06/13CDE
盐酸头孢卡品酯齐鲁安替制药有限公司Y20250000396IExact ingredient2025/05/21CDE
盐酸头孢卡品酯苏州盛达药业有限公司Y20240000559AExact ingredient2026/02/05CDE
盐酸头孢卡品酯Yungjin Pharm. Co., Ltd.Y20230001064AExact ingredient2026/10/24CDE
盐酸头孢卡品酯四川仁安药业有限责任公司Y20230001119AExact ingredient2025/10/14CDE
盐酸头孢卡品酯湖北凌晟药业股份有限公司Y20230000800AExact ingredient2025/02/24CDE
盐酸头孢卡品酯Yungjin Pharm. Co., LtdY20210000721IExact ingredient2021/09/07CDE
盐酸头孢卡品酯江苏豪森药业集团有限公司Y20190003529AExact ingredient2025/05/21CDE
盐酸头孢卡品酯石药信汇(天津)医药科技有限公司Y20190002831AExact ingredient—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.

  1. 2026/11/04Notification delivery

    沐源(安徽)药业有限公司

    CYHS2504185

    Fact date: 2026/11/04 (Publication date) · Publication date: 2026/11/04 · Site observation date: 2026/11/04

    Notification delivered; the specific outcome remains to be checked.

    View source · Table row 12 ↗

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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