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Sign in to subscribeOmega-3-acid ethyl ester 90 Soft Capsules
As of 13 November 2026, for Omega-3-acid ethyl ester 90 Soft Capsules, 11 applications are listed as under review at China's CDE; 5 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 12 holders.
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.
Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.
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 |
|---|---|---|---|---|---|---|
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H20265690 | 2026/08/25 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Rui Yang Pharmaceutical Co., Ltd. romanized | Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20265256 | 2026/07/21 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Da Lian Mei Chuang Pharma Co., Ltd. romanized | Da Lian Mei Chuang Pharma Co., Ltd. romanized | 国药准字H20265053 | 2026/06/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing SL Pharmaceutical Co., Ltd. | Beijing SL Pharmaceutical Co., Ltd. | 国药准字H20264179 | 2026/04/29 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shanxi Xin Yu Pharmaceutical Co., Ltd. romanized | Da Lian Mei Chuang Pharma Co., Ltd. romanized | 国药准字H20264070 | 2026/04/21 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Innovation Bio Co., Ltd. romanized | Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized | 国药准字H20254846 | 2025/07/15 | See source | Not stated by source | CDE |
| Yangtze River Pharmaceutical Group Co., Ltd | Yangtze River Pharmaceutical Group Co., Ltd | 国药准字H20249504 | 2024/12/01 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20244905 | 2024/09/19 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. | 国药准字H20244779 | 2024/09/03 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20244572 | 2024/07/30 | See source | Not stated by source | CDE |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H20223269 | 2022/04/29 | 1g | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Gowell Pharmaceutical Co., Ltd. | Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20213547 | 2021/06/22 | See source | Generic approved under the new chemical-drug registration classification | 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 |
|---|---|---|---|---|---|
| Beijing SL Pharmaceutical Co., Ltd. | 国药准字H20264179 | See source | Not stated by source | XC10AXU011E002010100148 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20244905 | See source | Not stated by source | XC10AXU011E002010101503 | NHSA |
| Yangtze River Pharmaceutical Group Co., Ltd | 国药准字H20249504 | See source | Not stated by source | XC10AXU011E002010101749 | NHSA |
| Shanxi Xin Yu Pharmaceutical Co., Ltd. romanized | 国药准字H20264070 | See source | Not stated by source | XC10AXU011E002010102957 | NHSA |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20244779 | See source | Not stated by source | XC10AXU011E002010104021 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20265256 | See source | Not stated by source | XC10AXU011E002010104152 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20265690 | See source | Not stated by source | XC10AXU011E002010105765 | NHSA |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20244572 | See source | Not stated by source | XC10AXU011E002010109981 | NHSA |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H20223269 | See source | Not stated by source | XC10AXU011E002010180435 | NHSA |
| ABBOTT LABORATORIES LIMITED | 国药准字HJ20220042 | See source | Not stated by source | XC10AXU011E002010180487 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20213547 | See source | Not stated by source | XC10AXU011E002010180937 | NHSA |
| Beijing SL Pharmaceutical Co., Ltd. | 国药准字H20264179 | See source | Not stated by source | XC10AXU011E002010200148 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20244905 | See source | Not stated by source | XC10AXU011E002010201503 | NHSA |
| Yangtze River Pharmaceutical Group Co., Ltd | 国药准字H20249504 | See source | Not stated by source | XC10AXU011E002010201749 | NHSA |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20244779 | See source | Not stated by source | XC10AXU011E002010204021 | NHSA |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20244572 | See source | Not stated by source | XC10AXU011E002010209981 | NHSA |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H20223269 | See source | Not stated by source | XC10AXU011E002010280435 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20213547 | See source | Not stated by source | XC10AXU011E002010280937 | NHSA |
| Beijing SL Pharmaceutical Co., Ltd. | 国药准字H20264179 | See source | Not stated by source | XC10AXU011E002010300148 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20244905 | See source | Not stated by source | XC10AXU011E002010301503 | NHSA |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20244572 | See source | Not stated by source | XC10AXU011E002010309981 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20213547 | See source | Not stated by source | XC10AXU011E002010380937 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20244905 | See source | Not stated by source | XC10AXU011E002010401503 | NHSA |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20244572 | See source | Not stated by source | XC10AXU011E002010409981 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20213547 | See source | Not stated by source | XC10AXU011E002010480937 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20244905 | See source | Not stated by source | XC10AXU011E002010501503 | NHSA |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20244572 | See source | Not stated by source | XC10AXU011E002010509981 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20244905 | See source | Not stated by source | XC10AXU011E002010601503 | NHSA |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20244572 | See source | Not stated by source | XC10AXU011E002010609981 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20244905 | See source | Not stated by source | XC10AXU011E002010701503 | NHSA |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20244572 | See source | Not stated by source | XC10AXU011E002010709981 | NHSA |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20244572 | See source | Not stated by source | XC10AXU011E002010809981 | NHSA |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20244572 | See source | Not stated by source | XC10AXU011E002010909981 | NHSA |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20244572 | See source | Not stated by source | XC10AXU011E002011009981 | NHSA |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20244572 | See source | Not stated by source | XC10AXU011E002011109981 | NHSA |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20244572 | See source | Not stated by source | XC10AXU011E002011209981 | NHSA |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20244572 | See source | 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 |
|---|---|---|---|---|---|
| Shandong He Qi Pharmaceutical Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | 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 |
| Hainan Wan Wei Pharmaceutical Co., Ltd. romanized | CYHS2602150 | Generic | 2026/08/28 | Not stated by source | CDE |
| Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Da Lian Mei Chuang Pharma Co., Ltd. romanized | CYHS2601216 | Generic | 2026/06/01 | Not stated by source | CDE |
| Zhejiang Ya Feng Pharmaceutical Factory Co., Ltd. romanized | CYHS2601113 | Generic | 2026/05/13 | Not stated by source | CDE |
| Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized; Da Lian Mei Chuang Pharma Co., Ltd. romanized | CYHS2503246 | Generic | 2025/09/03 | Not stated by source | CDE |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | CYHS2502765 | Generic | 2025/08/01 | Not stated by source | CDE |
| Qingdao Shuang Jing Pharma Co., Ltd. romanized | CYHS2502736 | Generic | 2025/07/30 | Not stated by source | CDE |
| Li Zhu Group Li Zhu Pharmaceutical Factory romanized | 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 |
| Wen Zhou Hai He Pharma Co., Ltd. romanized | 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 |
|---|---|---|---|---|---|
| Shandong He Qi Pharmaceutical Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHS2600961 | Generic | 2026/04/25 | Not stated by source | CDE |
| Hainan Wan Wei Pharmaceutical Co., Ltd. romanized | CYHS2602150 | Generic | 2026/08/28 | Not stated by source | CDE |
| Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Da Lian Mei Chuang Pharma Co., Ltd. romanized | CYHS2601216 | Generic | 2026/06/01 | Not stated by source | CDE |
| Zhejiang Ya Feng Pharmaceutical Factory Co., Ltd. romanized | CYHS2601113 | Generic | 2026/05/13 | Not stated by source | CDE |
| Wen Zhou Hai He Pharma Co., Ltd. romanized | 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 · No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20250001501 | I | Exact ingredient | 2026/02/26 | CDE |
| ω-3脂肪酸乙酯90 · No verified English name | Hubei Ge Dian Ren Fu Yao Yong Fu Liao Co., Ltd. romanized | Y20250001264 | I | Exact ingredient | 2025/12/25 | CDE |
| ω-3脂肪酸乙酯90 · No verified English name | Sichuan Xin Mei Jia Biopharmaceuticals Co., Ltd. romanized | Y20240001165 | I | Exact ingredient | 2024/12/13 | CDE |
| ω-3脂肪酸乙酯90 · No verified English name | Sichuan Gowell Pharmaceutical Co., Ltd. | Y20190001013 | A | Exact ingredient | 2026/01/09 | CDE |
| ω-3脂肪酸乙酯90 · No verified English name | BASF AS | Y20180001358 | A | Exact ingredient | 2024/09/14 | CDE |
| ω-3脂肪酸乙酯90 · No verified English name | De Yang Ou Bo Bio Technology Co., Ltd. romanized | Y20190000382 | A | Exact ingredient | 2025/05/17 | CDE |
| ω-3脂肪酸乙酯90 · No verified English name | 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: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.
-
2026/10/30Accepted
Wen Zhou Hai He Pharma Co., Ltd. romanized
CYHS2602659
Fact date: 2026/10/30 · Site observation date: 2026/10/31
View source ↗ -
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
Hainan Wan Wei Pharmaceutical Co., Ltd. romanized
CYHS2602150
Fact date: 2026/08/28 · Site observation date: 2026/10/22
View source ↗
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/13 06:42
- Chemical-drug catalogue
- Last successful update: 2026/11/13 06:39
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: 2026/11/13 06:41
- 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: 2026/11/12 18:32 · Current coverage may be incomplete
First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/13 08:09 · 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: 7/30; discovered pending details: 13. 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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