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Vancomycin Hydrochloride for Injection(注射用盐酸万古霉素)

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

Last 90 days: No longer listed under review: 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: 12 holders; 3 in the quality-and-efficacy consistency-evaluation category, and 8 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
福安药业集团湖北人民制药有限公司福安药业集团湖北人民制药有限公司 国药准字H20265043 2026/06/30 0.5g(50万单位)(按C66H75Cl2N9O24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
安徽省先锋制药有限公司安徽省先锋制药有限公司 国药准字H20264232 2026/05/07 0.5g(50万单位)(按C66H75Cl2N9O24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
华北制药股份有限公司华北制药股份有限公司 国药准字H20255230 2025/08/26 0.5g(50万单位)(按C66H75Cl2N9O24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
海南倍特药业有限公司海南倍特药业有限公司 国药准字H20253781 2025/04/01 0.5g(50万单位)(按C66H75Cl2N9O24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
山东鲁抗医药股份有限公司成都通德药业有限公司 国药准字H20244955 2024/09/19 0.5g(50万单位)(按C66H75Cl2N9O24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
南京恒道医药科技股份有限公司江苏九旭药业有限公司 国药准字H20244808 2024/09/03 0.5g(50万单位)(按C66H75Cl2N9O24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
海南普利制药股份有限公司海南普利制药股份有限公司 国药准字H20243660 2024/05/08 0.5g(50万单位)(按C66H75Cl2N9O24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
丽珠集团丽珠制药厂丽珠集团丽珠制药厂 国药准字H20193378 2023/04/05 0.5g(50万单位)(按C66H75Cl2N9O24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
浙江海正药业股份有限公司浙江海正药业股份有限公司 国药准字H20084268 2021/11/15 0.5g(50万单位)(按C66H75Cl2N9O24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
浙江医药股份有限公司浙江医药股份有限公司新昌制药厂 国药准字H20033366 2021/06/03 0.5g(50万单位)(按C66H75Cl2N9O24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
VANCOCIN ITALIA S.R.L.VIANEX S.A.(PLANT C) H20140174 1988/10/15 500mg Imported originator drug (进口原研药品) CDE
重庆药友制药有限责任公司重庆药友制药有限责任公司 国药准字H20254904 2025/07/22 0.5g(50万单位)(按C66H75Cl2N9O24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: 15 distinct approval numbers and 14 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
丽珠集团丽珠制药厂 国药准字H20193378 0.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) Category B (乙) XJ01XAW001B001010100453NHSA
重庆药友制药有限责任公司 国药准字H20254904 0.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) Category B (乙) XJ01XAW001B001010101066NHSA
华北制药股份有限公司 国药准字H20255230 0.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) Category B (乙) XJ01XAW001B001010102690NHSA
安徽省先锋制药有限公司 国药准字H20264232 0.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) Category B (乙) XJ01XAW001B001010104339NHSA
浙江海正药业股份有限公司 国药准字H20084268 0.5g(50万单位)(按C66H75Cl2N9O24计) Category B (乙) XJ01XAW001B001010104641NHSA
浙江医药股份有限公司新昌制药厂 国药准字H20033366 0.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) Category B (乙) XJ01XAW001B001010104747NHSA
海南倍特药业有限公司 国药准字H20253781 0.5g(50万单位)(按C66H75Cl2N9O24计) Category B (乙) XJ01XAW001B001010105791NHSA
海南普利制药股份有限公司 国药准字H20243660 0.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) Category B (乙) XJ01XAW001B001010105801NHSA
福安药业集团湖北人民制药有限公司 国药准字H20265043 0.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) Category B (乙) XJ01XAW001B001010109554NHSA
VANCOCIN ITALIA S.R.L. 国药准字HJ20140174 0.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) Category B (乙) XJ01XAW001B001010178400NHSA
CJ HealthCare Corporation H20171132 0.5g(相当于万古霉素50万单位) Category B (乙) XJ01XAW001B001010179134NHSA
Gentle pharma Co.,Ltd. HC20150054 0.5g(按万古霉素计) Category B (乙) XJ01XAW001B001010179360NHSA
南京恒道医药科技股份有限公司 国药准字H20244808 0.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) Category B (乙) XJ01XAW001B001010183035NHSA
山东鲁抗医药股份有限公司 国药准字H20244955 0.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) Category B (乙) XJ01XAW001B001010183198NHSA
丽珠集团丽珠制药厂 国药准字H20193378 0.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) Category B (乙) XJ01XAW001B001010200453NHSA
安徽省先锋制药有限公司 国药准字H20264232 0.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) Category B (乙) XJ01XAW001B001010204339NHSA
浙江海正药业股份有限公司 国药准字H20084268 0.5g(50万单位)(按C66H75Cl2N9O24计) Category B (乙) XJ01XAW001B001010204641NHSA
海南倍特药业有限公司 国药准字H20253781 0.5g(50万单位)(按C66H75Cl2N9O24计) Category B (乙) XJ01XAW001B001010205791NHSA
海南普利制药股份有限公司 国药准字H20243660 0.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) Category B (乙) XJ01XAW001B001010205801NHSA
福安药业集团湖北人民制药有限公司 国药准字H20265043 0.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) Category B (乙) XJ01XAW001B001010209554NHSA
Gentle pharma Co.,Ltd. HC20150054 0.5g(按万古霉素计) Category B (乙) XJ01XAW001B001010279360NHSA
南京恒道医药科技股份有限公司 国药准字H20244808 0.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) Category B (乙) XJ01XAW001B001010283035NHSA
南京恒道医药科技股份有限公司 国药准字H20244808 0.5g(50万单位)(按C₆₆H₇₅Cl₂N₉O₂₄计) Category B (乙) XJ01XAW001B001010383035NHSA
浙江海正药业股份有限公司 国药准字H20084269 按C66H75Cl2N9O24计1.0g(100万单位) Category B (乙) XJ01XAW001B001020104641NHSA
浙江海正药业股份有限公司 国药准字H20084269 按C66H75Cl2N9O24计1.0g(100万单位) Category B (乙) XJ01XAW001B001020204641NHSA

