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Potassium Sodium Hydrogen Citrate Granules(枸橼酸氢钾钠颗粒)

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

Last 90 days: Accepted: 3 applicationsSupplement 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: 10 holders; 1 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
成都恒瑞制药有限公司成都恒瑞制药有限公司 国药准字H20264066 2026/04/21 97.1g/100g 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
浙江赛默制药有限公司浙江赛默制药有限公司 国药准字H20255246 2025/08/26 2.5g:2.4275g 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
浙江沣华医药科技有限公司浙江赛默制药有限公司 国药准字H20255249 2025/08/26 2.5g:2.4275g 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
湖北午时医药研究院有限公司湖北午时药业股份有限公司 国药准字H20249054 2024/10/16 2.5g:2.4275g 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
四川省通园制药集团有限公司四川省通园制药集团有限公司 国药准字H20244175 2024/06/28 2.5g:2.4275g 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
武汉维奥制药有限公司武汉维奥制药有限公司 国药准字H20103086 2021/12/20 2.5g:2.4275g Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) CDE
沈阳华泰药物研究有限公司沈阳福宁药业有限公司 国药准字H20213268 2021/04/13 97.1g/100g 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
浙江施强制药有限公司浙江施强制药有限公司 国药准字H20203639 2020/12/02 2.5g:2.4275g 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
湖南九典制药股份有限公司湖南九典制药股份有限公司 国药准字H20203503 2020/09/30 2.5g:2.4275 g 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
Meda Pharma GmbH & Co. KGPlantextrakt GmbH & Co.KG H20181127;H20181128 1993/03/09 97.1g/100g 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: 10 distinct approval numbers and 10 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
沈阳华泰药物研究有限公司 国药准字H20213268 97.1g/100g Not stated by sourceXG04BXJ228N001010101287NHSA
武汉维奥制药有限公司 国药准字H20103086 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010101975NHSA
四川省通园制药集团有限公司 国药准字H20244175 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010102237NHSA
浙江施强制药有限公司 国药准字H20203639 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010104578NHSA
湖南九典制药股份有限公司 国药准字H20203503 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010104942NHSA
Viatris Healthcare GmbH 国药准字HJ20181128 97.1g/100g Not stated by sourceXG04BXJ228N001010178626NHSA
浙江赛默制药有限公司 国药准字H20255246 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010183549NHSA
浙江众延医药科技有限公司 国药准字H20253440 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010184225NHSA
浙江沣华医药科技有限公司 国药准字H20255249 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010184235NHSA
湖北午时医药研究院有限公司 国药准字H20249054 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010184568NHSA
武汉维奥制药有限公司 国药准字H20103086 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010201975NHSA
四川省通园制药集团有限公司 国药准字H20244175 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010202237NHSA
湖南九典制药股份有限公司 国药准字H20203503 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010204942NHSA
浙江赛默制药有限公司 国药准字H20255246 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010283549NHSA
浙江众延医药科技有限公司 国药准字H20253440 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010284225NHSA
浙江沣华医药科技有限公司 国药准字H20255249 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010284235NHSA
武汉维奥制药有限公司 国药准字H20103086 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010301975NHSA
湖南九典制药股份有限公司 国药准字H20203503 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010304942NHSA
浙江赛默制药有限公司 国药准字H20255246 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010383549NHSA
浙江众延医药科技有限公司 国药准字H20253440 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010384225NHSA
浙江沣华医药科技有限公司 国药准字H20255249 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010384235NHSA
湖南九典制药股份有限公司 国药准字H20203503 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010404942NHSA
浙江众延医药科技有限公司 国药准字H20253440 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010484225NHSA
浙江沣华医药科技有限公司 国药准字H20255249 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010484235NHSA
浙江众延医药科技有限公司 国药准字H20253440 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010584225NHSA
浙江众延医药科技有限公司 国药准字H20253440 2.5g:2.4275g Not stated by sourceXG04BXJ228N001010684225NHSA

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: 8 filings and 7 distinct first applicants.

Import re-registration 2 · Generic 5 · Supplement 1

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Viatris Healthcare GmbH;Martin Bauer GmbH & Co. KG JYHZ2600206 Import re-registration2026/08/27Not stated by sourceCDE
Viatris Healthcare GmbH;Martin Bauer GmbH & Co. KG JYHZ2600205 Import re-registration2026/08/27Not stated by sourceCDE
许昌恒生制药有限公司 CYHS2601841 Generic2026/07/30Not stated by sourceCDE
上海金不换兰考制药有限公司 CYHS2601166 Generic2026/05/18Not stated by sourceCDE
沈阳欣瑞制药有限公司 CYHS2600925 Generic2026/04/23Not stated by sourceCDE
成都克莱蒙医药科技有限公司;成都倍特得诺药业有限公司 CYHS2600714 Generic2026/03/25Not stated by sourceCDE
国药集团国瑞药业有限公司 CYHS2600645 Generic2026/03/11Not stated by sourceCDE
湖南九典制药股份有限公司 CYHB2600363 Supplement2026/02/14Not stated by sourceCDE
New generic filings in 2026

Loaded records: 5 filings and 5 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
许昌恒生制药有限公司 CYHS2601841 Generic2026/07/30Not stated by sourceCDE
上海金不换兰考制药有限公司 CYHS2601166 Generic2026/05/18Not stated by sourceCDE
沈阳欣瑞制药有限公司 CYHS2600925 Generic2026/04/23Not stated by sourceCDE
成都克莱蒙医药科技有限公司;成都倍特得诺药业有限公司 CYHS2600714 Generic2026/03/25Not stated by sourceCDE
国药集团国瑞药业有限公司 CYHS2600645 Generic2026/03/11Not 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. 2026/10/16Supplement delivery

    四川恒瑞制药有限公司

    CYHB2601796

    Fact date: 2026/10/16 · Publication date: 2026/10/19 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 21 ↗
  2. 2026/09/22Accepted

    四川恒瑞制药有限公司;成都恒瑞制药有限公司

    CYHB2601796

    Fact date: 2026/09/22 · Site observation date: 2026/10/22

    View source ↗
  3. 2026/08/27Accepted

    Viatris Healthcare GmbH;Martin Bauer GmbH & Co. KG

    JYHZ2600206

    Fact date: 2026/08/27 · Site observation date: 2026/10/22

    View source ↗
  4. 2026/08/27Accepted

    Viatris Healthcare GmbH;Martin Bauer GmbH & Co. KG

    JYHZ2600205

    Fact date: 2026/08/27 · 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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