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Sign in to subscribeAs 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
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.
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 |
|---|---|---|---|---|---|---|
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20254650 | 2025/06/24 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20253330 | 2025/01/24 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Foyou Pharma CO.,LTD | Beijing Foyou Pharma CO.,LTD | 国药准字H20249437 | 2024/11/22 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H20249163 | 2024/10/22 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Rui Yang Pharmaceutical Co., Ltd. romanized | Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20244713 | 2024/08/20 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20244531 | 2024/07/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Name not romanized | Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20243697 | 2024/05/15 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hefei En Rui Te Pharma Co., Ltd. romanized | Hefei En Rui Te Pharma Co., Ltd. romanized | 国药准字H20243053 | 2024/01/16 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20140097 | 2023/09/26 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized | Hai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized | 国药准字H20140026 | 2023/07/25 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized | Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized | 国药准字H20173112 | 2022/11/10 | See source | Drug that passed quality-and-efficacy consistency evaluation | 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.
Loaded records: 12 distinct approval numbers and 12 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20140097 | See source | Not stated by source | XR06AXL339A001010100151 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20249437 | See source | Not stated by source | XR06AXL339A001010100177 | NHSA |
| Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized | 国药准字H20173112 | See source | Not stated by source | XR06AXL339A001010101749 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20244713 | See source | Not stated by source | XR06AXL339A001010104152 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20244531 | See source | Not stated by source | XR06AXL339A001010104647 | NHSA |
| Hefei En Rui Te Pharma Co., Ltd. romanized | 国药准字H20243053 | See source | Not stated by source | XR06AXL339A001010110237 | NHSA |
| Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20140026 | See source | Not stated by source | XR06AXL339A001010179282 | NHSA |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H20249163 | See source | Not stated by source | XR06AXL339A001010182922 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20253330 | See source | Not stated by source | XR06AXL339A001010183034 | NHSA |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20254650 | See source | Not stated by source | XR06AXL339A001010183549 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20243697 | See source | Not stated by source | XR06AXL339A001010184643 | NHSA |
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20140097 | See source | Not stated by source | XR06AXL339A001010200151 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20249437 | See source | Not stated by source | XR06AXL339A001010200177 | NHSA |
| Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized | 国药准字H20173112 | See source | Not stated by source | XR06AXL339A001010201749 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20244713 | See source | Not stated by source | XR06AXL339A001010204152 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20244531 | See source | Not stated by source | XR06AXL339A001010204647 | NHSA |
| Hefei En Rui Te Pharma Co., Ltd. romanized | 国药准字H20243053 | See source | Not stated by source | XR06AXL339A001010210237 | NHSA |
| Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20140026 | See source | Not stated by source | XR06AXL339A001010279282 | NHSA |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H20249163 | See source | Not stated by source | XR06AXL339A001010282922 | NHSA |
| Noucor Health S.A. | 国药准字HJ20200036 | See source | Not stated by source | XR06AXL339A001010283044 | NHSA |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20254650 | See source | Not stated by source | XR06AXL339A001010283549 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20243697 | See source | Not stated by source | XR06AXL339A001010284643 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20249437 | See source | Not stated by source | XR06AXL339A001010300177 | NHSA |
| Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized | 国药准字H20173112 | See source | Not stated by source | XR06AXL339A001010301749 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20244713 | See source | Not stated by source | XR06AXL339A001010304152 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20244531 | See source | Not stated by source | XR06AXL339A001010304647 | NHSA |
| Hefei En Rui Te Pharma Co., Ltd. romanized | 国药准字H20243053 | See source | Not stated by source | XR06AXL339A001010310237 | NHSA |
| Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20140026 | See source | Not stated by source | XR06AXL339A001010379282 | NHSA |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H20249163 | See source | Not stated by source | XR06AXL339A001010382922 | NHSA |
| Noucor Health S.A. | 国药准字HJ20200036 | See source | Not stated by source | XR06AXL339A001010383044 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20243697 | See source | Not stated by source | XR06AXL339A001010384643 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20249437 | See source | Not stated by source | XR06AXL339A001010400177 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20244713 | See source | Not stated by source | XR06AXL339A001010404152 | NHSA |
