Monthly
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Billed every month
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 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 3 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H20264956 | 2026/06/23 | 150mg(按C19H22ClN5O?HCl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 |
| 浙江赛默制药有限公司 | 浙江赛默制药有限公司 | 国药准字H20264957 | 2026/06/23 | 75mg(按C19H22ClN5O?HCl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 |
| 山东京卫制药有限公司 | 山东京卫制药有限公司 | 国药准字H20264979 | 2026/06/23 | 150mg | 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 |
| 江苏万高药业股份有限公司 | 江苏万高药业股份有限公司 | 国药准字H20263907 | 2026/04/07 | 150mg | 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 |
| 江苏万高药业股份有限公司 | 江苏万高药业股份有限公司 | 国药准字H20263908 | 2026/04/07 | 75mg | 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 |
| 深圳市泛谷药业股份有限公司 | 吉林天衡英睿制药有限公司 | 国药准字H20255489 | 2025/09/16 | 150mg(按C19H22ClN5O·HCl 计) | Not stated by source | 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: 8 distinct approval numbers and 5 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 江苏万高药业股份有限公司 | 国药准字H20263908 | 按C₁₉H₂₂ClN₅O·HCl计 75mg | Category B (乙) | XN06AXQ113A010010101503 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20264979 | 150mg(按C₁₉H₂₂ClN₅O·HCl 计) | Category B (乙) | XN06AXQ113A010010104111 | NHSA |
| AZ.CHIM.RIUN.ANGELINI FRANCESCO ACRAF S.P.A. | 国药准字HJ20200051 | 75mg | Category B (乙) | XN06AXQ113A010010182987 | NHSA |
| 深圳市泛谷药业股份有限公司 | 国药准字H20255489 | 150mg(按C₁₉H₂₂ClN₅O·HCl计) | Category B (乙) | XN06AXQ113A010010183251 | NHSA |
| 浙江赛默制药有限公司 | 国药准字H20264956 | 150mg(按C₁₉H₂₂ClN₅O・HCl 计) | Category B (乙) | XN06AXQ113A010010183549 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20263908 | 按C₁₉H₂₂ClN₅O·HCl计 75mg | Category B (乙) | XN06AXQ113A010010201503 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20264979 | 150mg(按C₁₉H₂₂ClN₅O·HCl 计) | Category B (乙) | XN06AXQ113A010010204111 | NHSA |
| AZ.CHIM.RIUN.ANGELINI FRANCESCO ACRAF S.P.A. | 国药准字HJ20200051 | 75mg | Category B (乙) | XN06AXQ113A010010282987 | NHSA |
| 浙江赛默制药有限公司 | 国药准字H20264956 | 150mg(按C₁₉H₂₂ClN₅O・HCl 计) | Category B (乙) | XN06AXQ113A010010283549 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20263908 | 按C₁₉H₂₂ClN₅O·HCl计 75mg | Category B (乙) | XN06AXQ113A010010301503 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20264979 | 150mg(按C₁₉H₂₂ClN₅O·HCl 计) | Category B (乙) | XN06AXQ113A010010304111 | NHSA |
| AZ.CHIM.RIUN.ANGELINI FRANCESCO ACRAF S.P.A. | 国药准字HJ20200051 | 75mg | Category B (乙) | XN06AXQ113A010010382987 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20263908 | 按C₁₉H₂₂ClN₅O·HCl计 75mg | Category B (乙) | XN06AXQ113A010010401503 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20263908 | 按C₁₉H₂₂ClN₅O·HCl计 75mg | Category B (乙) | XN06AXQ113A010010501503 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20263907 | 按C₁₉H₂₂ClN₅O·HCl计 150mg | Category B (乙) | XN06AXQ113A010020101503 | NHSA |
