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Rupatadine Fumarate Tablets

As of 13 November 2026, for Rupatadine Fumarate Tablets, 2 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 11 holders.

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

Last 90 days: Accepted: 1 application

Current coverage may be incomplete

Follow for free
Complete CDE snapshot
2026/11/13 06:42
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.

Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.

Chemical-drug catalogue

Loaded records: 11 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
Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanizedZhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H202546502025/06/24See sourceGeneric approved under the new chemical-drug registration classificationCDE
Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedAnhui Tai En Kang Pharmaceutical Co., Ltd. romanized国药准字H202533302025/01/24See sourceGeneric approved under the new chemical-drug registration classificationCDE
Beijing Foyou Pharma CO.,LTDBeijing Foyou Pharma CO.,LTD国药准字H202494372024/11/22See sourceGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Pu Li Pharma Co., Ltd. romanizedZhejiang Pu Li Pharma Co., Ltd. romanized国药准字H202491632024/10/22See sourceGeneric approved under the new chemical-drug registration classificationCDE
Rui Yang Pharmaceutical Co., Ltd. romanizedRui Yang Pharmaceutical Co., Ltd. romanized国药准字H202447132024/08/20See sourceGeneric approved under the new chemical-drug registration classificationCDE
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.国药准字H202445312024/07/30See sourceGeneric approved under the new chemical-drug registration classificationCDE
Name not romanizedJiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H202436972024/05/15See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hefei En Rui Te Pharma Co., Ltd. romanizedHefei En Rui Te Pharma Co., Ltd. romanized国药准字H202430532024/01/16See sourceGeneric approved under the new chemical-drug registration classificationCDE
Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanizedBeijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H201400972023/09/26See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Hai Si Ke Pharmaceuticals Group Co., Ltd. romanizedHai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized国药准字H201400262023/07/25See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanizedYang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized国药准字H201731122022/11/10See sourceDrug that passed quality-and-efficacy consistency evaluationCDE

