Monthly
US$200
Billed every month
Ethyl Iosapentate Capsules(二十碳五烯酸乙酯软胶囊)
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 2 applicationsNo longer listed under review: 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 holders16View records ↓
Under-review filings25View records ↓
This year’s generic filers8View records ↓
NHSA approval numbers16View records ↓
API companies with A status5View records ↓
Chemical-drug catalogue
Loaded records: 16 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 15 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 |
|---|---|---|---|---|---|---|
| 北京诚济制药股份有限公司 | 人福普克药业（武汉）有限公司 | 国药准字H20265933 | 2026/09/15 | 1.0g | 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 |
| 浙江创新生物有限公司 | 浙江创新生物有限公司 | 国药准字H20265600 | 2026/08/04 | 1.0g | 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 |
| 北京民康百草医药科技有限公司 | 大连美创药业有限公司 | 国药准字H20264795 | 2026/06/17 | 1.0g | 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 |
| 桂林南药股份有限公司 | 桂林南药股份有限公司 | 国药准字H20264546 | 2026/05/27 | 1.0g | 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H20263744 | 2026/03/31 | 1.0g | 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 |
| 浙江爱生药业有限公司 | 浙江爱生药业有限公司 | 国药准字H20263651 | 2026/03/17 | 1.0g | 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 |
| 杭州中美华东制药有限公司 | 杭州中美华东制药有限公司 | 国药准字H20256145 | 2025/12/03 | 1.0g | Not stated by source | CDE |
| 杭州中美华东制药有限公司 | 杭州中美华东制药有限公司 | 国药准字H20256155 | 2025/12/03 | 0.5g | 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 |
| 成都盛迪医药有限公司 | 成都盛迪医药有限公司 | 国药准字H20255271 | 2025/09/02 | 1.0g | 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 |
| 成都盛迪医药有限公司 | 成都盛迪医药有限公司 | 国药准字H20255270 | 2025/09/02 | 0.5g | 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 |
| 浙江诚意药业股份有限公司 | 浙江诚意药业股份有限公司 | 国药准字H20255236 | 2025/08/26 | 0.5g | 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 |
| 人福普克药业（武汉）有限公司 | 人福普克药业（武汉）有限公司 | 国药准字H20255248 | 2025/08/26 | 1.0g | 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 |
| 浙江诚意药业股份有限公司 | 浙江诚意药业股份有限公司 | 国药准字H20255237 | 2025/08/26 | 1.0g | 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 |
| 人福普克药业（武汉）有限公司 | 人福普克药业（武汉）有限公司 | 国药准字H20255247 | 2025/08/26 | 0.5g | 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 |
| 扬子江药业集团有限公司 | 扬子江药业集团有限公司 | 国药准字H20254982 | 2025/07/29 | 1.0g | 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 |
| 四川科伦药业股份有限公司 | 四川科伦药业股份有限公司 | 国药准字H20254869 | 2025/07/15 | 1.0g | 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 |
| 齐鲁制药有限公司 | 齐鲁制药有限公司 | 国药准字H20254765 | 2025/06/30 | 1.0g | 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 |
| 山东新华制药股份有限公司 | 山东新华制药股份有限公司 | 国药准字H20254286 | 2025/05/27 | 1.0g | 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 |
| 山东新华制药股份有限公司 | 山东新华制药股份有限公司 | 国药准字H20254287 | 2025/05/27 | 0.5g | 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 |
| Amarin Pharmaceuticals Ireland Ltd. | Patheon Softgels B.V. | 国药准字HJ20230058 | 2023/05/29 | 1.0g | Imported originator drug (进口原研药品) | CDE |
| 四川国为制药有限公司 | 四川国为制药有限公司 | 国药准字H20233110 | 2023/01/31 | 1.0g | 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: 16 distinct approval numbers and 13 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H20263744 | 1.0g | Not stated by source | XC10AXE095E002010101503 | NHSA |
| 扬子江药业集团有限公司 | 国药准字H20254982 | 1.0g | Not stated by source | XC10AXE095E002010101749 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20254869 | 1.0g | Not stated by source | XC10AXE095E002010102180 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20254765 | 1.0g | Not stated by source | XC10AXE095E002010104021 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20254286 | 1.0g | Not stated by source | XC10AXE095E002010104187 | NHSA |
