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布美他尼片
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 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 filings8View records ↓
This year’s generic filers4View records ↓
NHSA approval numbers7View records ↓
API companies with A status24View 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 |
|---|---|---|---|---|---|---|
| 杭州沐源生物医药科技股份有限公司 | 新乡市常乐制药有限责任公司 | 国药准字H20263917 | 2026/04/14 | 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: 7 distinct approval numbers and 7 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 北京市燕京药业有限公司 | 国药准字H11020433 | 1mg | Category B (乙) | XC03CAB176A001010100135 | NHSA |
| 西南药业股份有限公司 | 国药准字H50020051 | 1mg | Category B (乙) | XC03CAB176A001010100978 | NHSA |
| 福州海王福药制药有限公司 | 国药准字H35020503 | 1mg | Category B (乙) | XC03CAB176A001010104827 | NHSA |
| 康普药业股份有限公司 | 国药准字H43021533 | 1mg | Category B (乙) | XC03CAB176A001010105009 | NHSA |
| 桂林南药股份有限公司 | 国药准字H45020938 | 1mg | Category B (乙) | XC03CAB176A001010105206 | NHSA |
| 杭州沐源生物医药科技股份有限公司 | 国药准字H20263917 | 1mg | Category B (乙) | XC03CAB176A001010184135 | NHSA |
| 宁波大红鹰药业股份有限公司 | 国药准字H33020356 | 1mg | Category B (乙) | XC03CAB176A001010204554 | NHSA |
| 宁波大红鹰药业股份有限公司 | 国药准字H33020356 | 1mg | Category B (乙) | XC03CAB176A001010304554 | NHSA |
| 桂林南药股份有限公司 | 国药准字H45020938 | 1mg | Category B (乙) | XC03CAB176A001010505206 | NHSA |
| 康普药业股份有限公司 | 国药准字H43021533 | 1mg | Category B (乙) | XC03CAB176A001020105009 | 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: 8 filings and 7 distinct first applicants.
Generic 7 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏润恒制药有限公司 | CYHS2601736 | Generic | 2026/07/20 | Not stated by source | CDE |
| 福建海西新药创制股份有限公司 | CYHS2602476 | Generic | 2026/10/10 | Not stated by source | CDE |
| 成都瑞尔医药科技有限公司;广州绿十字制药股份有限公司 | CYHS2601746 | Generic | 2026/07/21 | Not stated by source | CDE |
| 宁波大红鹰药业股份有限公司 | CYHB2650065 | Supplement | 2026/02/26 | Not stated by source | CDE |
| 成都新恒创药业有限公司;四川赛卓药业股份有限公司 | CYHS2503490 | Generic | 2025/09/23 | Not stated by source | CDE |
| 中山万汉制药有限公司 | CYHS2501478 | Generic | 2025/04/18 | Not stated by source | CDE |
| 中山万汉制药有限公司 | CYHS2501477 | Generic | 2025/04/18 | Not stated by source | CDE |
| 浙江皓格药业有限公司 | CYHS2602749 | Generic | 2026/11/09 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 4 filings and 4 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏润恒制药有限公司 | CYHS2601736 | Generic | 2026/07/20 | Not stated by source | CDE |
| 福建海西新药创制股份有限公司 | CYHS2602476 | Generic | 2026/10/10 | Not stated by source | CDE |
| 成都瑞尔医药科技有限公司;广州绿十字制药股份有限公司 | CYHS2601746 | Generic | 2026/07/21 | Not stated by source | CDE |
| 浙江皓格药业有限公司 | CYHS2602749 | Generic | 2026/11/09 | Not stated by source | CDE |
API registrations
Non-component matches: 24 companies with A status and 3 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 |
|---|---|---|---|---|---|---|
| 布美他尼 | 宜昌天睿生物医药有限责任公司 | Y20260000184 | I | Exact ingredient | 2026/04/23 | CDE |
| 布美他尼 | 浙江赛默制药有限公司 | Y20240000927 | A | Exact ingredient | 2026/07/13 | CDE |
| 布美他尼 | 绪必迪药业（沧州）有限公司 | Y20240001294 | A | Exact ingredient | 2026/05/07 | CDE |
| 布美他尼 | 河北国龙制药有限公司 | Y20240001211 | A | Exact ingredient | 2026/07/15 | CDE |
| 布美他尼 | 海南普利制药股份有限公司 | Y20240001076 | A | Exact ingredient | 2026/04/01 | CDE |
| 布美他尼 | 山东方明药业集团股份有限公司 | Y20240000859 | A | Exact ingredient | 2026/04/21 | CDE |
| 布美他尼 | 酒泉大得利制药股份有限公司 | Y20240000936 | A | Exact ingredient | 2026/07/01 | CDE |
| 布美他尼 | 杭州澳赛诺生物科技有限公司 | Y20240000761 | A | Exact ingredient | 2026/03/17 | CDE |
| 布美他尼 | 福建南方制药股份有限公司 | Y20240000807 | A | Exact ingredient | 2026/01/08 | CDE |
| 布美他尼 | 山东辰龙药业有限公司 | Y20240000775 | A | Exact ingredient | 2026/06/23 | CDE |
| 布美他尼 | 福建南方制药股份有限公司 | Y20240000623 | I | Exact ingredient | 2024/08/05 | CDE |
| 布美他尼 | 苏州立新制药有限公司 | Y20240000515 | A | Exact ingredient | 2025/11/26 | CDE |
| 布美他尼 | OLON S.P.A. | Y20240000359 | A | Exact ingredient | 2025/12/05 | CDE |
| 布美他尼 | 浙江皓华制药有限公司 | Y20240000188 | A | Exact ingredient | 2025/05/28 | CDE |
| 布美他尼 | 安徽恒星制药有限公司 | Y20230001167 | A | Exact ingredient | 2025/07/01 | CDE |
| 布美他尼 | 海南卓科制药有限公司 | Y20230001090 | A | Exact ingredient | 2025/07/18 | CDE |
| 布美他尼 | INDUSTRIALE CHIMICA S.R.L. | Y20230000563 | A | Exact ingredient | 2026/09/13 | CDE |
| 布美他尼 | 江苏云阳集团药业有限公司 | Y20230000614 | A | Exact ingredient | 2024/11/07 | CDE |
| 布美他尼 | 四川青木制药有限公司 | Y20230000354 | A | Exact ingredient | 2026/03/03 | CDE |
| 布美他尼 | 宿州亿帆药业有限公司 | Y20230000386 | A | Exact ingredient | 2025/06/07 | CDE |
| 布美他尼 | 中山万汉制药有限公司 | Y20230000272 | A | Exact ingredient | 2026/08/15 | CDE |
| 布美他尼 | 成都新恒创药业有限公司 | Y20220001296 | A | Exact ingredient | 2026/01/22 | CDE |
| 布美他尼 | Solara Active Pharma Sciences Limited | Y20210001128 | I | Exact ingredient | 2022/02/23 | CDE |
| 布美他尼 | 丹东医创药业有限责任公司 | Y20190007367 | A | Exact ingredient | — | CDE |
| 布美他尼 | 桂林南药股份有限公司 | Y20190004090 | A | Exact ingredient | 2025/01/18 | CDE |
| 布美他尼 | 海南吾仁制药有限公司 | Y20190002887 | A | Exact ingredient | 2024/09/05 | CDE |
| 布美他尼 | 宁波大红鹰药业股份有限公司 | Y20190002459 | A | Exact ingredient | 2025/01/03 | 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.
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2026/11/09Accepted
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2026/10/10Accepted
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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