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复方氨基酸注射液(18AA-VII)

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

Last 90 days: Marketing application approved: 1 applicationAccepted: 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: 9 holders; 3 in the quality-and-efficacy consistency-evaluation category, and 5 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
四川太平洋药业有限责任公司四川太平洋药业有限责任公司 国药准字H20255677 2025/10/14 200ml:20.650g(按总氨基酸计) 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
华夏生生药业(北京)有限公司华夏生生药业(北京)有限公司 国药准字H20254959 2025/07/29 200ml﹕20.650g(按总氨基酸计) 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
山东齐都药业有限公司山东齐都药业有限公司 国药准字H20253761 2025/04/01 200ml:20.650g(按总氨基酸计) 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
四川科伦药业股份有限公司四川科伦药业股份有限公司 国药准字H20243589 2024/04/24 200ml:20.650g(总氨基酸) 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
安徽富邦药业有限公司安徽富邦药业有限公司 国药准字H20123185 2023/09/25 200ml:20.650g(按总氨基酸计) Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) CDE
沈阳海思科制药有限公司辽宁海思科制药有限公司 国药准字H20173023 2023/06/08 400ml:41.300g(按总氨基酸计) Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) CDE
辽宁海思科制药有限公司辽宁海思科制药有限公司 国药准字H20103264 2021/07/14 200ml:20.650g(按总氨基酸计) Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) CDE
—广州绿十字制药有限公司 国药准字H20020157 2002/05/08 200ml:20.650g(总氨基酸) Other drug (其他药品) CDE
湖北津药药业股份有限公司湖北津药药业股份有限公司 国药准字H20266024 2026/09/15 200ml﹕20.650g(按总氨基酸计) 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: 10 distinct approval numbers and 9 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
辽宁海思科制药有限公司 国药准字H20173023 400ml:41.300g(按总氨基酸计) Category B (乙) XB05BAF155B002020106155NHSA
广州绿十字制药股份有限公司 国药准字H20020157 200ml∶20.650g(总氨基酸) Category B (乙) XB05BAF155B002010100475NHSA
湖北津药药业股份有限公司 国药准字H20266024 200ml:20.650g(按总氨基酸计) Category B (乙) XB05BAF155B002010101866NHSA
四川科伦药业股份有限公司 国药准字H20243589 200ml:20.650g(总氨基酸) Category B (乙) XB05BAF155B002010102180NHSA
四川太平洋药业有限责任公司 国药准字H20255677 200ml:20.650g(按总氨基酸计) Category B (乙) XB05BAF155B002010102261NHSA
内蒙古白医制药股份有限公司 国药准字H20253421 200ml:20.650g(按总氨基酸计) Category B (乙) XB05BAF155B002010103889NHSA
山东齐都药业有限公司 国药准字H20253761 200ml:20.650g(按总氨基酸计) Category B (乙) XB05BAF155B002010104145NHSA
辽宁海思科制药有限公司 国药准字H20103264 200ml:20.650g(按总氨基酸计) Category B (乙) XB05BAF155B002010106155NHSA
安徽富邦药业有限公司 国药准字H20123185 200ml:20.650g(总氨基酸) Category B (乙) XB05BAF155B002010109617NHSA
华夏生生药业(北京)有限公司 国药准字H20254959 200ml:20.650g(按总氨基酸计) Category B (乙) XB05BAF155B002010109910NHSA
广州绿十字制药股份有限公司 国药准字H20020157 200ml∶20.650g(总氨基酸) Category B (乙) XB05BAF155B002010200475NHSA
四川科伦药业股份有限公司 国药准字H20243589 200ml:20.650g(总氨基酸) Category B (乙) XB05BAF155B002010202180NHSA
山东齐都药业有限公司 国药准字H20253761 200ml:20.650g(按总氨基酸计) Category B (乙) XB05BAF155B002010204145NHSA
辽宁海思科制药有限公司 国药准字H20103264 200ml:20.650g(按总氨基酸计) Category B (乙) XB05BAF155B002010206155NHSA
四川科伦药业股份有限公司 国药准字H20243589 200ml:20.650g(总氨基酸) Category B (乙) XB05BAF155B002010302180NHSA
安徽富邦药业有限公司 国药准字H20123185 200ml:20.650g(总氨基酸) Category B (乙) XB05BAF155B002020109617NHSA

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 4 distinct first applicants.

Generic 5

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
湖北长联杜勒制药有限公司 CYHS2600713 Generic2026/03/25Not stated by sourceCDE
湖北一半天制药有限公司 CYHS2600491 Generic2026/02/14Not stated by sourceCDE
湖北一半天制药有限公司 CYHS2600490 Generic2026/02/14Not stated by sourceCDE
山东豪瑞恩制药有限公司;广州绿十字制药股份有限公司 CYHS2602514 Generic2026/10/13Not stated by sourceCDE
武汉市小铂生物科技有限公司;湖北长联杜勒制药有限公司 CYHS2503772 Generic2025/10/23Not stated by sourceCDE
New generic filings in 2026

Loaded records: 4 filings and 3 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
湖北长联杜勒制药有限公司 CYHS2600713 Generic2026/03/25Not stated by sourceCDE
湖北一半天制药有限公司 CYHS2600491 Generic2026/02/14Not stated by sourceCDE
湖北一半天制药有限公司 CYHS2600490 Generic2026/02/14Not stated by sourceCDE
山东豪瑞恩制药有限公司;广州绿十字制药股份有限公司 CYHS2602514 Generic2026/10/13Not 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. 2026/10/26Marketing application approved

    辰欣药业股份有限公司

    CYHS2502233 · 国药准字H20266422

    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 51 ↗
  2. 2026/10/13Accepted

    山东豪瑞恩制药有限公司;广州绿十字制药股份有限公司

    CYHS2602514

    Fact date: 2026/10/13 · 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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