Monthly
US$200
Billed every month
Brexpiprazole Orally Disintegrating Tablets(布瑞哌唑口崩片)
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.
Company names, approval identifiers and strengths are retained as recorded in the Chinese sources. Category labels include the original wording for verification.
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 |
|---|---|---|---|---|---|---|
| 北京福元医药股份有限公司 | 北京福元医药股份有限公司 | 国药准字H20265551 | 2026/08/04 | 1mg | 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 |
| 北京福元医药股份有限公司 | 北京福元医药股份有限公司 | 国药准字H20265550 | 2026/08/04 | 2mg | 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 |
| 华益泰康药业股份有限公司 | 华益泰康药业股份有限公司 | 国药准字H20264768 | 2026/06/10 | 2mg | 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 |
| 华益泰康药业股份有限公司 | 华益泰康药业股份有限公司 | 国药准字H20264767 | 2026/06/10 | 1mg | 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 |
| 山东新时代药业有限公司 | 山东新时代药业有限公司 | 国药准字H20264111 | 2026/04/21 | 2mg | 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 |
| 山东新时代药业有限公司 | 山东新时代药业有限公司 | 国药准字H20264082 | 2026/04/21 | 1mg | 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 |
| 山东新时代药业有限公司 | 山东新时代药业有限公司 | 国药准字H20264083 | 2026/04/21 | 0.5mg | 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 |
| 湖南科伦制药有限公司 | 湖南科伦制药有限公司 | 国药准字H20263548 | 2026/03/10 | 1mg | 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 |
| 齐鲁制药有限公司 | 齐鲁制药有限公司 | 国药准字H20263260 | 2026/01/27 | 2mg | 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 |
| 齐鲁制药有限公司 | 齐鲁制药有限公司 | 国药准字H20263259 | 2026/01/27 | 1mg | 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 |
| 齐鲁制药有限公司 | 齐鲁制药有限公司 | 国药准字H20263258 | 2026/01/27 | 0.5mg | 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 |
| 湖南科伦制药有限公司 | 湖南科伦制药有限公司 | 国药准字H20263549 | 2026/03/10 | 2mg | 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 |
| 南京海纳制药有限公司 | 南京海纳制药有限公司 | 国药准字H20266440 | 2026/11/03 | 0.5mg | 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 |
| 南京海纳制药有限公司 | 南京海纳制药有限公司 | 国药准字H20266438 | 2026/11/03 | 2mg | 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 |
| 南京海纳制药有限公司 | 南京海纳制药有限公司 | 国药准字H20266439 | 2026/11/03 | 1mg | 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: 9 distinct approval numbers and 4 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 北京福元医药股份有限公司 | 国药准字H20265551 | 1mg | Not stated by source | XN05AXB266A022010100177 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20264083 | 0.5mg | Not stated by source | XN05AXB266A022010104188 | NHSA |
| 湖南科伦制药有限公司 | 国药准字H20263548 | 1mg | Not stated by source | XN05AXB266A022010104948 | NHSA |
| 华益泰康药业股份有限公司 | 国药准字H20264767 | 1mg | Not stated by source | XN05AXB266A022010105819 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20265551 | 1mg | Not stated by source | XN05AXB266A022010200177 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20264083 | 0.5mg | Not stated by source | XN05AXB266A022010204188 | NHSA |
| 湖南科伦制药有限公司 | 国药准字H20263548 | 1mg | Not stated by source | XN05AXB266A022010204948 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20265551 | 1mg | Not stated by source | XN05AXB266A022010300177 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20264083 | 0.5mg | Not stated by source | XN05AXB266A022010304188 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20265551 | 1mg | Not stated by source | XN05AXB266A022010400177 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20264083 | 0.5mg | Not stated by source | XN05AXB266A022010404188 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20264083 | 0.5mg | Not stated by source | XN05AXB266A022010504188 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20265550 | 2mg | Not stated by source | XN05AXB266A022020100177 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20264082 | 1mg | Not stated by source | XN05AXB266A022020104188 | NHSA |