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: 12 distinct approval numbers and 12 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H20140097See sourceNot stated by sourceXR06AXL339A001010100151NHSA
Beijing Foyou Pharma CO.,LTD国药准字H20249437See sourceNot stated by sourceXR06AXL339A001010100177NHSA
Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized国药准字H20173112See sourceNot stated by sourceXR06AXL339A001010101749NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20244713See sourceNot stated by sourceXR06AXL339A001010104152NHSA
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.国药准字H20244531See sourceNot stated by sourceXR06AXL339A001010104647NHSA
Hefei En Rui Te Pharma Co., Ltd. romanized国药准字H20243053See sourceNot stated by sourceXR06AXL339A001010110237NHSA
Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized国药准字H20140026See sourceNot stated by sourceXR06AXL339A001010179282NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized国药准字H20249163See sourceNot stated by sourceXR06AXL339A001010182922NHSA
Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized国药准字H20253330See sourceNot stated by sourceXR06AXL339A001010183034NHSA
Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H20254650See sourceNot stated by sourceXR06AXL339A001010183549NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20243697See sourceNot stated by sourceXR06AXL339A001010184643NHSA
Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H20140097See sourceNot stated by sourceXR06AXL339A001010200151NHSA
Beijing Foyou Pharma CO.,LTD国药准字H20249437See sourceNot stated by sourceXR06AXL339A001010200177NHSA
Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized国药准字H20173112See sourceNot stated by sourceXR06AXL339A001010201749NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20244713See sourceNot stated by sourceXR06AXL339A001010204152NHSA
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.国药准字H20244531See sourceNot stated by sourceXR06AXL339A001010204647NHSA
Hefei En Rui Te Pharma Co., Ltd. romanized国药准字H20243053See sourceNot stated by sourceXR06AXL339A001010210237NHSA
Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized国药准字H20140026See sourceNot stated by sourceXR06AXL339A001010279282NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized国药准字H20249163See sourceNot stated by sourceXR06AXL339A001010282922NHSA
Noucor Health S.A.国药准字HJ20200036See sourceNot stated by sourceXR06AXL339A001010283044NHSA
Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H20254650See sourceNot stated by sourceXR06AXL339A001010283549NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20243697See sourceNot stated by sourceXR06AXL339A001010284643NHSA
Beijing Foyou Pharma CO.,LTD国药准字H20249437See sourceNot stated by sourceXR06AXL339A001010300177NHSA
Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized国药准字H20173112See sourceNot stated by sourceXR06AXL339A001010301749NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20244713See sourceNot stated by sourceXR06AXL339A001010304152NHSA
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.国药准字H20244531See sourceNot stated by sourceXR06AXL339A001010304647NHSA
Hefei En Rui Te Pharma Co., Ltd. romanized国药准字H20243053See sourceNot stated by sourceXR06AXL339A001010310237NHSA
Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized国药准字H20140026See sourceNot stated by sourceXR06AXL339A001010379282NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized国药准字H20249163See sourceNot stated by sourceXR06AXL339A001010382922NHSA
Noucor Health S.A.国药准字HJ20200036See sourceNot stated by sourceXR06AXL339A001010383044NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20243697See sourceNot stated by sourceXR06AXL339A001010384643NHSA
Beijing Foyou Pharma CO.,LTD国药准字H20249437See sourceNot stated by sourceXR06AXL339A001010400177NHSA
Rui Yang Pharmaceutical Co., Ltd. romanized国药准字H20244713See sourceNot stated by sourceXR06AXL339A001010404152NHSA
Hefei En Rui Te Pharma Co., Ltd. romanized国药准字H20243053See sourceNot stated by sourceXR06AXL339A001010410237NHSA
Noucor Health S.A.国药准字HJ20200036See sourceNot stated by sourceXR06AXL339A001010483044NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20243697See sourceNot stated by sourceXR06AXL339A001010484643NHSA
Beijing Foyou Pharma CO.,LTD国药准字H20249437See sourceNot stated by sourceXR06AXL339A001010500177NHSA
Hefei En Rui Te Pharma Co., Ltd. romanized国药准字H20243053See sourceNot stated by sourceXR06AXL339A001010510237NHSA
Noucor Health S.A.国药准字HJ20200036See sourceNot stated by sourceXR06AXL339A001010583044NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20243697See sourceNot stated by sourceXR06AXL339A001010584643NHSA
Hefei En Rui Te Pharma Co., Ltd. romanized国药准字H20243053See sourceNot stated by sourceXR06AXL339A001010610237NHSA
Noucor Health S.A.国药准字HJ20200036See sourceNot stated by sourceXR06AXL339A001010683044NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20243697See sourceNot stated by sourceXR06AXL339A001010684643NHSA
Hefei En Rui Te Pharma Co., Ltd. romanized国药准字H20243053See sourceNot stated by sourceXR06AXL339A001010710237NHSA
Noucor Health S.A.国药准字HJ20200036See sourceNot stated by sourceXR06AXL339A001010783044NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20243697See sourceNot stated by sourceXR06AXL339A001010784643NHSA
Hefei En Rui Te Pharma Co., Ltd. romanized国药准字H20243053See sourceNot stated by sourceXR06AXL339A001010810237NHSA
Noucor Health S.A.国药准字HJ20200036See sourceNot stated by sourceXR06AXL339A001010883044NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20243697See sourceNot stated by sourceXR06AXL339A001010884643NHSA
Hefei En Rui Te Pharma Co., Ltd. romanized国药准字H20243053See sourceNot stated by sourceXR06AXL339A001010910237NHSA
Noucor Health S.A.国药准字HJ20200036See sourceNot stated by sourceXR06AXL339A001010983044NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20243697See sourceNot stated by sourceXR06AXL339A001010984643NHSA
Hefei En Rui Te Pharma Co., Ltd. romanized国药准字H20243053See sourceNot stated by sourceXR06AXL339A001011010237NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20243697See sourceNot stated by sourceXR06AXL339A001011084643NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20243697See sourceNot stated by sourceXR06AXL339A001011184643NHSA
Jiangsu Vanguard Pharmaceutical Co., Ltd.国药准字H20243697See sourceNot stated by sourceXR06AXL339A001011284643NHSA
Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H20140097See sourceNot stated by sourceXR06AXL339A001020100151NHSA
Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H20140097See sourceNot stated by sourceXR06AXL339A001030100151NHSA
Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H20140097See sourceNot stated by sourceXR06AXL339A001030200151NHSA
Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H20140097See sourceNot stated by sourceXR06AXL339A001030300151NHSA

