Monthly
US$200
Billed every month
Omega-3-acid ethyl ester 90 Soft Capsules(ω-3脂肪酸乙酯90软胶囊)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 3 applications
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 holders12View records ↓
Under-review filings11View records ↓
This year’s generic filers5View records ↓
NHSA approval numbers11View records ↓
API companies with A status3View records ↓
Chemical-drug catalogue
Loaded records: 12 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 10 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 |
|---|---|---|---|---|---|---|
| 海南全星制药有限公司 | 海南海神同洲制药有限公司 | 国药准字H20265690 | 2026/08/25 | 1g（每粒胶囊含二十碳五烯酸乙酯465mg，二十二碳六烯酸乙酯375mg，ω-3脂肪酸乙酯总量不低于900mg） | 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 |
| 瑞阳制药股份有限公司 | 瑞阳制药股份有限公司 | 国药准字H20265256 | 2026/07/21 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg，二十二碳六烯酸乙酯375mg，ω-3脂肪酸乙酯总量不低于900mg) | 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 |
| 大连美创药业有限公司 | 大连美创药业有限公司 | 国药准字H20265053 | 2026/06/30 | 1g（每粒胶囊含二十碳五烯酸乙酯465mg，二十二碳六烯酸乙酯375mg，ω-3脂肪酸乙酯总量不低于900mg） | 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 |
| 北京双鹭药业股份有限公司 | 北京双鹭药业股份有限公司 | 国药准字H20264179 | 2026/04/29 | 1g（每粒胶囊含二十碳五烯酸乙酯465mg，二十二碳六烯酸乙酯375mg，ω-3脂肪酸乙酯总量不低于900mg） | 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 |
| 山西鑫煜制药股份有限公司 | 大连美创药业有限公司 | 国药准字H20264070 | 2026/04/21 | 1g(每粒胶囊含二十碳五烯酸乙酯 465mg，二十二碳六烯酸乙酯375mg， ω-3脂肪酸乙酯总量不低于900mg) | 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 | 浙江医药股份有限公司新昌制药厂 | 国药准字H20254846 | 2025/07/15 | 1g（含二十碳五烯酸乙酯465mg，二十二碳六烯酸乙酯375mg，ω-3脂肪酸乙酯总量不低于900mg） | Not stated by source | 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H20249504 | 2024/12/01 | 1g（每粒胶囊含二十碳五烯酸乙酯 465mg，二十二碳六烯酸乙酯375mg， ω-3脂肪酸乙酯总量不低于900mg） | 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H20244905 | 2024/09/19 | 1g（含二十碳五烯酸乙酯465mg，二十二碳六烯酸乙酯375mg，ω-3脂肪酸乙酯总量不低于900mg） | 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H20244779 | 2024/09/03 | 1g（每粒胶囊含二十碳五烯酸乙酯465mg，二十二碳六烯酸乙酯375mg，ω-3脂肪酸乙酯总量不低于900mg） | 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H20244572 | 2024/07/30 | 1g（每粒胶囊含二十碳五烯酸乙酯465mg，二十二碳六烯酸乙酯375mg，ω-3脂肪酸乙酯总量不低于900mg）。 | Not stated by source | 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H20223269 | 2022/04/29 | 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 |
| 四川国为制药有限公司 | 四川国为制药有限公司 | 国药准字H20213547 | 2021/06/22 | 1g（含二十碳五烯酸乙酯465mg，二十二碳六烯酸乙酯375mg，ω-3脂肪酸乙酯总量不低于900mg） | 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: 11 distinct approval numbers and 11 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 北京双鹭药业股份有限公司 | 国药准字H20264179 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙酯375mg,ω-3脂肪酸乙酯总量不低于900mg) | Not stated by source | XC10AXU011E002010100148 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20244905 | 1g(含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙酯375mg,ω-3 | Not stated by source | XC10AXU011E002010101503 | NHSA |
| 扬子江药业集团有限公司 | 国药准字H20249504 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙 | Not stated by source | XC10AXU011E002010101749 | NHSA |
| 山西鑫煜制药股份有限公司 | 国药准字H20264070 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙酯375mg,ω-3脂肪酸乙酯总量不低于900mg) | Not stated by source | XC10AXU011E002010102957 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20244779 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙 | Not stated by source | XC10AXU011E002010104021 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20265256 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙酯375mg,ω-3脂肪酸乙酯总量不少于900mg) | Not stated by source | XC10AXU011E002010104152 | NHSA |
| 海南全星制药有限公司 | 国药准字H20265690 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙酯375mg,ω-3脂肪酸乙酯总量不低于900mg) | Not stated by source | XC10AXU011E002010105765 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20244572 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙 | Not stated by source | XC10AXU011E002010109981 | NHSA |
| 成都盛迪医药有限公司 | 国药准字H20223269 | 1g(含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙酯375mg,ω-3 | Not stated by source | XC10AXU011E002010180435 | NHSA |
| ABBOTT LABORATORIES LIMITED | 国药准字HJ20220042 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙 | Not stated by source | XC10AXU011E002010180487 | NHSA |
| 四川国为制药有限公司 | 国药准字H20213547 | 1g(含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙酯375mg,ω-3 | Not stated by source | XC10AXU011E002010180937 | NHSA |
