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依折麦布阿托伐他汀钙片(II)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 1 applicationNo longer listed under review: 1 applicationNotification delivery: 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 holders8View records ↓
Under-review filings12View records ↓
This year’s generic filers3View records ↓
NHSA approval numbers8View records ↓
API companies with A status0View records ↓
Chemical-drug catalogue
Loaded records: 8 holders; 0 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 |
|---|---|---|---|---|---|---|
| 华润赛科药业有限责任公司 | 华润赛科药业有限责任公司 | 国药准字H20265907 | 2026/09/08 | 每片含依折麦布10mg与阿托伐他汀钙20mg (按C33H35FN2O5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 |
| 湖北民康药业集团有限公司 | 南京海纳制药有限公司 | 国药准字H20265482 | 2026/08/04 | 每片含依折麦布10mg与阿托伐他汀钙20mg（按C33H35FN2O5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 |
| 重庆圣华曦药业股份有限公司 | 重庆圣华曦药业股份有限公司 | 国药准字H20264559 | 2026/05/27 | 每片含依折麦布10mg与阿托伐他汀钙20mg（按C33H35FN2O5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 |
| 乐普制药科技有限公司 | 乐普制药科技有限公司 | 国药准字H20256420 | 2025/12/30 | 每片含依折麦布10mg与阿托伐他汀钙20mg（按C33H35FN2O5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 |
| 成都倍特药业股份有限公司 | 成都倍特药业股份有限公司 | 国药准字H20255179 | 2025/08/19 | 每片含依折麦布10mg与阿托伐他汀钙20mg（以C33H35FN2O5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 |
| 北京福元医药股份有限公司 | 北京福元医药股份有限公司 | 国药准字H20253380 | 2025/02/11 | 每片含依折麦布10mg与阿托伐他汀钙20mg（按C33H35FN2O5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 |
| 江苏诺泰澳赛诺生物制药股份有限公司 | 江西施美药业股份有限公司 | 国药准字H20253267 | 2025/01/24 | 每片含依折麦布10mg和阿托伐他汀钙20mg（以阿托伐他汀计） | 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 |
| 浙江花园药业有限公司 | 浙江花园药业有限公司 | 国药准字H20266075 | 2026/09/22 | 每片含依折麦布10mg与阿托伐他汀钙20mg（按C33H35FN2O5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 |
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: 8 distinct approval numbers and 8 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 成都倍特药业股份有限公司 | 国药准字H20255179 | 每片含依折麦布10mg与阿托伐他汀钙20mg(以C₃₃H₃₅FN₂O₅计) | Category B (乙) | XC10BAY348A001010102013 | NHSA |
| 重庆圣华曦药业股份有限公司 | 国药准字H20264559 | 每片含依折麦布10mg与阿托伐他汀钙20mg(按C₃₃H₃₅FN₂O₅计) | Category B (乙) | XC10BAY348A001010109568 | NHSA |
| 成都倍特药业股份有限公司 | 国药准字H20255179 | 每片含依折麦布10mg与阿托伐他汀钙20mg(以C₃₃H₃₅FN₂O₅计) | Category B (乙) | XC10BAY348A001010202013 | NHSA |
| 重庆圣华曦药业股份有限公司 | 国药准字H20264559 | 每片含依折麦布10mg与阿托伐他汀钙20mg(按C₃₃H₃₅FN₂O₅计) | Category B (乙) | XC10BAY348A001010209568 | NHSA |
| 华润赛科药业有限责任公司 | 国药准字H20265907 | 每片含依折麦布10mg与阿托伐他汀钙20mg (按C₃₃H₃₅FN₂O₅计) | Category B (乙) | XC10BAY348A001010100111 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20253380 | 每片含依折麦布10mg与阿托伐他汀钙20mg(按C₃₃H₃₅FN₂O₅计) | Category B (乙) | XC10BAY348A001010100177 | NHSA |
| N.V. Organon | 国药准字HJ20230110 | 每片含依折麦布10mg与阿托伐他汀钙20mg(按C₃₃H₃₅ | Category B (乙) | XC10BAY348A001010179034 | NHSA |
| 江苏诺泰澳赛诺生物制药股份有限公司 | 国药准字H20253267 | 每片含依折麦布10mg与阿托伐他汀钙20mg(以阿托伐他汀计) | Category B (乙) | XC10BAY348A001010180539 | NHSA |
| 乐普制药科技有限公司 | 国药准字H20256420 | 每片含依折麦布10mg与阿托伐他汀钙20mg(按C₃₃H₃₅FN₂O₅计) | Category B (乙) | XC10BAY348A001010182919 | NHSA |
| 湖北民康药业集团有限公司 | 国药准字H20265482 | 每片含依折麦布10mg与阿托伐他汀钙20mg(按C₃₃H₃₅FN₂O₅计) | Category B (乙) | XC10BAY348A001010184564 | NHSA |
| 华润赛科药业有限责任公司 | 国药准字H20265907 | 每片含依折麦布10mg与阿托伐他汀钙20mg (按C₃₃H₃₅FN₂O₅计) | Category B (乙) | XC10BAY348A001010200111 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20253380 | 每片含依折麦布10mg与阿托伐他汀钙20mg(按C₃₃H₃₅FN₂O₅计) | Category B (乙) | XC10BAY348A001010200177 | NHSA |
| N.V. Organon | 国药准字HJ20230110 | 每片含依折麦布10mg与阿托伐他汀钙20mg(按C₃₃H₃₅ | Category B (乙) | XC10BAY348A001010279034 | NHSA |
| 江苏诺泰澳赛诺生物制药股份有限公司 | 国药准字H20253267 | 每片含依折麦布10mg与阿托伐他汀钙20mg(以阿托伐他汀计) | Category B (乙) | XC10BAY348A001010280539 | NHSA |
| 乐普制药科技有限公司 | 国药准字H20256420 | 每片含依折麦布10mg与阿托伐他汀钙20mg(按C₃₃H₃₅FN₂O₅计) | Category B (乙) | XC10BAY348A001010282919 | NHSA |
