Monthly
US$200
Billed every month
Rupatadine Fumarate Tablets(富马酸卢帕他定片)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 1 application
Current coverage may be incomplete
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.
Catalogue holders11View records ↓
Under-review filings2View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers12View records ↓
API companies with A status8View records ↓
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 holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| 浙江赛默制药有限公司 | 浙江赛默制药有限公司 | 国药准字H20254650 | 2025/06/24 | 10mg（按C26H26ClN3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 |
| 山东华铂凯盛生物科技有限公司 | 安徽泰恩康制药有限公司 | 国药准字H20253330 | 2025/01/24 | 10mg（按C26H26ClN3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 |
| 北京福元医药股份有限公司 | 北京福元医药股份有限公司 | 国药准字H20249437 | 2024/11/22 | 10mg（按C26H26ClN3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 |
| 浙江普利药业有限公司 | 浙江普利药业有限公司 | 国药准字H20249163 | 2024/10/22 | 10mg（按C26H26ClN3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 |
| 瑞阳制药股份有限公司 | 瑞阳制药股份有限公司 | 国药准字H20244713 | 2024/08/20 | 10mg（按C26H26ClN3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 |
| 浙江华海药业股份有限公司 | 浙江华海药业股份有限公司 | 国药准字H20244531 | 2024/07/30 | 10mg（按C26H26ClN3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 |
| 江苏万珺医药科技有限公司 | 江苏万高药业股份有限公司 | 国药准字H20243697 | 2024/05/15 | 10mg（按C26H26ClN3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 |
| 合肥恩瑞特药业有限公司 | 合肥恩瑞特药业有限公司 | 国药准字H20243053 | 2024/01/16 | 10mg（按C26H26ClN3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 |
| 北京四环科宝制药股份有限公司 | 北京四环科宝制药股份有限公司 | 国药准字H20140097 | 2023/09/26 | 10mg(以卢帕他定计) | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 海思科医药集团股份有限公司 | 海思科制药（眉山）有限公司 | 国药准字H20140026 | 2023/07/25 | 10mg（以C26H26ClN3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 |
| 扬子江药业集团江苏紫龙药业有限公司 | 扬子江药业集团江苏紫龙药业有限公司 | 国药准字H20173112 | 2022/11/10 | 10mg（按C26H26ClN3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 |
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 / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 北京四环科宝制药股份有限公司 | 国药准字H20140097 | 10mg(以C26H26C1N3计 ) | Not stated by source | XR06AXL339A001010100151 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20249437 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010100177 | NHSA |
| 扬子江药业集团江苏紫龙药业有限公司 | 国药准字H20173112 | 10mg(以C26H26ClN3计) | Not stated by source | XR06AXL339A001010101749 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20244713 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010104152 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20244531 | 10mg(按C26H26ClN3计) | Not stated by source | XR06AXL339A001010104647 | NHSA |
| 合肥恩瑞特药业有限公司 | 国药准字H20243053 | 10mg(按C26H26ClN3计) | Not stated by source | XR06AXL339A001010110237 | NHSA |
| 海思科医药集团股份有限公司 | 国药准字H20140026 | 10mg(以C26H26CIN3计) | Not stated by source | XR06AXL339A001010179282 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20249163 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010182922 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20253330 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010183034 | NHSA |
| 浙江赛默制药有限公司 | 国药准字H20254650 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010183549 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20243697 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010184643 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20140097 | 10mg(以C26H26C1N3计 ) | Not stated by source | XR06AXL339A001010200151 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20249437 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010200177 | NHSA |
| 扬子江药业集团江苏紫龙药业有限公司 | 国药准字H20173112 | 10mg(以C26H26ClN3计) | Not stated by source | XR06AXL339A001010201749 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20244713 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010204152 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20244531 | 10mg(按C26H26ClN3计) | Not stated by source | XR06AXL339A001010204647 | NHSA |
| 合肥恩瑞特药业有限公司 | 国药准字H20243053 | 10mg(按C26H26ClN3计) | Not stated by source | XR06AXL339A001010210237 | NHSA |
| 海思科医药集团股份有限公司 | 国药准字H20140026 | 10mg(以C26H26CIN3计) | Not stated by source | XR06AXL339A001010279282 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20249163 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010282922 | NHSA |
| Noucor Health S.A. | 国药准字HJ20200036 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010283044 | NHSA |
| 浙江赛默制药有限公司 | 国药准字H20254650 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010283549 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20243697 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010284643 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20249437 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010300177 | NHSA |
| 扬子江药业集团江苏紫龙药业有限公司 | 国药准字H20173112 | 10mg(以C26H26ClN3计) | Not stated by source | XR06AXL339A001010301749 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20244713 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010304152 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20244531 | 10mg(按C26H26ClN3计) | Not stated by source | XR06AXL339A001010304647 | NHSA |
| 合肥恩瑞特药业有限公司 | 国药准字H20243053 | 10mg(按C26H26ClN3计) | Not stated by source | XR06AXL339A001010310237 | NHSA |
| 海思科医药集团股份有限公司 | 国药准字H20140026 | 10mg(以C26H26CIN3计) | Not stated by source | XR06AXL339A001010379282 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20249163 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010382922 | NHSA |