| 北京双鹭药业股份有限公司 | 国药准字H20264179 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙酯375mg,ω-3脂肪酸乙酯总量不低于900mg) | Not stated by source | XC10AXU011E002010200148 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20244905 | 1g(含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙酯375mg,ω-3 | Not stated by source | XC10AXU011E002010201503 | NHSA |
| 扬子江药业集团有限公司 | 国药准字H20249504 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙 | Not stated by source | XC10AXU011E002010201749 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20244779 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙 | Not stated by source | XC10AXU011E002010204021 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20244572 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙 | Not stated by source | XC10AXU011E002010209981 | NHSA |
| 成都盛迪医药有限公司 | 国药准字H20223269 | 1g(含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙酯375mg,ω-3 | Not stated by source | XC10AXU011E002010280435 | NHSA |
| 四川国为制药有限公司 | 国药准字H20213547 | 1g(含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙酯375mg,ω-3 | Not stated by source | XC10AXU011E002010280937 | NHSA |
| 北京双鹭药业股份有限公司 | 国药准字H20264179 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙酯375mg,ω-3脂肪酸乙酯总量不低于900mg) | Not stated by source | XC10AXU011E002010300148 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20244905 | 1g(含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙酯375mg,ω-3 | Not stated by source | XC10AXU011E002010301503 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20244572 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙 | Not stated by source | XC10AXU011E002010309981 | NHSA |
| 四川国为制药有限公司 | 国药准字H20213547 | 1g(含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙酯375mg,ω-3 | Not stated by source | XC10AXU011E002010380937 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20244905 | 1g(含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙酯375mg,ω-3 | Not stated by source | XC10AXU011E002010401503 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20244572 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙 | Not stated by source | XC10AXU011E002010409981 | NHSA |
| 四川国为制药有限公司 | 国药准字H20213547 | 1g(含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙酯375mg,ω-3 | Not stated by source | XC10AXU011E002010480937 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20244905 | 1g(含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙酯375mg,ω-3 | Not stated by source | XC10AXU011E002010501503 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20244572 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙 | Not stated by source | XC10AXU011E002010509981 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20244905 | 1g(含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙酯375mg,ω-3 | Not stated by source | XC10AXU011E002010601503 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20244572 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙 | Not stated by source | XC10AXU011E002010609981 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20244905 | 1g(含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙酯375mg,ω-3 | Not stated by source | XC10AXU011E002010701503 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20244572 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙 | Not stated by source | XC10AXU011E002010709981 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20244572 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙 | Not stated by source | XC10AXU011E002010809981 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20244572 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙 | Not stated by source | XC10AXU011E002010909981 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20244572 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙 | Not stated by source | XC10AXU011E002011009981 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20244572 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙 | Not stated by source | XC10AXU011E002011109981 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20244572 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙 | Not stated by source | XC10AXU011E002011209981 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20244572 | 1g(每粒胶囊含二十碳五烯酸乙酯465mg,二十二碳六烯酸乙 | Not stated by source | XC10AXU011E002011309981 | 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: 11 filings and 11 distinct first applicants.
