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注射用头孢呋辛钠/氯化钠注射液

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

Last 90 days: Accepted: 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; 1 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
北京锐业制药有限公司北京锐业制药有限公司 国药准字H20217060 2023/08/29 粉体室:1.5g(按C16H16N4O8S计);液体室:100ml∶氯化钠0.9g Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) CDE
北京锐业制药有限公司北京锐业制药有限公司 国药准字H20193161 2023/08/29 粉体室:0.75g(按C16H16N4O8S计);液体室:100ml:氯化钠0.9g Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) CDE
湖南科伦制药有限公司湖南科伦制药有限公司 国药准字H20234034 2023/08/08 粉体室:0.75g(按C16H16N4O8S计);液体室:100ml∶0.9g 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
湖南科伦制药有限公司湖南科伦制药有限公司 国药准字H20234035 2023/08/08 粉体室:1.5g(按C16H16N4O8S计);液体室:100ml∶0.9g 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: 4 distinct approval numbers and 2 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
北京锐业制药有限公司 国药准字H20193161 粉体室:0.75g(按C₁₆H₁₆N₄O₈S计);液体室:100ml: Category B (乙) XJ01DCT187B002010100108NHSA
湖南科伦制药有限公司 国药准字H20234034 粉体室:0.75g(按C₁₆H₁₆N₄O₈S计);液体 Category B (乙) XJ01DCT187B002010104948NHSA
北京锐业制药有限公司 国药准字H20193161 粉体室:0.75g(按C₁₆H₁₆N₄O₈S计);液体室:100ml: Category B (乙) XJ01DCT187B002010200108NHSA
湖南科伦制药有限公司 国药准字H20234034 粉体室:0.75g(按C₁₆H₁₆N₄O₈S计);液体 Category B (乙) XJ01DCT187B002010204948NHSA
湖南科伦制药有限公司 国药准字H20234034 粉体室:0.75g(按C₁₆H₁₆N₄O₈S计);液体 Category B (乙) XJ01DCT187B002010304948NHSA
北京锐业制药有限公司 国药准字H20217060 粉体室:1.5g(按C₁₆H₁₆N₄O₈S计);液体室:100ml: Category B (乙) XJ01DCT187B002020100108NHSA
湖南科伦制药有限公司 国药准字H20234035 粉体室:1.5g(按C₁₆H₁₆N₄O₈S计);液体 Category B (乙) XJ01DCT187B002020104948NHSA
北京锐业制药有限公司 国药准字H20217060 粉体室:1.5g(按C₁₆H₁₆N₄O₈S计);液体室:100ml: Category B (乙) XJ01DCT187B002020200108NHSA
湖南科伦制药有限公司 国药准字H20234035 粉体室:1.5g(按C₁₆H₁₆N₄O₈S计);液体 Category B (乙) XJ01DCT187B002020204948NHSA
湖南科伦制药有限公司 国药准字H20234035 粉体室:1.5g(按C₁₆H₁₆N₄O₈S计);液体 Category B (乙) XJ01DCT187B002020304948NHSA

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: 5 filings and 3 distinct first applicants.

Generic 3 · Supplement 2

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
海南倍特药业有限公司 CYHS2601970 Generic2026/08/11Not stated by sourceCDE
海南倍特药业有限公司 CYHS2600710 Generic2026/03/24Not stated by sourceCDE
北京锐业制药有限公司;北京锐业制药(潜山)有限公司 CYHB2600397 Supplement2026/02/26Not stated by sourceCDE
北京锐业制药有限公司;北京锐业制药(潜山)有限公司 CYHB2600396 Supplement2026/02/26Not stated by sourceCDE
石家庄四药有限公司;湖南科伦制药有限公司 CYHS2602720 Generic2026/11/05Not stated by sourceCDE
New generic filings in 2026

Loaded records: 3 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
海南倍特药业有限公司 CYHS2601970 Generic2026/08/11Not stated by sourceCDE
海南倍特药业有限公司 CYHS2600710 Generic2026/03/24Not stated by sourceCDE
石家庄四药有限公司;湖南科伦制药有限公司 CYHS2602720 Generic2026/11/05Not stated by sourceCDE
API registrations

Non-component matches: 0 companies with A status and 0 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
No matching records were found in the currently loaded source data; coverage dates are listed below.

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. 2026/11/05Accepted

    石家庄四药有限公司;湖南科伦制药有限公司

    CYHS2602720

    Fact date: 2026/11/05 · Site observation date: 2026/11/06

    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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