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As of 13 November 2026, for Ethyl Iosapentate Capsules, 27 applications are listed as under review at China's CDE; 9 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 16 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 4 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.
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 holders16View records ↓
Under-review filings27View records ↓
This year’s generic filers9View 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 |
|---|---|---|---|---|---|---|
| Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized | Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20265933 | 2026/09/15 | 1.0g | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Innovation Bio Co., Ltd. romanized | Zhejiang Innovation Bio Co., Ltd. romanized | 国药准字H20265600 | 2026/08/04 | 1.0g | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized | Da Lian Mei Chuang Pharma Co., Ltd. romanized | 国药准字H20264795 | 2026/06/17 | 1.0g | Generic approved under the new chemical-drug registration classification | CDE |
| Gui Lin Nan Yao Co., Ltd. romanized | Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H20264546 | 2026/05/27 | 1.0g | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263744 | 2026/03/31 | 1.0g | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Ai Sheng Pharma Co., Ltd. romanized | Zhejiang Ai Sheng Pharma Co., Ltd. romanized | 国药准字H20263651 | 2026/03/17 | 1.0g | Generic approved under the new chemical-drug registration classification | CDE |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H20256145 | 2025/12/03 | 1.0g | Not stated by source | CDE |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H20256155 | 2025/12/03 | 0.5g | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H20255271 | 2025/09/02 | 1.0g | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H20255270 | 2025/09/02 | 0.5g | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Cheng Yi Pharma Co., Ltd. romanized | Zhejiang Cheng Yi Pharma Co., Ltd. romanized | 国药准字H20255236 | 2025/08/26 | 0.5g | 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H20255248 | 2025/08/26 | 1.0g | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Cheng Yi Pharma Co., Ltd. romanized | Zhejiang Cheng Yi Pharma Co., Ltd. romanized | 国药准字H20255237 | 2025/08/26 | 1.0g | 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H20255247 | 2025/08/26 | 0.5g | Generic approved under the new chemical-drug registration classification | CDE |
| Yangtze River Pharmaceutical Group Co., Ltd | Yangtze River Pharmaceutical Group Co., Ltd | 国药准字H20254982 | 2025/07/29 | 1.0g | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Kelun Pharmaceutical Co., Ltd. | Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20254869 | 2025/07/15 | 1.0g | Generic approved under the new chemical-drug registration classification | CDE |
| Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. | 国药准字H20254765 | 2025/06/30 | 1.0g | Generic approved under the new chemical-drug registration classification | CDE |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20254286 | 2025/05/27 | 1.0g | Generic approved under the new chemical-drug registration classification | CDE |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20254287 | 2025/05/27 | 0.5g | Generic approved under the new chemical-drug registration classification | CDE |
| Amarin Pharmaceuticals Ireland Ltd. | Patheon Softgels B.V. | 国药准字HJ20230058 | 2023/05/29 | 1.0g | Imported originator drug | CDE |
| Sichuan Gowell Pharmaceutical Co., Ltd. | Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20233110 | 2023/01/31 | 1.0g | 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: 16 distinct approval numbers and 13 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263744 | 1.0g | Not stated by source | XC10AXE095E002010101503 | NHSA |
| Yangtze River Pharmaceutical Group Co., Ltd | 国药准字H20254982 | 1.0g | Not stated by source | XC10AXE095E002010101749 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20254869 | 1.0g | Not stated by source | XC10AXE095E002010102180 | NHSA |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20254765 | 1.0g | Not stated by source | XC10AXE095E002010104021 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20254286 | 1.0g | Not stated by source | XC10AXE095E002010104187 | NHSA |
| Zhejiang Ai Sheng Pharma Co., Ltd. romanized | 国药准字H20263651 | 1.0g | Not stated by source | XC10AXE095E002010104604 | NHSA |