| AZ.CHIM.RIUN.ANGELINI FRANCESCO ACRAF S.P.A. | 国药准字HJ20200052 | 150mg | Category B (乙) | XN06AXQ113A010020182987 | NHSA |
| 浙江赛默制药有限公司 | 国药准字H20264957 | 75mg(按C₁₉H₂₂ClN₅O・HCl 计) | Category B (乙) | XN06AXQ113A010020183549 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20263907 | 按C₁₉H₂₂ClN₅O·HCl计 150mg | Category B (乙) | XN06AXQ113A010020201503 | NHSA |
| AZ.CHIM.RIUN.ANGELINI FRANCESCO ACRAF S.P.A. | 国药准字HJ20200052 | 150mg | Category B (乙) | XN06AXQ113A010020282987 | NHSA |
| 浙江赛默制药有限公司 | 国药准字H20264957 | 75mg(按C₁₉H₂₂ClN₅O・HCl 计) | Category B (乙) | XN06AXQ113A010020283549 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20263907 | 按C₁₉H₂₂ClN₅O·HCl计 150mg | Category B (乙) | XN06AXQ113A010020301503 | NHSA |
| 浙江赛默制药有限公司 | 国药准字H20264957 | 75mg(按C₁₉H₂₂ClN₅O・HCl 计) | Category B (乙) | XN06AXQ113A010020383549 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20263907 | 按C₁₉H₂₂ClN₅O·HCl计 150mg | Category B (乙) | XN06AXQ113A010020401503 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20263907 | 按C₁₉H₂₂ClN₅O·HCl计 150mg | Category B (乙) | XN06AXQ113A010020501503 | 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: 20 filings and 15 distinct first applicants.
Generic 20
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 重庆世森医药科技有限公司;烟台鲁银药业有限公司 | CYHS2600176 | Generic | 2026/01/14 | Not stated by source | CDE |
| 南京海纳制药有限公司 | CYHS2602191 | Generic | 2026/09/02 | Not stated by source | CDE |
| 南京海纳制药有限公司 | CYHS2602190 | Generic | 2026/09/02 | Not stated by source | CDE |
| 南通联亚药业股份有限公司 | CYHS2601183 | Generic | 2026/05/20 | Not stated by source | CDE |
| 河北龙海药业股份有限公司 | CYHS2601909 | Generic | 2026/08/05 | Not stated by source | CDE |
| 北京华素制药股份有限公司 | CYHS2601665 | Generic | 2026/07/13 | Not stated by source | CDE |
| 兆科药业(广州)有限公司 | CYHS2601349 | Generic | 2026/06/09 | Not stated by source | CDE |
| 兆科药业(广州)有限公司 | CYHS2601348 | Generic | 2026/06/09 | Not stated by source | CDE |
| 中曦(福建)药业有限公司;药大制药有限公司 | CYHS2601039 | Generic | 2026/05/08 | Not stated by source | CDE |
| 中曦(福建)药业有限公司;药大制药有限公司 | CYHS2601038 | Generic | 2026/05/08 | Not stated by source | CDE |
| 沈阳欣瑞制药有限公司 | CYHS2600444 | Generic | 2026/02/11 | Not stated by source | CDE |
| 九华华源药业(桂林)有限公司;华益药业科技(安徽)有限公司 | CYHS2504439 | Generic | 2025/12/27 | Not stated by source | CDE |
| 福州基石医药科技有限公司 | CYHS2503449 | Generic | 2025/09/18 | Not stated by source | CDE |
| 重庆锐恩医药有限公司;植恩生物技术股份有限公司 | CYHS2503145 | Generic | 2025/08/27 | Not stated by source | CDE |
| 重庆锐恩医药有限公司;植恩生物技术股份有限公司 | CYHS2503144 | Generic | 2025/08/27 | Not stated by source | CDE |
| 合肥力成药业有限公司 | CYHS2503001 | Generic | 2025/08/16 | Not stated by source | CDE |
| 北京双鹭药业股份有限公司 | CYHS2502786 | Generic | 2025/08/02 | Not stated by source | CDE |
| 哈尔滨三联药业股份有限公司;兰西哈三联制药有限公司 | CYHS2502782 | Generic | 2025/08/02 | Not stated by source | CDE |
| 华益药业科技(安徽)有限公司 | CYHS2502179 | Generic | 2025/06/18 | Not stated by source | CDE |