| 浙江爱生药业有限公司 | 国药准字H20263651 | 1.0g | Not stated by source | XC10AXE095E002010104604 | NHSA |
| 浙江诚意药业股份有限公司 | 国药准字H20255236 | 0.5g | Not stated by source | XC10AXE095E002010104615 | NHSA |
| 桂林南药股份有限公司 | 国药准字H20264546 | 1.0g | Not stated by source | XC10AXE095E002010105206 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20255247 | 0.5g | Not stated by source | XC10AXE095E002010109981 | NHSA |
| 成都盛迪医药有限公司 | 国药准字H20255270 | 0.5g | Not stated by source | XC10AXE095E002010180435 | NHSA |
| 四川国为制药有限公司 | 国药准字H20233110 | 1.0g | Not stated by source | XC10AXE095E002010180937 | NHSA |
| 北京民康百草医药科技有限公司 | 国药准字H20264795 | 1.0g | Not stated by source | XC10AXE095E002010183644 | NHSA |
| Amarin Pharmaceuticals Ireland Ltd. | 国药准字HJ20230058 | 1.0g | Not stated by source | XC10AXE095E002010184791 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20263744 | 1.0g | Not stated by source | XC10AXE095E002010201503 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20254765 | 1.0g | Not stated by source | XC10AXE095E002010204021 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20254286 | 1.0g | Not stated by source | XC10AXE095E002010204187 | NHSA |
| 浙江爱生药业有限公司 | 国药准字H20263651 | 1.0g | Not stated by source | XC10AXE095E002010204604 | NHSA |
| 浙江诚意药业股份有限公司 | 国药准字H20255236 | 0.5g | Not stated by source | XC10AXE095E002010204615 | NHSA |
| 四川国为制药有限公司 | 国药准字H20233110 | 1.0g | Not stated by source | XC10AXE095E002010280937 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20263744 | 1.0g | Not stated by source | XC10AXE095E002010301503 | NHSA |
| 浙江爱生药业有限公司 | 国药准字H20263651 | 1.0g | Not stated by source | XC10AXE095E002010304604 | NHSA |
| 四川国为制药有限公司 | 国药准字H20233110 | 1.0g | Not stated by source | XC10AXE095E002010380937 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20263744 | 1.0g | Not stated by source | XC10AXE095E002010401503 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20263744 | 1.0g | Not stated by source | XC10AXE095E002010501503 | NHSA |
| 浙江诚意药业股份有限公司 | 国药准字H20255237 | 1.0g | Not stated by source | XC10AXE095E002020104615 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20255248 | 1.0g | Not stated by source | XC10AXE095E002020109981 | NHSA |
| 成都盛迪医药有限公司 | 国药准字H20255271 | 1.0g | Not stated by source | XC10AXE095E002020180435 | NHSA |
| 浙江诚意药业股份有限公司 | 国药准字H20255237 | 1.0g | Not stated by source | XC10AXE095E002020204615 | 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: 25 filings and 21 distinct first applicants.
Generic 24 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 山东禾琦制药有限公司;烟台鲁银药业有限公司 | CYHS2600959 | Generic | 2026/04/24 | Not stated by source | CDE |
| 江苏联环药业股份有限公司;江苏万高药业股份有限公司 | CYHS2601680 | Generic | 2026/07/15 | Not stated by source | CDE |
| 江苏联环药业股份有限公司;江苏万高药业股份有限公司 | CYHS2601679 | Generic | 2026/07/15 | Not stated by source | CDE |
| 博瑞制药（苏州）有限公司 | CYHS2501609 | Generic | 2025/04/29 | Not stated by source | CDE |
| 博瑞制药（苏州）有限公司 | CYHS2404522 | Generic | 2024/12/26 | Not stated by source | CDE |
| 河南君善生物技术有限公司;南京海鲸药业股份有限公司 | CYHS2601271 | Generic | 2026/06/04 | Not stated by source | CDE |
| 河南君善生物技术有限公司;南京海鲸药业股份有限公司 | CYHS2601270 | Generic | 2026/06/04 | Not stated by source | CDE |
| 常州四药制药有限公司;南通华山药业有限公司 | CYHS2602258 | Generic | 2026/09/10 | Not stated by source | CDE |
| 苏州中化药品工业有限公司;南通华山药业有限公司 | CYHS2502215 | Generic | 2025/06/20 | Not stated by source | CDE |
| 苏州中化药品工业有限公司;南通华山药业有限公司 | CYHS2502214 | Generic | 2025/06/20 | Not stated by source | CDE |
| 湖南润兴药业有限公司;湖南先施制药有限公司 | CYHS2602361 | Generic | 2026/09/21 | Not stated by source | CDE |
| 浙江赛默制药有限公司 | CYHS2601667 | Generic | 2026/07/13 | Not stated by source | CDE |
| Amarin Pharmaceuticals Ireland Ltd.;Patheon Softgels B.V. | JYHB2600373 | Supplement | 2026/07/08 | Not stated by source | CDE |
