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As of 13 November 2026, for Ilaprazole Enteric-coated Tablets, 26 applications are listed as under review at China's CDE; 11 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 4 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 2 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 holders4View records ↓
Under-review filings26View records ↓
This year’s generic filers11View records ↓
NHSA approval numbers3View records ↓
API companies with A status14View records ↓
Chemical-drug catalogue
Loaded records: 4 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 3 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 |
|---|---|---|---|---|---|---|
| Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanized | Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263993 | 2026/04/14 | 5mg | Generic approved under the new chemical-drug registration classification | CDE |
| CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. | 国药准字H20253336 | 2025/02/08 | 5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Li Zhu Group Li Zhu Pharmaceutical Factory romanized | Li Zhu Group Li Zhu Pharmaceutical Factory romanized | 国药准字H20070256 | 2007/12/11 | 5mg | Innovative drug | CDE |
| Yun Peng Pharmaceuticals Group Co., Ltd. romanized | Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized | 国药准字H20266240 | 2026/10/13 | 5mg | 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: 3 distinct approval numbers and 3 companies.
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: 26 filings and 26 distinct first applicants.
Generic 25 · Supplement 1
New generic filings in 2026
Loaded records: 13 filings and 11 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Jilin Si Huan Pharmaceutical Co., Ltd. romanized | CYHS2602077 | Generic | 2026/08/20 | Not stated by source | CDE |
| Jiangsu He Chen Pharma Co., Ltd. romanized | CYHS2602103 | Generic | 2026/08/24 | Not stated by source | CDE |
| Jiangsu He Chen Pharma Co., Ltd. romanized | CYHS2601265 | Generic | 2026/06/04 | Not stated by source | CDE |
| Jiangsu Yong An Pharmaceutical Co., Ltd. romanized | CYHS2601826 | Generic | 2026/07/29 | Not stated by source | CDE |
| Guangdong An Nuo Pharma Co., Ltd. romanized | CYHS2601958 | Generic | 2026/08/10 | Not stated by source | CDE |
| Beijing Foyou Pharma CO.,LTD | CYHS2601671 | Generic | 2026/07/14 | Not stated by source | CDE |
| Guangdong An Nuo Pharma Co., Ltd. romanized | CYHS2601261 | Generic | 2026/06/04 | Not stated by source | CDE |
| Hebei Long Hai Pharma Co., Ltd. romanized | CYHS2601289 | Generic | 2026/06/03 | Not stated by source | CDE |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | CYHS2601203 | Generic | 2026/05/27 | Not stated by source | CDE |
| Shandong Yao Shi Pharma Co., Ltd. romanized | CYHS2601030 | Generic | 2026/05/07 | Not stated by source | CDE |
| Hunan Ou La Pharmaceuticals Technology Co., Ltd. romanized; Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | CYHS2600641 | Generic | 2026/03/11 | Not stated by source | CDE |
| HUNAN WARRANT PHARMACEUTICAL CO.,LTD | CYHS2600187 | Generic | 2026/01/16 | Not stated by source | CDE |
| Zhejiang Yi Han Pharmaceutical Co., Ltd. romanized | CYHS2600125 | Generic | 2026/01/10 | Not stated by source | CDE |
API registrations
Non-component matches: 14 companies with A status and 18 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 |
|---|---|---|---|---|---|---|
| 艾普拉唑钠 · No verified English name | Lian Yun Gang Gui Ke Pharma Co., Ltd. romanized | Y20260000381 | I | Salt-normalized ingredient | 2026/06/03 | CDE |
| 艾普拉唑 · No verified English name | Beijing Foyou Pharma CO.,LTD | Y20260000360 | I | Exact ingredient | 2026/04/30 | CDE |
| 艾普拉唑钠 · No verified English name | Shandong Chen Long Pharma Co., Ltd. romanized | Y20260000104 | I | Salt-normalized ingredient | 2026/02/09 | CDE |
| 艾普拉唑 · No verified English name | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | Y20250001430 | I | Exact ingredient | 2026/01/05 | CDE |
| 艾普拉唑 · No verified English name | Jiao Zuo Li Zhu He Cheng Pharmaceutical Co., Ltd. romanized | Y20250001162 | I | Exact ingredient | 2025/11/11 | CDE |
| 艾普拉唑 · No verified English name | Fujian Nan Fang Pharmaceutical Co., Ltd. romanized | Y20250001063 | I | Exact ingredient | 2025/10/15 | CDE |
| 艾普拉唑 · No verified English name | Sichuan Kelun Pharmaceutical Co., Ltd. | Y20250000807 | I | Exact ingredient | 2025/09/29 | CDE |
| 艾普拉唑 · No verified English name | Xin Tian Di Pharma Co., Ltd. romanized | Y20250001026 | I | Exact ingredient | 2025/09/28 | CDE |