Generic 9 · Import re-registration 1 · Import 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 | CYHS2600961 | Generic | 2026/04/25 | Not stated by source | CDE |
| ABBOTT LABORATORIES LIMITED;PATHEON SOFTGELS B.V.;Shanghai Abbott Pharmaceutical Co. Ltd. | JYHZ2600223 | Import re-registration | 2026/09/16 | Not stated by source | CDE |
| 海南万玮制药有限公司 | CYHS2602150 | Generic | 2026/08/28 | 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 | CYHS2601216 | Generic | 2026/06/01 | Not stated by source | CDE |
| 浙江亚峰药厂有限公司 | CYHS2601113 | Generic | 2026/05/13 | Not stated by source | CDE |
| 江西普正制药股份有限公司;大连美创药业有限公司 | CYHS2503246 | Generic | 2025/09/03 | Not stated by source | CDE |
| 海南斯达制药有限公司 | CYHS2502765 | Generic | 2025/08/01 | Not stated by source | CDE |
| 青岛双鲸药业股份有限公司 | CYHS2502736 | Generic | 2025/07/30 | Not stated by source | CDE |
| 丽珠集团丽珠制药厂 | CYHS2502581 | Generic | 2025/07/18 | Not stated by source | CDE |
| Strides Pharma Global Pte Limited;STRIDES PHARMA SCIENCE LIMITED;Hainan Sihuan Pharmaceutical Co. Ltd | JYHS2300036 | Import | 2023/03/10 | Not stated by source | CDE |
| 温州海鹤药业有限公司 | CYHS2602659 | 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 |
|---|---|---|---|---|---|
| 山东禾琦制药有限公司;烟台鲁银药业有限公司 | CYHS2600961 | Generic | 2026/04/25 | Not stated by source | CDE |
| 海南万玮制药有限公司 | CYHS2602150 | Generic | 2026/08/28 | 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 | CYHS2601216 | Generic | 2026/06/01 | Not stated by source | CDE |
| 浙江亚峰药厂有限公司 | CYHS2601113 | Generic | 2026/05/13 | Not stated by source | CDE |
| 温州海鹤药业有限公司 | CYHS2602659 | Generic | 2026/10/30 | Not stated by source | CDE |
API registrations
Non-component matches: 3 companies with A status and 4 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 |
|---|---|---|---|---|---|---|
| ω-3脂肪酸乙酯 90 | 山东新华制药股份有限公司 | Y20250001501 | I | Exact ingredient | 2026/02/26 | CDE |
| ω-3脂肪酸乙酯90 | 湖北葛店人福药用辅料有限责任公司 | Y20250001264 | I | Exact ingredient | 2025/12/25 | CDE |
| ω-3脂肪酸乙酯90 | 四川欣美加生物医药股份有限公司 | Y20240001165 | I | Exact ingredient | 2024/12/13 | CDE |
| ω-3脂肪酸乙酯90 | 四川国为制药有限公司 | Y20190001013 | A | Exact ingredient | 2026/01/09 | CDE |
| ω-3脂肪酸乙酯90 | BASF AS | Y20180001358 | A | Exact ingredient | 2024/09/14 | CDE |
| ω-3脂肪酸乙酯90 | 德阳欧博生物技术有限公司 | Y20190000382 | A | Exact ingredient | 2025/05/17 | CDE |
| ω-3脂肪酸乙酯90 | K.D. Pharma Bexbach GmbH | Y20180000188 | I | Exact ingredient | 2023/05/10 | 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.
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2026/10/30Accepted
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2026/09/16Accepted
ABBOTT LABORATORIES LIMITED;PATHEON SOFTGELS B.V.;Shanghai Abbott Pharmaceutical Co. Ltd.
JYHZ2600223
Fact date: 2026/09/16 · Site observation date: 2026/10/22
View source ↗ -
2026/08/28Accepted
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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