| 湖南科伦制药有限公司 | 国药准字H20263549 | 2mg | Not stated by source | XN05AXB266A022020104948 | NHSA |
| 华益泰康药业股份有限公司 | 国药准字H20264768 | 2mg | Not stated by source | XN05AXB266A022020105819 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20265550 | 2mg | Not stated by source | XN05AXB266A022020200177 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20264082 | 1mg | Not stated by source | XN05AXB266A022020204188 | NHSA |
| 湖南科伦制药有限公司 | 国药准字H20263549 | 2mg | Not stated by source | XN05AXB266A022020204948 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20265550 | 2mg | Not stated by source | XN05AXB266A022020300177 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20264082 | 1mg | Not stated by source | XN05AXB266A022020304188 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20265550 | 2mg | Not stated by source | XN05AXB266A022020400177 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20264082 | 1mg | Not stated by source | XN05AXB266A022020404188 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20264082 | 1mg | Not stated by source | XN05AXB266A022020504188 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20264111 | 2mg | Not stated by source | XN05AXB266A022030104188 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20264111 | 2mg | Not stated by source | XN05AXB266A022030204188 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20264111 | 2mg | Not stated by source | XN05AXB266A022030304188 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20264111 | 2mg | Not stated by source | XN05AXB266A022030404188 | NHSA |
| 山东新时代药业有限公司 | 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 |
|---|---|---|---|---|---|
| 合肥英太制药有限公司 | CYHS2601963 | Generic | 2026/08/11 | Not stated by source | CDE |
| 合肥英太制药有限公司 | CYHS2601962 | Generic | 2026/08/11 | Not stated by source | CDE |
| 合肥英太制药有限公司 | CYHS2601961 | Generic | 2026/08/11 | Not stated by source | CDE |
| 河北龙海药业股份有限公司 | CYHS2600937 | Generic | 2026/04/23 | Not stated by source | CDE |
| 河北龙海药业股份有限公司 | CYHS2600936 | Generic | 2026/04/23 | Not stated by source | CDE |
| 烟台巨先药业有限公司 | CYHS2503451 | Generic | 2025/09/18 | Not stated by source | CDE |
| 烟台巨先药业有限公司 | CYHS2503450 | Generic | 2025/09/18 | Not stated by source | CDE |
| 杭州和康药业有限公司 | CYHS2501864 | Generic | 2025/05/23 | Not stated by source | CDE |
| 杭州和康药业有限公司 | CYHS2501863 | Generic | 2025/05/23 | Not stated by source | CDE |
| 杭州和康药业有限公司 | 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 |
|---|---|---|---|---|---|
| 合肥英太制药有限公司 | CYHS2601963 | Generic | 2026/08/11 | Not stated by source | CDE |
| 合肥英太制药有限公司 | CYHS2601962 | Generic | 2026/08/11 | Not stated by source | CDE |
| 合肥英太制药有限公司 | CYHS2601961 | Generic | 2026/08/11 | Not stated by source | CDE |
| 河北龙海药业股份有限公司 | CYHS2600937 | Generic | 2026/04/23 | Not stated by source | CDE |
| 河北龙海药业股份有限公司 | 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 | 河北广祥制药有限公司 | Y20260000216 | I | Exact ingredient | 2026/04/07 | CDE |
| 布瑞哌唑 | 湖南一格制药有限公司 | Y20260000066 | I | Exact ingredient | 2026/02/14 | CDE |
| 布瑞哌唑 | 山东信谊制药有限公司 | Y20250001338 | I | Exact ingredient | 2025/12/23 | CDE |
| 布瑞哌唑 | 甘肃海普诺睿创制药有限公司 | Y20250001255 | I | Exact ingredient | 2025/12/10 | CDE |
| 布瑞哌唑 | 乳源东阳光药业有限公司 | Y20250000540 | I | Exact ingredient | 2025/06/06 | CDE |
| 布瑞哌唑 | 云鹏医药集团有限公司 | Y20250000268 | A | Exact ingredient | 2026/08/13 | CDE |
| 布瑞哌唑 | 江苏恩华药业股份有限公司 | Y20250000258 | A | Exact ingredient | 2026/08/06 | CDE |
| 布瑞哌唑 | 广东先强药业有限公司 | Y20250000228 | A | Exact ingredient | 2026/07/28 | CDE |