| Zhejiang Cheng Yi Pharma Co., Ltd. romanized | 国药准字H20255236 | 0.5g | Not stated by source | XC10AXE095E002010104615 | NHSA |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H20264546 | 1.0g | Not stated by source | XC10AXE095E002010105206 | NHSA |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20255247 | 0.5g | Not stated by source | XC10AXE095E002010109981 | NHSA |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H20255270 | 0.5g | Not stated by source | XC10AXE095E002010180435 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20233110 | 1.0g | Not stated by source | XC10AXE095E002010180937 | NHSA |
| Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized | 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 |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263744 | 1.0g | Not stated by source | XC10AXE095E002010201503 | NHSA |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20254765 | 1.0g | Not stated by source | XC10AXE095E002010204021 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20254286 | 1.0g | Not stated by source | XC10AXE095E002010204187 | NHSA |
| Zhejiang Ai Sheng Pharma Co., Ltd. romanized | 国药准字H20263651 | 1.0g | Not stated by source | XC10AXE095E002010204604 | NHSA |
| Zhejiang Cheng Yi Pharma Co., Ltd. romanized | 国药准字H20255236 | 0.5g | Not stated by source | XC10AXE095E002010204615 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20233110 | 1.0g | Not stated by source | XC10AXE095E002010280937 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263744 | 1.0g | Not stated by source | XC10AXE095E002010301503 | NHSA |
| Zhejiang Ai Sheng Pharma Co., Ltd. romanized | 国药准字H20263651 | 1.0g | Not stated by source | XC10AXE095E002010304604 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20233110 | 1.0g | Not stated by source | XC10AXE095E002010380937 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263744 | 1.0g | Not stated by source | XC10AXE095E002010401503 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20263744 | 1.0g | Not stated by source | XC10AXE095E002010501503 | NHSA |
| Zhejiang Cheng Yi Pharma Co., Ltd. romanized | 国药准字H20255237 | 1.0g | Not stated by source | XC10AXE095E002020104615 | NHSA |
| Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized | 国药准字H20255248 | 1.0g | Not stated by source | XC10AXE095E002020109981 | NHSA |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H20255271 | 1.0g | Not stated by source | XC10AXE095E002020180435 | NHSA |
| Zhejiang Cheng Yi Pharma Co., Ltd. romanized | 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: 27 filings and 22 distinct first applicants.
Generic 26 · Supplement 1
New generic filings in 2026
Loaded records: 12 filings and 9 distinct first applicants.
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 · No verified English name | Nissui Corporation | Y20250001446 | I | Exact ingredient | 2026/06/22 | CDE |
| 二十碳五烯酸乙酯 · No verified English name | Sichuan Gowell Pharmaceutical Co., Ltd. | Y20250000130 | A | Exact ingredient | 2026/06/24 | CDE |
| 二十碳五烯酸乙酯 · No verified English name | Name not romanized | Y20240000341 | I | Exact ingredient | 2024/07/11 | CDE |
| 二十碳五烯酸乙酯 · No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20230000457 | A | Exact ingredient | 2025/05/15 | CDE |
| 二十碳五烯酸乙酯 · No verified English name | BASF AS | Y20210001175 | A | Exact ingredient | 2026/02/04 | CDE |
| 二十碳五烯酸乙酯 · No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20210001073 | I | Exact ingredient | 2022/08/03 | CDE |
| 二十碳五烯酸乙酯 · No verified English name | Sichuan Gowell Pharmaceutical Co., Ltd. | Y20210000213 | A | Exact ingredient | 2023/02/07 | CDE |
| 二十碳五烯酸乙酯 · No verified English name | NISSHIN PHARMA INC. | Y20200001451 | A | Exact ingredient | 2025/09/13 | CDE |
| 二十碳五烯酸乙酯 · No verified English name | 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: 2026/11/13 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.
-
2026/11/11Accepted
NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized
CYHS2602770
Fact date: 2026/11/11 · Site observation date: 2026/11/12
View source ↗ -
2026/11/11Accepted
NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized
CYHS2602769
Fact date: 2026/11/11 · Site observation date: 2026/11/12
View source ↗ -
2026/11/03Marketing application approved
Gan Zheng (Hainan) Bio Pharma Co., Ltd. romanized
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
Beijing Kang Li Sheng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Anhui Yue Bo Biopharmaceutical Co., Ltd. romanized
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
Hunan Run Xing Pharma Co., Ltd. romanized; Hunan Xian Shi Pharmaceutical Co., Ltd. romanized
CYHS2602361
Fact date: 2026/09/21 · Site observation date: 2026/10/22
View source ↗ -
2026/09/10Accepted
Changzhou Si Yao Pharmaceutical Co., Ltd. romanized; Nan Tong Hua Shan Pharma Co., Ltd. romanized
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: 2026/11/13 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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