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As of 13 November 2026, for Brexpiprazole Orally Disintegrating Tablets, 10 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 6 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 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 holders6View records ↓
Under-review filings10View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers9View records ↓
API companies with A status30View records ↓
Chemical-drug catalogue
Loaded records: 6 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 6 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 Foyou Pharma CO.,LTD | Beijing Foyou Pharma CO.,LTD | 国药准字H20265551 | 2026/08/04 | 1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Foyou Pharma CO.,LTD | Beijing Foyou Pharma CO.,LTD | 国药准字H20265550 | 2026/08/04 | 2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hua Yi Tai Kang Pharma Co., Ltd. romanized | Hua Yi Tai Kang Pharma Co., Ltd. romanized | 国药准字H20264768 | 2026/06/10 | 2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hua Yi Tai Kang Pharma Co., Ltd. romanized | Hua Yi Tai Kang Pharma Co., Ltd. romanized | 国药准字H20264767 | 2026/06/10 | 1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20264111 | 2026/04/21 | 2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20264082 | 2026/04/21 | 1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20264083 | 2026/04/21 | 0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20263548 | 2026/03/10 | 1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. | 国药准字H20263260 | 2026/01/27 | 2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. | 国药准字H20263259 | 2026/01/27 | 1mg | Generic approved under the new chemical-drug registration classification | CDE |
| Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. | 国药准字H20263258 | 2026/01/27 | 0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20263549 | 2026/03/10 | 2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H20266440 | 2026/11/03 | 0.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H20266438 | 2026/11/03 | 2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H20266439 | 2026/11/03 | 1mg | 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: 9 distinct approval numbers and 4 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Beijing Foyou Pharma CO.,LTD | 国药准字H20265551 | 1mg | Not stated by source | XN05AXB266A022010100177 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20264083 | 0.5mg | Not stated by source | XN05AXB266A022010104188 | NHSA |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20263548 | 1mg | Not stated by source | XN05AXB266A022010104948 | NHSA |
| Hua Yi Tai Kang Pharma Co., Ltd. romanized | 国药准字H20264767 | 1mg | Not stated by source | XN05AXB266A022010105819 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20265551 | 1mg | Not stated by source | XN05AXB266A022010200177 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20264083 | 0.5mg | Not stated by source | XN05AXB266A022010204188 | NHSA |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20263548 | 1mg | Not stated by source | XN05AXB266A022010204948 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20265551 | 1mg | Not stated by source | XN05AXB266A022010300177 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20264083 | 0.5mg | Not stated by source | XN05AXB266A022010304188 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20265551 | 1mg | Not stated by source | XN05AXB266A022010400177 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20264083 | 0.5mg | Not stated by source | XN05AXB266A022010404188 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20264083 | 0.5mg | Not stated by source | XN05AXB266A022010504188 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20265550 | 2mg | Not stated by source | XN05AXB266A022020100177 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20264082 | 1mg | Not stated by source | XN05AXB266A022020104188 | NHSA |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20263549 | 2mg | Not stated by source | XN05AXB266A022020104948 | NHSA |
| Hua Yi Tai Kang Pharma Co., Ltd. romanized | 国药准字H20264768 | 2mg | Not stated by source | XN05AXB266A022020105819 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20265550 | 2mg | Not stated by source | XN05AXB266A022020200177 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20264082 | 1mg | Not stated by source | XN05AXB266A022020204188 | NHSA |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20263549 | 2mg | Not stated by source | XN05AXB266A022020204948 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20265550 | 2mg | Not stated by source | XN05AXB266A022020300177 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20264082 | 1mg | Not stated by source | XN05AXB266A022020304188 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20265550 | 2mg | Not stated by source | XN05AXB266A022020400177 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20264082 | 1mg | Not stated by source | XN05AXB266A022020404188 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20264082 | 1mg | Not stated by source | XN05AXB266A022020504188 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20264111 | 2mg | Not stated by source | XN05AXB266A022030104188 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20264111 | 2mg | Not stated by source | XN05AXB266A022030204188 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20264111 | 2mg | Not stated by source | XN05AXB266A022030304188 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20264111 | 2mg | Not stated by source | XN05AXB266A022030404188 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20264111 | 2mg | Not stated by source | XN05AXB266A022030504188 | 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: 10 filings and 4 distinct first applicants.