| Noucor Health S.A. | 国药准字HJ20200036 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010383044 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20243697 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010384643 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20249437 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010400177 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20244713 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010404152 | NHSA |
| 合肥恩瑞特药业有限公司 | 国药准字H20243053 | 10mg(按C26H26ClN3计) | Not stated by source | XR06AXL339A001010410237 | NHSA |
| Noucor Health S.A. | 国药准字HJ20200036 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010483044 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20243697 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010484643 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20249437 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010500177 | NHSA |
| 合肥恩瑞特药业有限公司 | 国药准字H20243053 | 10mg(按C26H26ClN3计) | Not stated by source | XR06AXL339A001010510237 | NHSA |
| Noucor Health S.A. | 国药准字HJ20200036 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010583044 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20243697 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010584643 | NHSA |
| 合肥恩瑞特药业有限公司 | 国药准字H20243053 | 10mg(按C26H26ClN3计) | Not stated by source | XR06AXL339A001010610237 | NHSA |
| Noucor Health S.A. | 国药准字HJ20200036 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010683044 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20243697 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010684643 | NHSA |
| 合肥恩瑞特药业有限公司 | 国药准字H20243053 | 10mg(按C26H26ClN3计) | Not stated by source | XR06AXL339A001010710237 | NHSA |
| Noucor Health S.A. | 国药准字HJ20200036 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010783044 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20243697 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010784643 | NHSA |
| 合肥恩瑞特药业有限公司 | 国药准字H20243053 | 10mg(按C26H26ClN3计) | Not stated by source | XR06AXL339A001010810237 | NHSA |
| Noucor Health S.A. | 国药准字HJ20200036 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010883044 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20243697 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010884643 | NHSA |
| 合肥恩瑞特药业有限公司 | 国药准字H20243053 | 10mg(按C26H26ClN3计) | Not stated by source | XR06AXL339A001010910237 | NHSA |
| Noucor Health S.A. | 国药准字HJ20200036 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010983044 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20243697 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001010984643 | NHSA |
| 合肥恩瑞特药业有限公司 | 国药准字H20243053 | 10mg(按C26H26ClN3计) | Not stated by source | XR06AXL339A001011010237 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20243697 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001011084643 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20243697 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001011184643 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20243697 | 10mg(按C₂₆H₂₆ClN₃计) | Not stated by source | XR06AXL339A001011284643 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20140097 | 10mg(以C26H26C1N3计 ) | Not stated by source | XR06AXL339A001020100151 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20140097 | 10mg(以C26H26C1N3计 ) | Not stated by source | XR06AXL339A001030100151 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20140097 | 10mg(以C26H26C1N3计 ) | Not stated by source | XR06AXL339A001030200151 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20140097 | 10mg(以C26H26C1N3计 ) | Not stated by source | XR06AXL339A001030300151 | NHSA |
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
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
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.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 富马酸卢帕他定 | 黑龙江珍宝岛药业股份有限公司鸡西分公司 | Y20230001300 | A | Exact ingredient | 2025/06/24 | CDE |
| 富马酸卢帕他定 | 浙江赛默制药有限公司 | Y20220000800 | A | Exact ingredient | 2025/09/13 | CDE |
| 富马酸卢帕他定 | 浙江赐富医药有限公司 | Y20210001308 | I | Exact ingredient | — | CDE |
| 富马酸卢帕他定 | 合肥恩瑞特药业有限公司 | Y20210001270 | A | Exact ingredient | 2024/07/24 | CDE |
| 富马酸卢帕他定 | CADILA PHARMACEUTICALS LIMITED | Y20200001379 | A | Exact ingredient | 2024/01/17 | CDE |
| 富马酸卢帕他定 | 扬子江药业集团江苏海慈生物药业有限公司 | Y20190009831 | A | Exact ingredient | 2023/03/24 | CDE |
| 富马酸卢帕他定 | 德州博诚制药有限公司 | Y20190008346 | A | Exact ingredient | — | CDE |
| 富马酸卢帕他定 | 海思科制药（眉山）有限公司 | Y20190007397 | A | Exact ingredient | 2023/08/10 | CDE |
| 富马酸卢帕他定 | 扬子江药业集团江苏海慈生物药业有限公司 | Y20180000691 | A | Exact ingredient | 2026/06/12 | CDE |
| 富马酸卢帕他定 | Urquima S.A. | Y20170001659 | A | Exact ingredient | 2024/10/29 | CDE |
| 富马酸卢帕他定 | 浙江赐富医药有限公司 | Y20170000404 | I | Exact 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: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
-
2026/10/21Accepted
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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- Add up to 4 additional recipients, each confirmed by email.
- Increase your follow limit from 3 to 10 products.
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Yearly
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Billed every year
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US Orange Book × China records comparison
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
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US$490
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