Monthly
US$200
Billed every month
Brivaracetam Tablets(布立西坦片)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 8 applicationsNo longer listed under review: 1 applicationNotification delivery: 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.
Company names, approval identifiers and strengths are retained as recorded in the Chinese sources. Category labels include the original wording for verification.
Catalogue holders1View records ↓
Under-review filings18View records ↓
This year’s generic filers7View records ↓
NHSA approval numbers2View records ↓
API companies with A status7View records ↓
Chemical-drug catalogue
Loaded records: 1 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 1 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 |
|---|---|---|---|---|---|---|
| 江西青峰药业有限公司 | 江西青峰药业有限公司 | 国药准字H20244272 | 2024/06/28 | 50mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 江西青峰药业有限公司 | 江西青峰药业有限公司 | 国药准字H20244271 | 2024/06/28 | 25mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | 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: 2 distinct approval numbers and 1 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 江西科睿药业有限公司 | 国药准字H20244272 | 50mg | Category B (乙) | XN03AXB264A001010105337 | NHSA |
| 江西科睿药业有限公司 | 国药准字H20244271 | 25mg | Category B (乙) | XN03AXB264A001020105337 | 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: 18 filings and 8 distinct first applicants.
Generic 16 · Supplement 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 浙江诺得药业有限公司 | CYHS2602090 | Generic | 2026/08/21 | Not stated by source | CDE |
| 浙江诺得药业有限公司 | CYHS2602089 | Generic | 2026/08/21 | Not stated by source | CDE |
| 浙江诺得药业有限公司 | CYHS2602088 | Generic | 2026/08/21 | Not stated by source | CDE |
| 西南药业股份有限公司 | CYHS2602507 | Generic | 2026/10/13 | Not stated by source | CDE |
| 山东朗诺制药有限公司 | CYHS2602456 | Generic | 2026/10/09 | Not stated by source | CDE |
| 山东朗诺制药有限公司 | CYHS2602455 | Generic | 2026/10/09 | Not stated by source | CDE |
| 江西科睿药业有限公司 | CYHB2601498 | Supplement | 2026/08/04 | Not stated by source | CDE |
| 江西科睿药业有限公司 | CYHB2601497 | Supplement | 2026/08/04 | Not stated by source | CDE |
| 浙江普洛康裕制药有限公司 | CYHS2601699 | Generic | 2026/07/16 | Not stated by source | CDE |
| 浙江普洛康裕制药有限公司 | CYHS2601698 | Generic | 2026/07/16 | Not stated by source | CDE |
| 浙江普洛康裕制药有限公司 | CYHS2601697 | Generic | 2026/07/16 | Not stated by source | CDE |
| 浙江华海药业股份有限公司 | CYHS2600068 | Generic | 2026/01/08 | Not stated by source | CDE |
| 浙江华海药业股份有限公司 | CYHS2600067 | Generic | 2026/01/08 | Not stated by source | CDE |
| 浙江华海药业股份有限公司 | CYHS2600065 | Generic | 2026/01/08 | Not stated by source | CDE |
| 浙江和泽医药科技股份有限公司;浙江京新药业股份有限公司 | CYHS2501808 | Generic | 2025/05/17 | Not stated by source | CDE |
| 浙江和泽医药科技股份有限公司;浙江京新药业股份有限公司 | CYHS2501807 | Generic | 2025/05/17 | Not stated by source | CDE |
| 宜昌人福药业有限责任公司 | CYHS2602745 | Generic | 2026/11/09 | Not stated by source | CDE |