| Hefei En Rui Te Pharma Co., Ltd. romanized | 国药准字H20243053 | See source | Not stated by source | XR06AXL339A001010410237 | NHSA |
| Noucor Health S.A. | 国药准字HJ20200036 | See source | Not stated by source | XR06AXL339A001010483044 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20243697 | See source | Not stated by source | XR06AXL339A001010484643 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20249437 | See source | Not stated by source | XR06AXL339A001010500177 | NHSA |
| Hefei En Rui Te Pharma Co., Ltd. romanized | 国药准字H20243053 | See source | Not stated by source | XR06AXL339A001010510237 | NHSA |
| Noucor Health S.A. | 国药准字HJ20200036 | See source | Not stated by source | XR06AXL339A001010583044 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20243697 | See source | Not stated by source | XR06AXL339A001010584643 | NHSA |
| Hefei En Rui Te Pharma Co., Ltd. romanized | 国药准字H20243053 | See source | Not stated by source | XR06AXL339A001010610237 | NHSA |
| Noucor Health S.A. | 国药准字HJ20200036 | See source | Not stated by source | XR06AXL339A001010683044 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20243697 | See source | Not stated by source | XR06AXL339A001010684643 | NHSA |
| Hefei En Rui Te Pharma Co., Ltd. romanized | 国药准字H20243053 | See source | Not stated by source | XR06AXL339A001010710237 | NHSA |
| Noucor Health S.A. | 国药准字HJ20200036 | See source | Not stated by source | XR06AXL339A001010783044 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20243697 | See source | Not stated by source | XR06AXL339A001010784643 | NHSA |
| Hefei En Rui Te Pharma Co., Ltd. romanized | 国药准字H20243053 | See source | Not stated by source | XR06AXL339A001010810237 | NHSA |
| Noucor Health S.A. | 国药准字HJ20200036 | See source | Not stated by source | XR06AXL339A001010883044 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20243697 | See source | Not stated by source | XR06AXL339A001010884643 | NHSA |
| Hefei En Rui Te Pharma Co., Ltd. romanized | 国药准字H20243053 | See source | Not stated by source | XR06AXL339A001010910237 | NHSA |
| Noucor Health S.A. | 国药准字HJ20200036 | See source | Not stated by source | XR06AXL339A001010983044 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20243697 | See source | Not stated by source | XR06AXL339A001010984643 | NHSA |
| Hefei En Rui Te Pharma Co., Ltd. romanized | 国药准字H20243053 | See source | Not stated by source | XR06AXL339A001011010237 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20243697 | See source | Not stated by source | XR06AXL339A001011084643 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20243697 | See source | Not stated by source | XR06AXL339A001011184643 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20243697 | See source | Not stated by source | XR06AXL339A001011284643 | NHSA |
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20140097 | See source | Not stated by source | XR06AXL339A001020100151 | NHSA |
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20140097 | See source | Not stated by source | XR06AXL339A001030100151 | NHSA |
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20140097 | See source | Not stated by source | XR06AXL339A001030200151 | NHSA |
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20140097 | See source | 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.
Loaded records: 2 filings and 2 distinct first applicants.
Generic 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hainan Sai Li Ke Pharma Co., Ltd. romanized | CYHS2602587 | Generic | 2026/10/21 | Not stated by source | CDE |
| Hubei Wei Sen Pharmaceutical Co., Ltd. romanized | CYHS2600248 | Generic | 2026/01/22 | Not stated by source | CDE |
Loaded records: 2 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hainan Sai Li Ke Pharma Co., Ltd. romanized | CYHS2602587 | Generic | 2026/10/21 | Not stated by source | CDE |
| Hubei Wei Sen Pharmaceutical Co., Ltd. romanized | CYHS2600248 | Generic | 2026/01/22 | Not stated by source | CDE |
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 · No verified English name | Heilongjiang Zhen Bao Dao Pharma Co., Ltd. Ji Xi Branch romanized | Y20230001300 | A | Exact ingredient | 2025/06/24 | CDE |
| 富马酸卢帕他定 · No verified English name | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | Y20220000800 | A | Exact ingredient | 2026/11/10 | CDE |
| 富马酸卢帕他定 · No verified English name | Zhejiang Ci Fu Pharmaceuticals Co., Ltd. romanized | Y20210001308 | I | Exact ingredient | — | CDE |
| 富马酸卢帕他定 · No verified English name | Hefei En Rui Te Pharma Co., Ltd. romanized | Y20210001270 | A | Exact ingredient | 2024/07/24 | CDE |
| 富马酸卢帕他定 · No verified English name | CADILA PHARMACEUTICALS LIMITED | Y20200001379 | A | Exact ingredient | 2024/01/17 | CDE |
| 富马酸卢帕他定 · No verified English name | Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20190009831 | A | Exact ingredient | 2023/03/24 | CDE |
| 富马酸卢帕他定 · No verified English name | De Zhou Bo Cheng Pharmaceutical Co., Ltd. romanized | Y20190008346 | A | Exact ingredient | — | CDE |
| 富马酸卢帕他定 · No verified English name | Hai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized | Y20190007397 | A | Exact ingredient | 2023/08/10 | CDE |
| 富马酸卢帕他定 · No verified English name | Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20180000691 | A | Exact ingredient | 2026/06/12 | CDE |
| 富马酸卢帕他定 · No verified English name | Urquima S.A. | Y20170001659 | A | Exact ingredient | 2024/10/29 | CDE |
| 富马酸卢帕他定 · No verified English name | Zhejiang Ci Fu Pharmaceuticals Co., Ltd. romanized | 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.
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.
CYHS2602587
Fact date: 2026/10/21 · Site observation date: 2026/10/22
View source ↗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.
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.
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.
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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