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Sign in to subscribeEzetimibe and Atorvastatin Calcium Tablets(II)
As of 13 November 2026, for Ezetimibe and Atorvastatin Calcium Tablets(II), 12 applications are listed as under review at China's CDE; 3 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 8 holders.
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.
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 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 |
|---|---|---|---|---|---|---|
| Hua Run Sai Ke Pharma Co., Ltd. romanized | Hua Run Sai Ke Pharma Co., Ltd. romanized | 国药准字H20265907 | 2026/09/08 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hubei Min Kang Pharma Group Co., Ltd. romanized | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H20265482 | 2026/08/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20264559 | 2026/05/27 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Le Pu Pharmaceutical Technology Co., Ltd. romanized | Le Pu Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20256420 | 2025/12/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20255179 | 2025/08/19 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Foyou Pharma CO.,LTD | Beijing Foyou Pharma CO.,LTD | 国药准字H20253380 | 2025/02/11 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized | Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H20253267 | 2025/01/24 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Hua Yuan Pharma Co., Ltd. romanized | Zhejiang Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20266075 | 2026/09/22 | 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: 8 distinct approval numbers and 8 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20255179 | See source | Category B | XC10BAY348A001010102013 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20264559 | See source | Category B | XC10BAY348A001010109568 | NHSA |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20255179 | See source | Category B | XC10BAY348A001010202013 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20264559 | See source | Category B | XC10BAY348A001010209568 | NHSA |
| Hua Run Sai Ke Pharma Co., Ltd. romanized | 国药准字H20265907 | See source | Category B | XC10BAY348A001010100111 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253380 | See source | Category B | XC10BAY348A001010100177 | NHSA |
| N.V. Organon | 国药准字HJ20230110 | See source | Category B | XC10BAY348A001010179034 | NHSA |
| Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized | 国药准字H20253267 | See source | Category B | XC10BAY348A001010180539 | NHSA |
| Le Pu Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20256420 | See source | Category B | XC10BAY348A001010182919 | NHSA |
| Hubei Min Kang Pharma Group Co., Ltd. romanized | 国药准字H20265482 | See source | Category B | XC10BAY348A001010184564 | NHSA |
| Hua Run Sai Ke Pharma Co., Ltd. romanized | 国药准字H20265907 | See source | Category B | XC10BAY348A001010200111 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253380 | See source | Category B | XC10BAY348A001010200177 | NHSA |
| N.V. Organon | 国药准字HJ20230110 | See source | Category B | XC10BAY348A001010279034 | NHSA |
| Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized | 国药准字H20253267 | See source | Category B | XC10BAY348A001010280539 | NHSA |
| Le Pu Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20256420 | See source | Category B | XC10BAY348A001010282919 | NHSA |
| Hubei Min Kang Pharma Group Co., Ltd. romanized | 国药准字H20265482 | See source | Category B | XC10BAY348A001010284564 | NHSA |
| Hua Run Sai Ke Pharma Co., Ltd. romanized | 国药准字H20265907 | See source | Category B | XC10BAY348A001010300111 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253380 | See source | Category B | XC10BAY348A001010300177 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253380 | See source | Category B | XC10BAY348A001010400177 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253380 | See source | Category B | XC10BAY348A001010500177 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253380 | See source | Category B | XC10BAY348A001010600177 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253380 | See source | Category B | XC10BAY348A001010700177 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253380 | See source | Category B | 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 |
|---|---|---|---|---|---|
| Hubei Wu Shi Pharma Co., Ltd. romanized | CYHS2500653 | Generic | 2025/02/09 | Not stated by source | CDE |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | CYHS2600574 | Generic | 2026/02/28 | Not stated by source | CDE |
| Zhejiang Jiang Bei Pharma Co., Ltd. romanized | CYHS2503643 | Generic | 2025/10/14 | Not stated by source | CDE |
| Jiangsu Kang Yuan Pharma Co., Ltd. romanized | CYHS2503814 | Generic | 2025/10/28 | Not stated by source | CDE |
| N.V. Organon; Name not romanized; Name not romanized | JYHB2600493 | Supplement | 2026/08/27 | Not stated by source | CDE |
| Zhejiang Kang De Pharma Group Co., Ltd. romanized | CYHS2600866 | Generic | 2026/04/15 | Not stated by source | CDE |
| Kunming Ji Da Pharmaceutical Co., Ltd. romanized | CYHS2600201 | Generic | 2026/01/16 | Not stated by source | CDE |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | CYHS2504495 | Generic | 2025/12/31 | Not stated by source | CDE |
| Chengdu Kang Tai Yuan Pharmaceuticals Technology Co., Ltd. romanized; Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized | CYHS2504382 | Generic | 2025/12/25 | Not stated by source | CDE |
| Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | CYHS2503531 | Generic | 2025/09/28 | Not stated by source | CDE |
| Chengdu Di Ao Jiu Hong Pharmaceutical Factory romanized; Di Ao Group Chengdu Pharma Co., Ltd. romanized | CYHS2503527 | Generic | 2025/09/28 | Not stated by source | CDE |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 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 |
|---|---|---|---|---|---|
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | CYHS2600574 | Generic | 2026/02/28 | Not stated by source | CDE |
| Zhejiang Kang De Pharma Group Co., Ltd. romanized | CYHS2600866 | Generic | 2026/04/15 | Not stated by source | CDE |
| Kunming Ji Da Pharmaceutical Co., Ltd. romanized | 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: 2026/11/13 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.
-
2026/10/31No longer listed under review
N.V. Organon; Name not romanized; Name not romanized
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
Ou Jia Long (Shanghai) Pharmaceuticals Technology Co., Ltd., N. V. Organon romanized
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; Name not romanized; Name not romanized
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: 2026/11/13 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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