| 宜昌人福药业有限责任公司 | CYHS2602744 | Generic | 2026/11/09 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 17 filings and 7 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 浙江诺得药业有限公司 | CYHS2602090 | Generic | 2026/08/21 | Not stated by source | CDE |
| 浙江诺得药业有限公司 | CYHS2602089 | Generic | 2026/08/21 | Not stated by source | CDE |
| 浙江诺得药业有限公司 | CYHS2602088 | Generic | 2026/08/21 | Not stated by source | CDE |
| 西南药业股份有限公司 | CYHS2602507 | Generic | 2026/10/13 | Not stated by source | CDE |
| 山东朗诺制药有限公司 | CYHS2602456 | Generic | 2026/10/09 | Not stated by source | CDE |
| 山东朗诺制药有限公司 | CYHS2602455 | Generic | 2026/10/09 | Not stated by source | CDE |
| 浙江普洛康裕制药有限公司 | CYHS2601699 | Generic | 2026/07/16 | Not stated by source | CDE |
| 浙江普洛康裕制药有限公司 | CYHS2601698 | Generic | 2026/07/16 | Not stated by source | CDE |
| 浙江普洛康裕制药有限公司 | CYHS2601697 | Generic | 2026/07/16 | Not stated by source | CDE |
| 成都奥邦药业有限公司 | CYHS2600146 | Generic | 2026/01/13 | Not stated by source | CDE |
| 成都奥邦药业有限公司 | CYHS2600145 | Generic | 2026/01/13 | Not stated by source | CDE |
| 浙江华海药业股份有限公司 | CYHS2600068 | Generic | 2026/01/08 | Not stated by source | CDE |
| 浙江华海药业股份有限公司 | CYHS2600067 | Generic | 2026/01/08 | Not stated by source | CDE |
| 浙江华海药业股份有限公司 | CYHS2600066 | Generic | 2026/01/08 | Not stated by source | CDE |
| 浙江华海药业股份有限公司 | CYHS2600065 | Generic | 2026/01/08 | Not stated by source | CDE |
| 宜昌人福药业有限责任公司 | CYHS2602745 | Generic | 2026/11/09 | Not stated by source | CDE |
| 宜昌人福药业有限责任公司 | CYHS2602744 | Generic | 2026/11/09 | Not stated by source | CDE |
API registrations
Non-component matches: 7 companies with A status and 24 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 |
|---|---|---|---|---|---|---|
| 布立西坦 | 宜昌天仁药业有限责任公司 | Y20260000858 | I | Exact ingredient | 2026/10/12 | CDE |
| 布立西坦 | 成都奥邦药业有限公司 | Y20260000747 | I | Exact ingredient | 2026/09/09 | CDE |
| 布立西坦 | 浙江普洛家园药业有限公司 | Y20250001382 | I | Exact ingredient | 2026/01/05 | CDE |
| 布立西坦 | 四川汇宇制药股份有限公司 | Y20250001175 | I | Exact ingredient | 2025/11/13 | CDE |
| 布立西坦 | 河北一品制药股份有限公司 | Y20250000528 | I | Exact ingredient | 2025/06/13 | CDE |
| 布立西坦 | 扬州奥锐特药业有限公司 | Y20250000343 | I | Exact ingredient | 2025/05/20 | CDE |
| 布立西坦 | 浙江东亚药业股份有限公司 | Y20250000038 | A | Exact ingredient | 2026/10/10 | CDE |
| 布立西坦 | 上海中西三维药业有限公司 | Y20240001549 | I | Exact ingredient | 2025/02/26 | CDE |
| 布立西坦 | 植恩生物技术股份有限公司 | Y20240001550 | I | Exact ingredient | 2025/01/13 | CDE |
| 布立西坦 | 浙江华海药业股份有限公司 | Y20240001376 | A | Exact ingredient | 2026/06/24 | CDE |
| 布立西坦 | 浙江美诺华药物化学有限公司 | Y20240000959 | A | Exact ingredient | 2026/06/04 | CDE |
| 布立西坦 | 浙江天宇药业股份有限公司 | Y20240000776 | A | Exact ingredient | 2026/06/01 | CDE |
| 布立西坦 | 四川科伦药业股份有限公司 | Y20240000811 | I | Exact ingredient | 2025/11/10 | CDE |
| 布立西坦 | 四川青木制药有限公司 | Y20240000752 | I | Exact ingredient | 2025/10/27 | CDE |
| 布立西坦 | 上海迪赛诺化学制药有限公司 | Y20240000746 | A | Exact ingredient | 2026/05/07 | CDE |
