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Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 2 applications
Current coverage may be incomplete
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.
Loaded records: 4 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 4 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 |
|---|---|---|---|---|---|---|
| 浙江皓格药业有限公司 | 成都通德药业有限公司 | 国药准字H20263746 | 2026/03/31 | 0.2g | 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 |
| 福安药业集团庆余堂制药有限公司 | 福安药业集团庆余堂制药有限公司 | 国药准字H20263794 | 2026/03/31 | 0.1g | 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 |
| 福安药业集团庆余堂制药有限公司 | 福安药业集团庆余堂制药有限公司 | 国药准字H20263793 | 2026/03/31 | 0.2g | 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 |
| 甘正(海南)生物药业有限公司 | 海南科进生物制药有限公司 | 国药准字H20263418 | 2026/02/10 | 0.2g | 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 |
| 甘正(海南)生物药业有限公司 | 海南科进生物制药有限公司 | 国药准字H20263419 | 2026/02/10 | 0.15g | 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 |
| 沐源(安徽)药业有限公司 | 华益药业科技(安徽)有限公司 | 国药准字H20263315 | 2026/02/02 | 0.2g | 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 |
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: 9 distinct approval numbers and 7 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 福安药业集团庆余堂制药有限公司 | 国药准字H20263793 | 0.2g | Category B (乙) | XM01ABS092A001010101877 | NHSA |
| 青岛国信制药有限公司 | 国药准字H20033535 | 0.1g | Category B (乙) | XM01ABS092A001010104036 | NHSA |
| 宁波大红鹰药业股份有限公司 | 国药准字H10940091 | 0.1g | Category B (乙) | XM01ABS092A001010104554 | NHSA |
| 福安药业集团宁波天衡制药有限公司 | 国药准字H33021627 | 0.1g | Category B (乙) | XM01ABS092A001010104561 | NHSA |
| 海南科进生物制药有限公司 | 国药准字H20263419 | 0.15g | Category B (乙) | XM01ABS092A001010105819 | NHSA |
| 浙江皓格药业有限公司 | 国药准字H20263746 | 0.2g | Category B (乙) | XM01ABS092A001010183726 | NHSA |
| 沐源(安徽)药业有限公司 | 国药准字H20263315 | 0.2g | Category B (乙) | XM01ABS092A001010184519 | NHSA |
| 青岛国信制药有限公司 | 国药准字H20033535 | 0.1g | Category B (乙) | XM01ABS092A001010204036 | NHSA |
| 福安药业集团宁波天衡制药有限公司 | 国药准字H33021627 | 0.1g | Category B (乙) | XM01ABS092A001010204561 | NHSA |
| 海南科进生物制药有限公司 | 国药准字H20263419 | 0.15g | Category B (乙) | XM01ABS092A001010205819 | NHSA |
| 浙江皓格药业有限公司 | 国药准字H20263746 | 0.2g | Category B (乙) | XM01ABS092A001010283726 | NHSA |
| 沐源(安徽)药业有限公司 | 国药准字H20263315 | 0.2g | Category B (乙) | XM01ABS092A001010284519 | NHSA |
| 青岛国信制药有限公司 | 国药准字H20033535 | 0.1g | Category B (乙) | XM01ABS092A001010304036 | NHSA |
| 福安药业集团宁波天衡制药有限公司 | 国药准字H33021627 | 0.1g | Category B (乙) | XM01ABS092A001010304561 | NHSA |
| 海南科进生物制药有限公司 | 国药准字H20263419 | 0.15g | Category B (乙) | XM01ABS092A001010305819 | NHSA |
| 沐源(安徽)药业有限公司 | 国药准字H20263315 | 0.2g | Category B (乙) | XM01ABS092A001010384519 | NHSA |
| 青岛国信制药有限公司 | 国药准字H20033535 | 0.1g | Category B (乙) | XM01ABS092A001010404036 | NHSA |
| 福安药业集团庆余堂制药有限公司 | 国药准字H20263794 | 0.1g | Category B (乙) | XM01ABS092A001020101877 | NHSA |
| 宁波大红鹰药业股份有限公司 | 国药准字H10940091 | 0.1g | Category B (乙) | XM01ABS092A001020104554 | NHSA |
| 海南科进生物制药有限公司 | 国药准字H20263418 | 0.2g | Category B (乙) | XM01ABS092A001020105819 | NHSA |
| 宁波大红鹰药业股份有限公司 | 国药准字H10940091 | 0.1g | Category B (乙) | XM01ABS092A001020204554 | NHSA |
| 海南科进生物制药有限公司 | 国药准字H20263418 | 0.2g | Category B (乙) | XM01ABS092A001020205819 | NHSA |
| 海南科进生物制药有限公司 | 国药准字H20263418 | 0.2g | Category B (乙) | XM01ABS092A001020305819 | 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: 5 filings and 3 distinct first applicants.
Generic 5
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏万高药业股份有限公司 | CYHS2602279 | Generic | 2026/09/15 | Not stated by source | CDE |
| 江苏万高药业股份有限公司 | CYHS2602278 | Generic | 2026/09/15 | Not stated by source | CDE |
| 苏州朗科生物技术股份有限公司;成都通德药业有限公司 | CYHS2503125 | Generic | 2025/08/26 | Not stated by source | CDE |
| 江苏东科康德药业有限公司;广东星昊药业有限公司 | CYHS2600077 | Generic | 2026/01/08 | Not stated by source | CDE |
| 江苏东科康德药业有限公司;广东星昊药业有限公司 | CYHS2600076 | Generic | 2026/01/08 | Not stated by source | CDE |
Loaded records: 4 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏万高药业股份有限公司 | CYHS2602279 | Generic | 2026/09/15 | Not stated by source | CDE |
| 江苏万高药业股份有限公司 | CYHS2602278 | Generic | 2026/09/15 | Not stated by source | CDE |
| 江苏东科康德药业有限公司;广东星昊药业有限公司 | CYHS2600077 | Generic | 2026/01/08 | Not stated by source | CDE |
| 江苏东科康德药业有限公司;广东星昊药业有限公司 | CYHS2600076 | Generic | 2026/01/08 | Not stated by source | CDE |
Non-component matches: 4 companies with A status and 1 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 |
|---|---|---|---|---|---|---|
| 舒林酸 | 安徽修一制药有限公司 | Y20260000142 | I | Exact ingredient | 2026/03/06 | CDE |
| 舒林酸 | 杭州福斯特药业有限公司 | Y20240001431 | A | Exact ingredient | 2026/08/13 | CDE |
| 舒林酸 | 江苏诺泰澳赛诺生物制药股份有限公司 | Y20230001372 | A | Exact ingredient | 2026/07/09 | CDE |
| 舒林酸 | 宁波大红鹰药业股份有限公司 | Y20190002461 | A | Exact ingredient | 2025/01/03 | CDE |
| 舒林酸 | 福安药业集团宁波天衡制药有限公司 | Y20190001705 | A | Exact ingredient | 2025/02/20 | 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: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
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: 2026-10-26 to 2026-11-10; 0 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: 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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