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Sign in to subscribeDotinurad Tablets
As of 13 November 2026, for Dotinurad Tablets, 55 applications are listed as under review at China's CDE; 26 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 0 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 25 applicationsTrial registration: 12 applicationsApproval-document delivery record: 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.
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.
Catalogue holders0View records ↓
Under-review filings55View records ↓
This year’s generic filers26View records ↓
NHSA approval numbers1View records ↓
API companies with A status1View records ↓
Chemical-drug catalogue
Loaded records: 0 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 0 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 |
|---|---|---|---|---|---|---|
| No matching records were found in the currently loaded source data; coverage dates are listed below. | ||||||
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: 1 distinct approval numbers and 1 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| FUJI YAKUHIN CO., LTD. | 国药准字HJ20240164 | 2mg | Category B | XM04ABD376A001010185383 | NHSA |
| FUJI YAKUHIN CO., LTD. | 国药准字HJ20240164 | 2mg | Category B | XM04ABD376A001010285383 | 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: 55 filings and 28 distinct first applicants.
Generic 55
New generic filings in 2026
Loaded records: 51 filings and 26 distinct first applicants.
API registrations
Non-component matches: 1 companies with A status and 19 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 |
|---|---|---|---|---|---|---|
| 多替诺雷 · No verified English name | Hebei Hua Chen Pharma Group Co., Ltd. romanized | Y20260000734 | I | Exact ingredient | 2026/10/10 | CDE |
| 多替诺雷 · No verified English name | Lu Zhou Ke Rui De Pharmaceutical Co., Ltd. romanized | Y20260000807 | I | Exact ingredient | 2026/09/24 | CDE |
| 多替诺雷 · No verified English name | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized | Y20260000785 | I | Exact ingredient | 2026/09/16 | CDE |
| 多替诺雷 · No verified English name | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | Y20260000753 | I | Exact ingredient | 2026/09/11 | CDE |
| 多替诺雷 · No verified English name | Sichuan Xin Kai Yuan Pharmaceutical Co., Ltd. romanized | Y20260000713 | I | Exact ingredient | 2026/08/20 | CDE |
| 多替诺雷 · No verified English name | Wuhan Wu Yao Pharmaceutical Co., Ltd. romanized | Y20260000645 | I | Exact ingredient | 2026/07/27 | CDE |
| 多替诺雷 · No verified English name | Shandong Ai Ge Lin Pharmaceutical Co., Ltd. romanized | Y20260000325 | I | Exact ingredient | 2026/05/27 | CDE |
| 多替诺雷 · No verified English name | Zhuhai Hai Rui De Pharmaceutical Co., Ltd. romanized | Y20260000266 | I | Exact ingredient | 2026/05/06 | CDE |
| 多替诺雷 · No verified English name | Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd. | Y20260000047 | I | Exact ingredient | 2026/04/27 | CDE |
| 多替诺雷 · No verified English name | Hua Bei Pharmaceutical Hua Sheng Co., Ltd. romanized | Y20260000219 | I | Exact ingredient | 2026/04/08 | CDE |
| 多替诺雷 · No verified English name | Sichuan Gowell Pharmaceutical Co., Ltd. | Y20260000125 | I | Exact ingredient | 2026/03/02 | CDE |
| 多替诺雷 · No verified English name | Hubei Tian Shu Pharma Co., Ltd. romanized | Y20260000134 | I | Exact ingredient | 2026/02/27 | CDE |
| 多替诺雷 · No verified English name | Wei Nan Rui Lian Pharmaceutical Co., Ltd. romanized | Y20250001385 | I | Exact ingredient | 2026/01/29 | CDE |
| 多替诺雷 · No verified English name | Jilin Sheng Bo Da Pharmaceutical Co., Ltd. romanized | Y20250001494 | I | Exact ingredient | 2026/01/22 | CDE |
| 多替诺雷 · No verified English name | Jiangsu Deyuan Pharmaceutical Co.,Ltd. | Y20250001328 | I | Exact ingredient | 2025/12/23 | CDE |
| 多替诺雷 · No verified English name | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized | Y20250001188 | I | Exact ingredient | 2025/11/12 | CDE |
| 多替诺雷 · No verified English name | Shanghai Di Sai Nuo Chemical Pharmaceutical Co., Ltd. romanized | Y20250001101 | I | Exact ingredient | 2025/11/10 | CDE |
| 多替诺雷 · No verified English name | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | Y20250000686 | I | Exact ingredient | 2025/07/21 | CDE |
| 多替诺雷 · No verified English name | Guangdong Xian Qiang Pharma Co., Ltd. romanized | Y20250000665 | I | Exact ingredient | 2025/07/08 | CDE |
| 多替诺雷 · No verified English name | Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | Y20250000660 | A | Exact ingredient | 2026/10/12 | 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.