| 华益药业科技(安徽)有限公司 | CYHS2502178 | Generic | 2025/06/18 | Not stated by source | CDE |
Loaded records: 11 filings and 8 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 重庆世森医药科技有限公司;烟台鲁银药业有限公司 | CYHS2600176 | Generic | 2026/01/14 | Not stated by source | CDE |
| 南京海纳制药有限公司 | CYHS2602191 | Generic | 2026/09/02 | Not stated by source | CDE |
| 南京海纳制药有限公司 | CYHS2602190 | Generic | 2026/09/02 | Not stated by source | CDE |
| 南通联亚药业股份有限公司 | CYHS2601183 | Generic | 2026/05/20 | Not stated by source | CDE |
| 河北龙海药业股份有限公司 | CYHS2601909 | Generic | 2026/08/05 | Not stated by source | CDE |
| 北京华素制药股份有限公司 | CYHS2601665 | Generic | 2026/07/13 | Not stated by source | CDE |
| 兆科药业(广州)有限公司 | CYHS2601349 | Generic | 2026/06/09 | Not stated by source | CDE |
| 兆科药业(广州)有限公司 | CYHS2601348 | Generic | 2026/06/09 | Not stated by source | CDE |
| 中曦(福建)药业有限公司;药大制药有限公司 | CYHS2601039 | Generic | 2026/05/08 | Not stated by source | CDE |
| 中曦(福建)药业有限公司;药大制药有限公司 | CYHS2601038 | Generic | 2026/05/08 | Not stated by source | CDE |
| 沈阳欣瑞制药有限公司 | CYHS2600444 | Generic | 2026/02/11 | Not stated by source | CDE |
Non-component matches: 8 companies with A status and 8 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 |
|---|---|---|---|---|---|---|
| 盐酸曲唑酮 | 合肥立方制药股份有限公司 | Y20260000741 | I | Exact ingredient | 2026/08/21 | CDE |
| 盐酸曲唑酮 | 河北广祥制药有限公司 | Y20260000137 | I | Exact ingredient | 2026/03/03 | CDE |
| 盐酸曲唑酮 | 山东安信制药有限公司 | Y20250000875 | I | Exact ingredient | 2025/11/04 | CDE |
| 盐酸曲唑酮 | 兰西哈三联制药有限公司 | Y20250000868 | I | Exact ingredient | 2025/08/26 | CDE |
| 盐酸曲唑酮 | 植恩生物技术股份有限公司 | Y20250000281 | I | Exact ingredient | 2025/03/26 | CDE |
| 盐酸曲唑酮 | Granules India Limited.Unit-Ⅳ | Y20240001042 | I | Exact ingredient | 2024/11/18 | CDE |
| 盐酸曲唑酮 | Arene Life Sciences Private Limited | Y20240000118 | I | Exact ingredient | 2024/07/31 | CDE |
| 盐酸曲唑酮 | 四川仁安药业有限责任公司 | Y20240000132 | A | Exact ingredient | 2026/09/12 | CDE |
| 盐酸曲唑酮 | 湖南九典宏阳制药有限公司 | Y20230001003 | A | Exact ingredient | 2026/06/02 | CDE |
| 盐酸曲唑酮 | Medilux Laboratories Pvt. Ltd. | Y20220000900 | A | Exact ingredient | 2026/09/16 | CDE |
| 盐酸曲唑酮 | AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO ACRAF SPA | Y20220000333 | A | Exact ingredient | 2025/09/15 | CDE |
| 盐酸曲唑酮 | Matrix Pharmacorp Private Limited | Y20210000921 | A | Exact ingredient | 2026/09/16 | CDE |
| 盐酸曲唑酮 | Piramal Pharma Limited | Y20210000635 | A | Exact ingredient | 2023/08/14 | CDE |
| 盐酸曲唑酮 | 常州华生制药有限公司 | Y20190004670 | A | Exact ingredient | 2025/07/24 | CDE |
| 盐酸曲唑酮 | 沈阳福宁药业有限公司 | Y20190002723 | A | Exact ingredient | 2024/07/03 | CDE |
| 盐酸曲唑酮 | 浙江华海药业股份有限公司 | Y20260000948 | I | Exact ingredient | 2026/11/09 | 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.
CYHS2502426 · 国药准字H20266455
Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.
View source · Table row 91 ↗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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