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: 4 filings and 4 distinct first applicants.

Generic 4

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
南京海纳制药有限公司 CYHS2600957 Generic2026/04/24Not stated by sourceCDE
亿腾医药(珠海)有限公司;南京健友生化制药股份有限公司 CYHS2600726 Generic2026/03/26Not stated by sourceCDE
深圳立健药业有限公司 CYHS2601766 Generic2026/07/23Not stated by sourceCDE
石家庄四药有限公司 CYHS2600636 Generic2026/03/10Not stated by sourceCDE
New generic filings in 2026

Loaded records: 4 filings and 4 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
南京海纳制药有限公司 CYHS2600957 Generic2026/04/24Not stated by sourceCDE
亿腾医药(珠海)有限公司;南京健友生化制药股份有限公司 CYHS2600726 Generic2026/03/26Not stated by sourceCDE
深圳立健药业有限公司 CYHS2601766 Generic2026/07/23Not stated by sourceCDE
石家庄四药有限公司 CYHS2600636 Generic2026/03/10Not stated by sourceCDE
API registrations

Non-component matches: 6 companies with A status and 5 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
万古霉素雅赛利(台州)制药有限公司Y20260000210ISalt-normalized ingredient2026/04/20CDE
盐酸万古霉素浙江昌海制药有限公司Y20240000397IExact ingredient2024/04/22CDE
盐酸万古霉素北大医药重庆大新药业股份有限公司Y20230000840IExact ingredient2023/10/19CDE
盐酸万古霉素浙江昌海制药有限公司Y20230000281AExact ingredient2025/03/06CDE
盐酸万古霉素北大医药重庆大新药业股份有限公司Y20210000777IExact ingredient2024/11/12CDE
盐酸万古霉素核芯医药(山东)有限公司Y20190000434IExact ingredient2020/06/03CDE
盐酸万古霉素浙江医药股份有限公司新昌制药厂Y20190009487AExact ingredient—CDE
盐酸万古霉素华北制药华胜有限公司Y20190006976AExact ingredient—CDE
盐酸万古霉素浙江海正药业股份有限公司Y20190006263AExact ingredient2025/07/04CDE
盐酸万古霉素浙江医药股份有限公司新昌制药厂Y20180001287AExact ingredient2025/03/18CDE
盐酸万古霉素丽珠集团福州福兴医药有限公司Y20170000276AExact ingredient2026/09/03CDE
盐酸万古霉素雅赛利(台州)制药有限公司Y20170000173AExact ingredient2024/10/22CDE

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. 2026/11/06No longer listed under review

    湖北美林药业有限公司

    CYHS2501535

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

    Accepted: 2025/04/23

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    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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