Generic 10
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | CYHS2601963 | Generic | 2026/08/11 | Not stated by source | CDE |
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | CYHS2601962 | Generic | 2026/08/11 | Not stated by source | CDE |
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | CYHS2601961 | Generic | 2026/08/11 | Not stated by source | CDE |
| Hebei Long Hai Pharma Co., Ltd. romanized | CYHS2600937 | Generic | 2026/04/23 | Not stated by source | CDE |
| Hebei Long Hai Pharma Co., Ltd. romanized | CYHS2600936 | Generic | 2026/04/23 | Not stated by source | CDE |
| Yan Tai Ju Xian Pharma Co., Ltd. romanized | CYHS2503451 | Generic | 2025/09/18 | Not stated by source | CDE |
| Yan Tai Ju Xian Pharma Co., Ltd. romanized | CYHS2503450 | Generic | 2025/09/18 | Not stated by source | CDE |
| Hangzhou He Kang Pharma Co., Ltd. romanized | CYHS2501864 | Generic | 2025/05/23 | Not stated by source | CDE |
| Hangzhou He Kang Pharma Co., Ltd. romanized | CYHS2501863 | Generic | 2025/05/23 | Not stated by source | CDE |
| Hangzhou He Kang Pharma Co., Ltd. romanized | CYHS2501862 | Generic | 2025/05/23 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 5 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | CYHS2601963 | Generic | 2026/08/11 | Not stated by source | CDE |
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | CYHS2601962 | Generic | 2026/08/11 | Not stated by source | CDE |
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | CYHS2601961 | Generic | 2026/08/11 | Not stated by source | CDE |
| Hebei Long Hai Pharma Co., Ltd. romanized | CYHS2600937 | Generic | 2026/04/23 | Not stated by source | CDE |
| Hebei Long Hai Pharma Co., Ltd. romanized | CYHS2600936 | Generic | 2026/04/23 | Not stated by source | CDE |
API registrations
Non-component matches: 30 companies with A status and 5 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 |
|---|---|---|---|---|---|---|
| 布瑞哌唑 · No verified English name | Hebei Guang Xiang Pharmaceutical Co., Ltd. romanized | Y20260000216 | I | Exact ingredient | 2026/04/07 | CDE |
| 布瑞哌唑 · No verified English name | Hunan Yi Ge Pharmaceutical Co., Ltd. romanized | Y20260000066 | I | Exact ingredient | 2026/02/14 | CDE |
| 布瑞哌唑 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20250001338 | I | Exact ingredient | 2025/12/23 | CDE |
| 布瑞哌唑 · No verified English name | Gansu Hai Pu Nuo Rui Chuang Pharmaceutical Co., Ltd. romanized | Y20250001255 | I | Exact ingredient | 2025/12/10 | CDE |
| 布瑞哌唑 · No verified English name | Ru Yuan Dong Yang Guang Pharma Co., Ltd. romanized | Y20250000540 | I | Exact ingredient | 2025/06/06 | CDE |
| 布瑞哌唑 · No verified English name | Yun Peng Pharmaceuticals Group Co., Ltd. romanized | Y20250000268 | A | Exact ingredient | 2026/08/13 | CDE |
| 布瑞哌唑 · No verified English name | Jiangsu En Hua Pharma Co., Ltd. romanized | Y20250000258 | A | Exact ingredient | 2026/08/06 | CDE |
| 布瑞哌唑 · No verified English name | Guangdong Xian Qiang Pharma Co., Ltd. romanized | Y20250000228 | A | Exact ingredient | 2026/07/28 | CDE |
| 布瑞哌唑 · No verified English name | Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized | Y20250000127 | A | Exact ingredient | 2026/09/21 | CDE |
| 布瑞哌唑 · No verified English name | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized | Y20250000085 | A | Exact ingredient | 2026/06/01 | CDE |
| 布瑞哌唑 · No verified English name | CSPC OUYI PHARMACEUTICAL CO., LTD. | Y20240001524 | A | Exact ingredient | 2026/07/04 | CDE |
| 布瑞哌唑 · No verified English name | Gansu Hao Tian Pharmaceuticals Technology Co., Ltd. romanized | Y20240001562 | A | Exact ingredient | 2026/08/13 | CDE |
| 布瑞哌唑 · No verified English name | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Y20240001555 | A | Exact ingredient | 2026/08/24 | CDE |