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.
-
2026/11/12Trial registration
Jiangsu Vanguard Pharmaceutical Co., Ltd.
CTR20264315
First-publication date: 2026/11/12 · Site observation date: 2026/11/13
Read by this site on 2026/11/13 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
View source ↗ -
2026/11/12Accepted
Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized
CYHS2602799
Fact date: 2026/11/12 · Site observation date: 2026/11/13
View source ↗ -
2026/11/12Accepted
Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized
CYHS2602798
Fact date: 2026/11/12 · Site observation date: 2026/11/13
View source ↗ -
2026/11/10Accepted
Shandong Cheng Chuang Lan Hai Pharmaceuticals Technology Co., Ltd. romanized; Yi Nan Li Nuo Pharmaceutical Co., Ltd. romanized
CYHS2602762
Fact date: 2026/11/10 · Site observation date: 2026/11/11
View source ↗ -
2026/11/10Accepted
Shandong Cheng Chuang Lan Hai Pharmaceuticals Technology Co., Ltd. romanized; Yi Nan Li Nuo Pharmaceutical Co., Ltd. romanized
CYHS2602761
Fact date: 2026/11/10 · Site observation date: 2026/11/11
View source ↗ -
2026/11/06Trial registration
Shaanxi Tian Yu Pharmaceutical Co., Ltd. romanized
CTR20264224
First-publication date: 2026/11/06 · Site observation date: 2026/11/10
Read by this site on 2026/11/10 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/11/05Accepted
Yuan Da Pharmaceuticals (Hubei) Co., Ltd. romanized; Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized
CYHS2602722
Fact date: 2026/11/05 · Site observation date: 2026/11/06
View source ↗ -
2026/11/05Accepted
Yuan Da Pharmaceuticals (Hubei) Co., Ltd. romanized; Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized
CYHS2602721
Fact date: 2026/11/05 · Site observation date: 2026/11/06
View source ↗ -
2026/10/27Trial registration
Jiangsu Shen Hua Pharma Co., Ltd. romanized
CTR20263372
First-publication date: 2026/10/27 · Site observation date: 2026/11/10
Read by this site on 2026/11/10 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/10/22Accepted
Anhui Pioneer Pharmaceutical Co., Ltd
CYHS2602598
Fact date: 2026/10/22 · Site observation date: 2026/10/23
View source ↗ -
2026/10/22Accepted
Anhui Pioneer Pharmaceutical Co., Ltd
CYHS2602597
Fact date: 2026/10/22 · Site observation date: 2026/10/23
View source ↗ -
2026/10/21Trial registration
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
CTR20264007
First-publication date: 2026/10/21 · Site observation date: 2026/11/10
Read by this site on 2026/11/10 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/10/20Trial registration
Huayi Pharmaceuticals (Anhui) Co., Ltd.