| 浙江浙北药业有限公司 | CYHS2601563 | Generic | 2026/07/02 | Not stated by source | CDE |
| 浙江华海药业股份有限公司 | CYHS2600705 | Generic | 2026/03/24 | Not stated by source | CDE |
| 四川宏明博思药业有限公司;大连美创药业有限公司 | CYHS2504105 | Generic | 2025/11/28 | Not stated by source | CDE |
| 成都诺和晟鸿生物制药有限公司;大连美创药业有限公司 | CYHS2503671 | Generic | 2025/10/14 | Not stated by source | CDE |
| 山东益康药业股份有限公司 | CYHS2503101 | Generic | 2025/08/23 | Not stated by source | CDE |
| 华北制药股份有限公司 | CYHS2502483 | Generic | 2025/07/12 | Not stated by source | CDE |
| 浙江沣华医药科技有限公司;浙江四维医药科技有限公司 | CYHS2502243 | Generic | 2025/06/21 | Not stated by source | CDE |
| 海南斯达制药有限公司 | CYHS2502217 | Generic | 2025/06/20 | Not stated by source | CDE |
| 沐邦（北京）医药科技有限公司;天津市中央药业有限公司 | CYHS2502103 | Generic | 2025/06/12 | Not stated by source | CDE |
| 北京斯利安药业有限公司 | CYHS2501995 | Generic | 2025/06/05 | Not stated by source | CDE |
| 安徽威尔曼制药有限公司 | CYHS2501837 | Generic | 2025/05/21 | Not stated by source | CDE |
| 海南全星制药有限公司;海南海神同洲制药有限公司 | CYHS2500154 | Generic | 2025/01/09 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 10 filings and 8 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 山东禾琦制药有限公司;烟台鲁银药业有限公司 | CYHS2600959 | Generic | 2026/04/24 | Not stated by source | CDE |
| 江苏联环药业股份有限公司;江苏万高药业股份有限公司 | CYHS2601680 | Generic | 2026/07/15 | Not stated by source | CDE |
| 江苏联环药业股份有限公司;江苏万高药业股份有限公司 | CYHS2601679 | Generic | 2026/07/15 | Not stated by source | CDE |
| 河南君善生物技术有限公司;南京海鲸药业股份有限公司 | CYHS2601271 | Generic | 2026/06/04 | Not stated by source | CDE |
| 河南君善生物技术有限公司;南京海鲸药业股份有限公司 | CYHS2601270 | Generic | 2026/06/04 | Not stated by source | CDE |
| 常州四药制药有限公司;南通华山药业有限公司 | CYHS2602258 | Generic | 2026/09/10 | Not stated by source | CDE |
| 湖南润兴药业有限公司;湖南先施制药有限公司 | CYHS2602361 | Generic | 2026/09/21 | Not stated by source | CDE |
| 浙江赛默制药有限公司 | CYHS2601667 | Generic | 2026/07/13 | Not stated by source | CDE |
| 浙江浙北药业有限公司 | CYHS2601563 | Generic | 2026/07/02 | Not stated by source | CDE |
| 浙江华海药业股份有限公司 | CYHS2600705 | Generic | 2026/03/24 | Not stated by source | CDE |
API registrations
Non-component matches: 5 companies with A status and 3 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 |
|---|---|---|---|---|---|---|
| 二十碳五烯酸乙酯 | Nissui Corporation | Y20250001446 | I | Exact ingredient | 2026/06/22 | CDE |
| 二十碳五烯酸乙酯 | 四川国为制药有限公司 | Y20250000130 | A | Exact ingredient | 2026/06/24 | CDE |
| 二十碳五烯酸乙酯 | 中化合成生技股份有限公司山佳工厰 | Y20240000341 | I | Exact ingredient | 2024/07/11 | CDE |
| 二十碳五烯酸乙酯 | 山东新华制药股份有限公司 | Y20230000457 | A | Exact ingredient | 2025/05/15 | CDE |
| 二十碳五烯酸乙酯 | BASF AS | Y20210001175 | A | Exact ingredient | 2026/02/04 | CDE |
| 二十碳五烯酸乙酯 | 山东新华制药股份有限公司 | Y20210001073 | I | Exact ingredient | 2022/08/03 | CDE |
| 二十碳五烯酸乙酯 | 四川国为制药有限公司 | Y20210000213 | A | Exact ingredient | 2023/02/07 | CDE |
| 二十碳五烯酸乙酯 | NISSHIN PHARMA INC. | Y20200001451 | A | Exact ingredient | 2025/09/13 | CDE |
| 二十碳五烯酸乙酯 | Chemport Inc. | Y20180000121 | A | Exact ingredient | 2026/10/25 | 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.
-
2026/11/03Marketing application approved
甘正（海南）生物药业有限公司
CYHS2404317 · 国药准字H20266434
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 13 ↗ -
2026/10/28No longer listed under review
北京康立生医药技术开发有限公司;安徽悦博生物制药有限公司
CYHS2502040
Fact date: 2026/10/28 · Site observation date: 2026/10/28
Accepted: 2025/06/10
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/09/21Accepted
湖南润兴药业有限公司;湖南先施制药有限公司
CYHS2602361
Fact date: 2026/09/21 · Site observation date: 2026/10/22
View source ↗ -
2026/09/10Accepted
常州四药制药有限公司;南通华山药业有限公司
CYHS2602258
Fact date: 2026/09/10 · Site observation date: 2026/10/21
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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