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: 2 filings and 2 distinct first applicants.

Generic 2

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Hainan Sai Li Ke Pharma Co., Ltd. romanizedCYHS2602587Generic2026/10/21Not stated by sourceCDE
Hubei Wei Sen Pharmaceutical Co., Ltd. romanizedCYHS2600248Generic2026/01/22Not stated by sourceCDE
New generic filings in 2026

Loaded records: 2 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Hainan Sai Li Ke Pharma Co., Ltd. romanizedCYHS2602587Generic2026/10/21Not stated by sourceCDE
Hubei Wei Sen Pharmaceutical Co., Ltd. romanizedCYHS2600248Generic2026/01/22Not stated by sourceCDE
API registrations

Non-component matches: 8 companies with A status and 2 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
富马酸卢帕他定 · No verified English nameHeilongjiang Zhen Bao Dao Pharma Co., Ltd. Ji Xi Branch romanizedY20230001300AExact ingredient2025/06/24CDE
富马酸卢帕他定 · No verified English nameZhejiang Sai Mo Pharmaceutical Co., Ltd. romanizedY20220000800AExact ingredient2026/11/10CDE
富马酸卢帕他定 · No verified English nameZhejiang Ci Fu Pharmaceuticals Co., Ltd. romanizedY20210001308IExact ingredient—CDE
富马酸卢帕他定 · No verified English nameHefei En Rui Te Pharma Co., Ltd. romanizedY20210001270AExact ingredient2024/07/24CDE
富马酸卢帕他定 · No verified English nameCADILA PHARMACEUTICALS LIMITEDY20200001379AExact ingredient2024/01/17CDE
富马酸卢帕他定 · No verified English nameYang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanizedY20190009831AExact ingredient2023/03/24CDE
富马酸卢帕他定 · No verified English nameDe Zhou Bo Cheng Pharmaceutical Co., Ltd. romanizedY20190008346AExact ingredient—CDE
富马酸卢帕他定 · No verified English nameHai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanizedY20190007397AExact ingredient2023/08/10CDE
富马酸卢帕他定 · No verified English nameYang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanizedY20180000691AExact ingredient2026/06/12CDE
富马酸卢帕他定 · No verified English nameUrquima S.A.Y20170001659AExact ingredient2024/10/29CDE
富马酸卢帕他定 · No verified English nameZhejiang Ci Fu Pharmaceuticals Co., Ltd. romanizedY20170000404IExact 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: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.

This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.

  1. 2026/10/21Accepted

    Hainan Sai Li Ke Pharma Co., Ltd. romanized

    CYHS2602587

    Fact date: 2026/10/21 · Site observation date: 2026/10/22

    View source ↗

How current is each source?

CDE acceptances and review
Last successful update: 2026/11/13 06:42
Chemical-drug catalogue
Last successful update: 2026/11/13 06:39

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: 2026/11/13 06:41
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: 2026/11/12 18:32 · Current coverage may be incomplete

First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.

Drug Clinical Trial Registry and Information Disclosure Platform
Last successful update: 2026/11/13 08:09 · 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: 7/30; discovered pending details: 13. 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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