CTR20263830
First-publication date: 2026/10/20 · Site observation date: 2026/11/10
Read by this site on 2026/11/10 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/10/16Approval-document delivery record
Shanghai Han He Rui Pharmaceuticals Technology Co., Ltd. romanized
JTH2600197
Fact date: 2026/10/16 · Publication date: 2026/10/19 · Site observation date: 2026/11/03
View source · Table row 29 ↗ -
2026/10/14Accepted
Hunan Zhuang Yuan Pharmaceutical Co., Ltd. romanized; Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized
CYHS2602523
Fact date: 2026/10/14 · Site observation date: 2026/10/22
View source ↗ -
2026/10/14Accepted
Hunan Zhuang Yuan Pharmaceutical Co., Ltd. romanized; Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized
CYHS2602522
Fact date: 2026/10/14 · Site observation date: 2026/10/22
View source ↗ -
2026/10/13Accepted
Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized
CYHS2602505
Fact date: 2026/10/13 · Site observation date: 2026/10/22
View source ↗ -
2026/10/13Accepted
Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized
CYHS2602504
Fact date: 2026/10/13 · Site observation date: 2026/10/22
View source ↗ -
2026/10/10Accepted
Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized
CYHS2602480
Fact date: 2026/10/10 · Site observation date: 2026/10/22
View source ↗ -
2026/10/10Accepted
Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized
CYHS2602479
Fact date: 2026/10/10 · Site observation date: 2026/10/22
View source ↗ -
2026/09/30Accepted
NORTH CHINA PHARMACEUTICAL COMPANY.LTD
CYHS2602438
Fact date: 2026/09/30 · Site observation date: 2026/10/22
View source ↗ -
2026/09/30Accepted
NORTH CHINA PHARMACEUTICAL COMPANY.LTD
CYHS2602437
Fact date: 2026/09/30 · Site observation date: 2026/10/22
View source ↗ -
2026/09/29Trial registration
Jiangsu Dong Ke Kang De Pharma Co., Ltd. romanized
CTR20263755
First-publication date: 2026/09/29 · Site observation date: 2026/11/10
Read by this site on 2026/11/10 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/09/28Trial registration
Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized
CTR20263744
First-publication date: 2026/09/28 · Site observation date: 2026/11/10
Read by this site on 2026/11/10 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/09/24Trial registration
Zhong Xi (Fujian) Pharma Co., Ltd. romanized
CTR20263582
First-publication date: 2026/09/24 · Site observation date: 2026/11/10
Read by this site on 2026/11/10 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/09/18Accepted
Name not romanized; Shanghai Han He Rui Pharmaceuticals Technology Co., Ltd. romanized
JTH2600197
Fact date: 2026/09/18 · Site observation date: 2026/10/22
View source ↗ -
2026/09/17Accepted
Hai Chuang Pharma Co., Ltd. romanized
CYHS2602323
Fact date: 2026/09/17 · Site observation date: 2026/10/22
View source ↗ -
2026/09/15Accepted
Zhu Shi Hui She Fu Shi Cai Pin romanized; Zhu Shi Hui She Fu Shi Gao Pin romanized; Shanghai Bo Yue Bio Technology Co., Ltd. romanized
JTH2600193
Fact date: 2026/09/15 · Site observation date: 2026/10/22
View source ↗ -
2026/09/07Accepted
Jiangxi Shimei Pharmaceutical Co., Ltd
CYHS2602223
Fact date: 2026/09/07 · Site observation date: 2026/10/22
View source ↗ -
2026/09/07Accepted
Jiangxi Shimei Pharmaceutical Co., Ltd
CYHS2602221
Fact date: 2026/09/07 · Site observation date: 2026/10/22
View source ↗ -
2026/09/03Trial registration
Da Lian Mei Chuang Pharma Co., Ltd. romanized
CTR20263424
First-publication date: 2026/09/03 · Site observation date: 2026/11/10
Read by this site on 2026/11/10 as “Completed”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/08/25Accepted
Zhejiang Yi Han Pharmaceutical Co., Ltd. romanized
CYHS2602122
Fact date: 2026/08/25 · Site observation date: 2026/10/22
View source ↗ -
2026/08/25Accepted
Zhejiang Yi Han Pharmaceutical Co., Ltd. romanized
CYHS2602121
Fact date: 2026/08/25 · Site observation date: 2026/10/22
View source ↗ -
2026/08/25Accepted
Jiu Hua Hua Yuan Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized
CYHS2602113
Fact date: 2026/08/25 · Site observation date: 2026/10/22
View source ↗ -
2026/08/25Accepted
Jiu Hua Hua Yuan Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
CYHS2602112
Fact date: 2026/08/25 · Site observation date: 2026/10/22
View source ↗ -
2026/08/20Trial registration
Nanchang Hong Yi Pharma Co., Ltd. romanized
CTR20263189
First-publication date: 2026/08/20 · Site observation date: 2026/11/10
Read by this site on 2026/11/10 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/08/19Trial registration
Haerbin Hua Rui Sheng Hua Pharma Co., Ltd. romanized
CTR20263223
First-publication date: 2026/08/19 · Site observation date: 2026/11/10
Read by this site on 2026/11/10 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/08/17Trial registration
Zhejiang Shan Yuan Pharmaceutical Co., Ltd. romanized
CTR20263117
First-publication date: 2026/08/17 · Site observation date: 2026/11/10
Read by this site on 2026/11/10 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
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.
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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