| 布立西坦 | 桂林南药股份有限公司 | Y20240000394 | I | Exact ingredient | 2025/10/27 | CDE |
| 布立西坦 | 湖北保乐生物医药科技有限公司 | Y20230000993 | I | Exact ingredient | 2023/11/24 | CDE |
| 布立西坦 | 亚宝药业集团股份有限公司 | Y20230000692 | I | Exact ingredient | 2023/08/22 | CDE |
| 布立西坦 | 山东辰龙药业有限公司 | Y20230000549 | A | Exact ingredient | 2025/12/29 | CDE |
| 布立西坦 | 成都百裕制药股份有限公司 | Y20210000848 | I | Exact ingredient | 2023/06/13 | CDE |
| 布立西坦 | 济川药业集团有限公司 | Y20230000249 | I | Exact ingredient | 2023/04/06 | CDE |
| 布立西坦 | 成都奥邦药业有限公司 | Y20230000092 | I | Exact ingredient | 2023/03/22 | CDE |
| 布立西坦 | 福建南方制药股份有限公司 | Y20220001065 | I | Exact ingredient | 2023/01/30 | CDE |
| 布立西坦 | 江西科睿药业有限公司 | Y20220001288 | A | Exact ingredient | 2024/12/27 | CDE |
| 布立西坦 | 浙江华海药业股份有限公司 | Y20220001275 | A | Exact ingredient | 2026/03/31 | CDE |
| 布立西坦 | 浙江乐普药业股份有限公司 | Y20220000078 | I | Exact ingredient | 2022/08/24 | CDE |
| 布立西坦 | 重庆博腾制药科技股份有限公司 | Y20220000198 | I | Exact ingredient | 2022/07/20 | CDE |
| 布立西坦 | 扬州奥锐特药业有限公司 | Y20220000479 | I | Exact ingredient | 2022/07/14 | CDE |
| 布立西坦 | 乳源东阳光药业有限公司 | Y20210000784 | I | Exact ingredient | 2021/11/03 | CDE |
| 布立西坦 | 绍兴京新药业有限公司 | Y20210000729 | I | Exact ingredient | 2021/09/01 | CDE |
| 布立西坦 | Honour Lab Limited, Unit-III | Y20200001316 | I | Exact ingredient | 2021/04/09 | CDE |
| 布立西坦 | 扬子江药业集团江苏海慈生物药业有限公司 | Y20200001212 | I | Exact ingredient | 2021/02/23 | 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: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
-
2026/11/09Accepted
-
2026/11/09Accepted
-
2026/10/28Notification delivery
成都奥邦药业有限公司
CYHS2600146
Fact date: 2026/10/28 (Publication date) · Publication date: 2026/10/28 · Site observation date: 2026/11/03
Notification delivered; the specific outcome remains to be checked.
View source · Table row 19 ↗ -
2026/10/28Notification delivery
成都奥邦药业有限公司
CYHS2600145
Fact date: 2026/10/28 (Publication date) · Publication date: 2026/10/28 · Site observation date: 2026/11/03
Notification delivered; the specific outcome remains to be checked.
View source · Table row 18 ↗ -
2026/10/27No longer listed under review
浙江华海药业股份有限公司
CYHS2600066
Fact date: 2026/10/27 · Site observation date: 2026/10/27
Accepted: 2026/01/08
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/13Accepted
-
2026/10/09Accepted
-
2026/10/09Accepted
-
2026/08/21Accepted
-
2026/08/21Accepted
-
2026/08/21Accepted
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/10 07:27
- Chemical-drug catalogue
- Last successful update: 2026/11/10 07:23
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: 2026/11/10 07:25
- 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: 2026/11/10 18:31
First index-page publication dates: 2026-10-26 to 2026-11-10; 0 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/10 08:10 · 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: 3/30; discovered pending details: 20. 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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