| 艾普拉唑 · No verified English name | Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized | Y20250000996 | I | Exact ingredient | 2025/09/19 | CDE |
| 艾普拉唑 · No verified English name | Hunan Hua Na Da Pharmaceutical Factory Shou Xing Drug Co., Ltd. romanized | Y20250000860 | I | Exact ingredient | 2025/09/03 | CDE |
| 艾普拉唑 · No verified English name | Suzhou Sheng Da Pharma Co., Ltd. romanized | Y20250000771 | I | Exact ingredient | 2025/08/12 | CDE |
| 艾普拉唑 · No verified English name | Hubei Sai Ao Biopharmaceutical Co., Ltd. romanized | Y20250000710 | I | Exact ingredient | 2025/07/18 | CDE |
| 艾普拉唑 · No verified English name | Chongqing Lai Mei Long Yu Pharma Co., Ltd. romanized | Y20250000565 | I | Exact ingredient | 2025/07/14 | CDE |
| 艾普拉唑 · No verified English name | Suzhou Sheng Da Pharma Co., Ltd. romanized | Y20250000404 | I | Exact ingredient | 2025/06/10 | CDE |
| 艾普拉唑 · No verified English name | Zhejiang Mei Nuo Hua Drug Chemical Co., Ltd. romanized | Y20240000994 | I | Exact ingredient | 2025/06/04 | CDE |
| 艾普拉唑 · No verified English name | Zhuhai Hai Rui De Pharmaceutical Co., Ltd. romanized | Y20250000381 | A | Exact ingredient | 2026/09/22 | CDE |
| 艾普拉唑 · No verified English name | Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | Y20250000339 | I | Exact ingredient | 2025/04/27 | CDE |
| 艾普拉唑 · No verified English name | Shandong Chen Long Pharma Co., Ltd. romanized | Y20250000029 | A | Exact ingredient | 2026/08/31 | CDE |
| 艾普拉唑 · No verified English name | Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | Y20240001539 | A | Exact ingredient | 2026/07/13 | CDE |
| 艾普拉唑钠 · No verified English name | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | Y20240001344 | I | Salt-normalized ingredient | 2024/12/30 | CDE |
| 艾普拉唑 · No verified English name | Gansu Hao Tian Pharmaceuticals Technology Co., Ltd. romanized | Y20240001388 | A | Exact ingredient | 2026/07/20 | CDE |
| 艾普拉唑 · No verified English name | Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | Y20240001317 | A | Exact ingredient | 2026/04/21 | CDE |
| 艾普拉唑 · No verified English name | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | Y20240001265 | A | Exact ingredient | 2026/09/21 | CDE |
| 艾普拉唑 · No verified English name | Lian Yun Gang Gui Ke Pharma Co., Ltd. romanized | Y20240001155 | A | Exact ingredient | 2026/05/20 | CDE |
| 艾普拉唑 · No verified English name | Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | Y20240000870 | A | Exact ingredient | 2026/01/05 | CDE |
| 艾普拉唑 · No verified English name | Sichuan Qing Mu Pharmaceutical Co., Ltd. romanized | Y20240000867 | A | Exact ingredient | 2026/01/16 | CDE |
| 艾普拉唑 · No verified English name | Hebei An Jian Cheng Yi Pharmaceuticals Technology Co., Ltd. romanized | Y20240000861 | A | Exact ingredient | 2025/12/29 | CDE |
| 艾普拉唑 · No verified English name | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Y20240000700 | I | Exact ingredient | 2024/08/05 | CDE |
| 艾普拉唑 · No verified English name | Chengdu Tong De Pharma Co., Ltd. romanized | Y20240000521 | A | Exact ingredient | 2025/12/29 | CDE |
| 艾普拉唑钠 · No verified English name | Zhejiang Heng Kang Pharma Co., Ltd. romanized | Y20230001212 | A | Salt-normalized ingredient | 2026/01/21 | CDE |
| 艾普拉唑 · No verified English name | Zhejiang Heng Kang Pharma Co., Ltd. romanized | Y20230001213 | A | Exact ingredient | 2025/08/06 | CDE |
| 艾普拉唑 · No verified English name | CSPC OUYI PHARMACEUTICAL CO., LTD. | Y20230000888 | A | Exact ingredient | 2025/02/15 | CDE |
| 艾普拉唑 · No verified English name | Zhuhai Bao Shui Qu Li Zhu He Cheng Pharmaceutical Co., Ltd. romanized | Y20190009784 | A | Exact ingredient | 2026/01/13 | CDE |
| 艾普拉唑钠 · No verified English name | Zhuhai Bao Shui Qu Li Zhu He Cheng Pharmaceutical Co., Ltd. romanized | Y20170001429 | A | Salt-normalized ingredient | 2023/03/24 | 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.
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.
-
2026/11/03Marketing application approved
CISEN PHARMACEUTICAL CO., LTD.
CYHS2502594 · 国药准字H20266477
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 98 ↗ -
2026/08/24Accepted
Jiangsu He Chen Pharma Co., Ltd. romanized
CYHS2602103
Fact date: 2026/08/24 · Site observation date: 2026/10/21
View source ↗ -
2026/08/20Accepted
Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Jilin Si Huan Pharmaceutical Co., Ltd. romanized
CYHS2602077
Fact date: 2026/08/20 · 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.
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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