Monthly
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Billed every month
Ketotifen Fumarate Oral Solution(富马酸酮替芬口服溶液)
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 holders0View records ↓
Under-review filings8View records ↓
This year’s generic filers5View records ↓
NHSA approval numbers2View records ↓
API companies with A status7View 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: 2 distinct approval numbers and 2 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 海口天行健药物研究有限公司 | 国药准字H20254155 | 150ml:30mg(按C₁₉H₁₉NOS计) | Not stated by source | XR06AXT061X001010183128 | NHSA |
| 浙江易泽达医药科技有限公司 | 国药准字H20254785 | 100毫升:20毫克(按酮替芬计) | Not stated by source | XR06AXT061X001010184709 | 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: 8 filings and 8 distinct first applicants.
Generic 8
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏润恒制药有限公司 | CYHS2501275 | Generic | 2025/04/03 | Not stated by source | CDE |
| 江苏欧歌制药有限公司 | CYHS2503352 | Generic | 2025/09/10 | Not stated by source | CDE |
| 广东南国药业有限公司 | CYHS2601132 | Generic | 2026/05/14 | Not stated by source | CDE |
| 西洲医药科技（浙江）有限公司;浙江北生药业汉生制药有限公司 | CYHS2600887 | Generic | 2026/04/17 | Not stated by source | CDE |
| 安徽远望乐桓药业有限公司 | CYHS2600784 | Generic | 2026/04/03 | Not stated by source | CDE |
| 浙江杭康药业有限公司 | CYHS2600673 | Generic | 2026/03/19 | Not stated by source | CDE |
| 安徽茂康药业有限公司;安徽永生堂药业有限责任公司 | CYHS2501921 | Generic | 2025/05/29 | Not stated by source | CDE |
| 大连百利天华制药有限公司;河南华雒康润药业有限公司 | CYHS2602662 | Generic | 2026/10/30 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 5 filings and 5 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 广东南国药业有限公司 | CYHS2601132 | Generic | 2026/05/14 | Not stated by source | CDE |
| 西洲医药科技（浙江）有限公司;浙江北生药业汉生制药有限公司 | CYHS2600887 | Generic | 2026/04/17 | Not stated by source | CDE |
| 安徽远望乐桓药业有限公司 | CYHS2600784 | Generic | 2026/04/03 | Not stated by source | CDE |
| 浙江杭康药业有限公司 | CYHS2600673 | Generic | 2026/03/19 | Not stated by source | CDE |
| 大连百利天华制药有限公司;河南华雒康润药业有限公司 | CYHS2602662 | Generic | 2026/10/30 | Not stated by source | CDE |
API registrations
Non-component matches: 7 companies with A status and 0 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 |
|---|---|---|---|---|---|---|
| 富马酸酮替芬 | 浙江尚泰生物制药有限公司 | Y20190006298 | A | Exact ingredient | 2026/09/18 | CDE |
| 富马酸酮替芬 | 国药集团致君（苏州）制药有限公司 | Y20190004356 | A | Exact ingredient | — | CDE |
| 富马酸酮替芬 | 台山市新宁制药有限公司 | Y20190003233 | A | Exact ingredient | 2026/02/28 | CDE |
| 富马酸酮替芬 | 苏州弘森药业股份有限公司 | Y20190003202 | A | Exact ingredient | 2025/06/07 | CDE |
| 富马酸酮替芬 | 浙江华海药业股份有限公司 | Y20190002575 | A | Exact ingredient | 2026/03/24 | CDE |
| 富马酸酮替芬 | 海南普利制药股份有限公司 | Y20190002543 | A | Exact ingredient | 2024/07/16 | CDE |
| 富马酸酮替芬 | 北京京丰制药（山东）有限公司 | Y20190001826 | A | 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.
-
2026/10/30Accepted
大连百利天华制药有限公司;河南华雒康润药业有限公司
CYHS2602662
Fact date: 2026/10/30 · Site observation date: 2026/10/31
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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