| 布瑞哌唑 · No verified English name | Shandong Lukang Pharmaceutical Co.,Ltd. | Y20240001517 | A | Exact ingredient | 2026/10/09 | CDE |
| 布瑞哌唑 · No verified English name | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20240001445 | A | Exact ingredient | 2026/07/21 | CDE |
| 布瑞哌唑 · No verified English name | Beijing Foyou Pharma CO.,LTD | Y20240001452 | A | Exact ingredient | 2026/04/22 | CDE |
| 布瑞哌唑 · No verified English name | Zhejiang Jing Sheng Pharma Co., Ltd. romanized | Y20240001143 | A | Exact ingredient | 2026/07/13 | CDE |
| 布瑞哌唑 · No verified English name | Tianjin Tai Pu Pharmaceutical Co., Ltd. romanized | Y20240000883 | A | Exact ingredient | 2025/12/29 | CDE |
| 布瑞哌唑 · No verified English name | Liaoning Bei Feng Pharma Co., Ltd. romanized | Y20240000819 | A | Exact ingredient | 2026/03/06 | CDE |
| 布瑞哌唑 · No verified English name | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | Y20240000877 | A | Exact ingredient | 2026/05/20 | CDE |
| 布瑞哌唑 · No verified English name | Zhejiang Guo Bang Pharma Co., Ltd. romanized | Y20240000722 | A | Exact ingredient | 2026/09/13 | CDE |
| 布瑞哌唑 · No verified English name | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20240000766 | A | Exact ingredient | 2026/03/19 | CDE |
| 布瑞哌唑 · No verified English name | Sichuan Hong Yuan Pharma Co., Ltd. romanized | Y20240000696 | A | Exact ingredient | 2026/08/11 | CDE |
| 布瑞哌唑 · No verified English name | Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20240000533 | A | Exact ingredient | 2025/11/28 | CDE |
| 布瑞哌唑 · No verified English name | Shandong Chen Long Pharma Co., Ltd. romanized | Y20240000693 | A | Exact ingredient | 2025/11/14 | CDE |
| 布瑞哌唑 · No verified English name | Shandong An Hong Pharmaceutical Co., Ltd. romanized | Y20240000591 | A | Exact ingredient | 2025/12/14 | CDE |
| 布瑞哌唑 · No verified English name | Sichuan Qing Mu Pharmaceutical Co., Ltd. romanized | Y20240000436 | A | Exact ingredient | 2025/08/22 | CDE |
| 布瑞哌唑 · No verified English name | Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | Y20230001153 | A | Exact ingredient | 2026/03/06 | CDE |
| 布瑞哌唑 · No verified English name | Heilongjiang Zhen Bao Dao Pharma Co., Ltd. Ji Xi Branch romanized | Y20230000743 | A | Exact ingredient | 2026/03/09 | CDE |
| 布瑞哌唑 · No verified English name | Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | Y20230000669 | A | Exact ingredient | 2026/02/10 | CDE |
| 布瑞哌唑 · No verified English name | Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd. | Y20230000283 | A | Exact ingredient | 2026/06/16 | CDE |
| 布瑞哌唑 · No verified English name | Sichuan Kelun Pharmaceutical Co., Ltd. | Y20220000975 | A | Exact ingredient | 2026/08/27 | CDE |
| 布瑞哌唑 · No verified English name | Honour Lab Limited, Unit - III romanized | Y20210000838 | A | Exact ingredient | 2026/07/04 | CDE |
| 布瑞哌唑 · No verified English name | Shandong Te Fa Man Pharma Co., Ltd. romanized | Y20210000803 | A | Exact ingredient | 2026/06/18 | CDE |
| 布瑞哌唑 · No verified English name | Hunan Dong Ting Pharma Co., Ltd. romanized | Y20200001055 | A | Exact ingredient | 2026/05/18 | 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.
-
2026/11/03Marketing application approved
Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
CYHS2500513 · 国药准字H20266440
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 26 ↗ -
2026/11/03Marketing application approved
Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
CYHS2500512 · 国药准字H20266439
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 25 ↗ -
2026/11/03Marketing application approved
Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
CYHS2500511 · 国药准字H20266438
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 24 ↗
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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