| 湖北民康药业集团有限公司 | 国药准字H20265482 | 每片含依折麦布10mg与阿托伐他汀钙20mg(按C₃₃H₃₅FN₂O₅计) | Category B (乙) | XC10BAY348A001010284564 | NHSA |
| 华润赛科药业有限责任公司 | 国药准字H20265907 | 每片含依折麦布10mg与阿托伐他汀钙20mg (按C₃₃H₃₅FN₂O₅计) | Category B (乙) | XC10BAY348A001010300111 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20253380 | 每片含依折麦布10mg与阿托伐他汀钙20mg(按C₃₃H₃₅FN₂O₅计) | Category B (乙) | XC10BAY348A001010300177 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20253380 | 每片含依折麦布10mg与阿托伐他汀钙20mg(按C₃₃H₃₅FN₂O₅计) | Category B (乙) | XC10BAY348A001010400177 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20253380 | 每片含依折麦布10mg与阿托伐他汀钙20mg(按C₃₃H₃₅FN₂O₅计) | Category B (乙) | XC10BAY348A001010500177 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20253380 | 每片含依折麦布10mg与阿托伐他汀钙20mg(按C₃₃H₃₅FN₂O₅计) | Category B (乙) | XC10BAY348A001010600177 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20253380 | 每片含依折麦布10mg与阿托伐他汀钙20mg(按C₃₃H₃₅FN₂O₅计) | Category B (乙) | XC10BAY348A001010700177 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20253380 | 每片含依折麦布10mg与阿托伐他汀钙20mg(按C₃₃H₃₅FN₂O₅计) | Category B (乙) | XC10BAY348A001010800177 | 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: 12 filings and 12 distinct first applicants.
Generic 11 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 湖北午时药业股份有限公司 | CYHS2500653 | Generic | 2025/02/09 | Not stated by source | CDE |
| 浙江普洛康裕制药有限公司 | CYHS2600574 | Generic | 2026/02/28 | Not stated by source | CDE |
| 浙江江北药业有限公司 | CYHS2503643 | Generic | 2025/10/14 | Not stated by source | CDE |
| 江苏康缘药业股份有限公司 | CYHS2503814 | Generic | 2025/10/28 | Not stated by source | CDE |
| N.V. Organon;MSD International GmbH (Puerto Rico Branch) LLC（压片、包衣）;MSD International GmbH (Singapore Branch）（制粒、压片、包衣） | JYHB2600493 | Supplement | 2026/08/27 | Not stated by source | CDE |
| 浙江康德药业集团股份有限公司 | CYHS2600866 | Generic | 2026/04/15 | Not stated by source | CDE |
| 昆明积大制药股份有限公司 | CYHS2600201 | Generic | 2026/01/16 | Not stated by source | CDE |
| 浙江昂利康制药股份有限公司 | CYHS2504495 | Generic | 2025/12/31 | Not stated by source | CDE |
| 成都康泰源医药科技有限责任公司;广州市联瑞制药有限公司 | CYHS2504382 | Generic | 2025/12/25 | Not stated by source | CDE |
| 湖南方盛制药股份有限公司 | CYHS2503531 | Generic | 2025/09/28 | Not stated by source | CDE |
| 成都地奥九泓制药厂;地奥集团成都药业股份有限公司 | CYHS2503527 | Generic | 2025/09/28 | Not stated by source | CDE |
| 湖南先施制药有限公司 | CYHS2503368 | Generic | 2025/09/11 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 3 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 浙江普洛康裕制药有限公司 | CYHS2600574 | Generic | 2026/02/28 | Not stated by source | CDE |
| 浙江康德药业集团股份有限公司 | CYHS2600866 | Generic | 2026/04/15 | Not stated by source | CDE |
| 昆明积大制药股份有限公司 | CYHS2600201 | Generic | 2026/01/16 | Not stated by source | CDE |
API registrations
Non-component matches: 0 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 |
|---|---|---|---|---|---|---|
| No matching records were found in the currently loaded source data; coverage dates are listed below. | ||||||
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.
-
2026/10/31No longer listed under review
N.V. Organon;MSD International GmbH (Puerto Rico Branch) LLC（压片、包衣）;MSD International GmbH (Singapore Branch）（制粒、压片、包衣）
JYHB2500642
Fact date: 2026/10/31 · Site observation date: 2026/10/31
Accepted: 2025/11/27
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/30Notification delivery
欧加隆（上海）医药科技有限公司，N.V. Organon
JYHB2500642
Fact date: 2026/10/30 (Publication date) · Publication date: 2026/10/30 · Site observation date: 2026/11/03
Notification delivered; the specific outcome remains to be checked.
View source · Table row 5 ↗ -
2026/08/27Accepted
N.V. Organon;MSD International GmbH (Puerto Rico Branch) LLC（压片、包衣）;MSD International GmbH (Singapore Branch）（制粒、压片、包衣）
JYHB2600493
Fact date: 2026/08/27 · Site observation date: 2026/10/22
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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