| 布瑞哌唑 | 华润双鹤湘中药业（湖南）有限公司 | Y20250000127 | A | Exact ingredient | 2026/09/21 | CDE |
| 布瑞哌唑 | 江苏正大丰海制药有限公司 | Y20250000085 | A | Exact ingredient | 2026/06/01 | CDE |
| 布瑞哌唑 | 石药集团欧意药业有限公司 | Y20240001524 | A | Exact ingredient | 2026/07/04 | CDE |
| 布瑞哌唑 | 甘肃皓天医药科技有限责任公司 | Y20240001562 | A | Exact ingredient | 2026/08/13 | CDE |
| 布瑞哌唑 | 重庆圣华曦药业股份有限公司 | Y20240001555 | A | Exact ingredient | 2026/08/24 | CDE |
| 布瑞哌唑 | 山东鲁抗医药股份有限公司 | Y20240001517 | A | Exact ingredient | 2026/10/09 | CDE |
| 布瑞哌唑 | 山东新时代药业有限公司 | Y20240001445 | A | Exact ingredient | 2026/07/21 | CDE |
| 布瑞哌唑 | 北京福元医药股份有限公司 | Y20240001452 | A | Exact ingredient | 2026/04/22 | CDE |
| 布瑞哌唑 | 浙江京圣药业有限公司 | Y20240001143 | A | Exact ingredient | 2026/07/13 | CDE |
| 布瑞哌唑 | 天津泰普制药有限公司 | Y20240000883 | A | Exact ingredient | 2025/12/29 | CDE |
| 布瑞哌唑 | 辽宁北峰药业有限公司 | Y20240000819 | A | Exact ingredient | 2026/03/06 | CDE |
| 布瑞哌唑 | 浙江赛默制药有限公司 | Y20240000877 | A | Exact ingredient | 2026/05/20 | CDE |
| 布瑞哌唑 | 浙江国邦药业有限公司 | Y20240000722 | A | Exact ingredient | 2026/09/13 | CDE |
| 布瑞哌唑 | 浙江华海药业股份有限公司 | Y20240000766 | A | Exact ingredient | 2026/03/19 | CDE |
| 布瑞哌唑 | 四川弘远药业有限公司 | Y20240000696 | A | Exact ingredient | 2026/08/11 | CDE |
| 布瑞哌唑 | 扬子江药业集团江苏海慈生物药业有限公司 | Y20240000533 | A | Exact ingredient | 2025/11/28 | CDE |
| 布瑞哌唑 | 山东辰龙药业有限公司 | Y20240000693 | A | Exact ingredient | 2025/11/14 | CDE |
| 布瑞哌唑 | 山东安弘制药有限公司 | Y20240000591 | A | Exact ingredient | 2025/12/14 | CDE |
| 布瑞哌唑 | 四川青木制药有限公司 | Y20240000436 | A | Exact ingredient | 2025/08/22 | CDE |
| 布瑞哌唑 | 兰西哈三联制药有限公司 | Y20230001153 | A | Exact ingredient | 2026/03/06 | CDE |
| 布瑞哌唑 | 黑龙江珍宝岛药业股份有限公司鸡西分公司 | Y20230000743 | A | Exact ingredient | 2026/03/09 | CDE |
| 布瑞哌唑 | 石家庄龙泽制药股份有限公司 | Y20230000669 | A | Exact ingredient | 2026/02/10 | CDE |
| 布瑞哌唑 | 华东医药（西安）博华制药有限公司 | Y20230000283 | A | Exact ingredient | 2026/06/16 | CDE |
| 布瑞哌唑 | 四川科伦药业股份有限公司 | Y20220000975 | A | Exact ingredient | 2026/08/27 | CDE |
| 布瑞哌唑 | Honour Lab Limited, Unit-Ⅲ | Y20210000838 | A | Exact ingredient | 2026/07/04 | CDE |
| 布瑞哌唑 | 山东特珐曼药业有限公司 | Y20210000803 | A | Exact ingredient | 2026/06/18 | CDE |
| 布瑞哌唑 | 湖南洞庭药业股份有限公司 | 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: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
-
2026/11/03Marketing application approved
南京海纳制药有限公司
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
南京海纳制药有限公司
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
南京海纳制药有限公司
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: 2026/11/10 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.
Free follow
Follow changes to Brexpiprazole Orally Disintegrating Tablets
Up to 3 drugs per email address, in one weekly digest. Starts after email confirmation; unsubscribe at any time.
Subscriptions
Next-day facts and deliverable timelines
- One email the next day when new facts are collected for your followed products.
- Export the complete loaded event timeline for each followed product as CSV.
- Add up to 4 additional recipients, each confirmed by email.
- Increase your follow limit from 3 to 10 products.
Quarterly
US$540
Billed every three months
US$180 per month
Yearly
US$1,920
Billed every year
US$160 per month
Online subscriptions are not enabled. The form below registers interest; it does not charge or activate access.
Separate one-time purchase
US Orange Book × China records comparison
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
Subscriptions and comparison-table access are purchased separately. Neither includes the other.
US$490
One payment · 12 months of access
Online comparison-table purchase is not enabled.
Billed by Creem, our merchant of record · Terms · Refund policy