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丙戊酸钠缓释片(I)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 1 application
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 holders14View records ↓
Under-review filings5View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers14View records ↓
API companies with A status16View records ↓
Chemical-drug catalogue
Loaded records: 14 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 14 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 |
|---|---|---|---|---|---|---|
| 重庆药友制药有限责任公司 | 重庆药友制药有限责任公司 | 国药准字H20265773 | 2026/09/02 | 0.5g（按丙戊酸钠计） | 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 |
| 南通联亚药业股份有限公司 | 南通联亚药业股份有限公司 | 国药准字H20265687 | 2026/08/25 | 0.5g（按丙戊酸钠计） | 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 |
| 上海安必生制药技术有限公司 | 江苏安必生制药有限公司 | 国药准字H20265755 | 2026/08/25 | 0.5g（按丙戊酸钠计） | 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 |
| 四川科伦药业股份有限公司 | 四川科伦药业股份有限公司 | 国药准字H20265568 | 2026/08/04 | 0.5g（按丙戊酸钠计） | 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 |
| 山东京卫制药有限公司 | 山东京卫制药有限公司 | 国药准字H20265567 | 2026/08/04 | 0.5g（按丙戊酸钠计） | 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 |
| 锦州奥鸿药业有限责任公司 | 锦州奥鸿药业有限责任公司 | 国药准字H20265494 | 2026/08/04 | 0.5g（按丙戊酸钠计） | 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 |
| 辰欣药业股份有限公司 | 辰欣药业股份有限公司 | 国药准字H20265538 | 2026/08/04 | 0.5g（按丙戊酸钠计） | 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 |
| 山东中健康桥制药有限公司 | 山东中健康桥制药有限公司 | 国药准字H20265354 | 2026/07/28 | 0.5g（按丙戊酸钠计） | 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 |
| 浙江普洛康裕制药有限公司 | 浙江普洛康裕制药有限公司 | 国药准字H20264843 | 2026/06/17 | 0.5g（按丙戊酸钠计） | 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 |
| 华益药业科技（安徽）有限公司 | 华益药业科技（安徽）有限公司 | 国药准字H20264613 | 2026/06/03 | 0.5g（以丙戊酸钠计） | 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 |
| 四川科瑞德制药股份有限公司 | 四川科瑞德制药股份有限公司 | 国药准字H20263449 | 2026/02/25 | 0.5g（按丙戊酸钠计） | 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 |
| 湖南省湘中制药有限公司 | 湖南省湘中制药有限公司 | 国药准字H20249693 | 2024/12/06 | 0.5g（以丙戊酸钠计） | 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H20244732 | 2024/08/27 | 0.5g（以丙戊酸钠计） | 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 |
| 济川药业集团有限公司 | 济川药业集团有限公司 | 国药准字H20266208 | 2026/10/13 | 0.5g（按丙戊酸钠计） | 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: 14 distinct approval numbers and 14 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H20244732 | 0.5g(以丙戊酸钠计) | Category B (乙) | XN03AGB231A010010100177 | NHSA |
| 信东生技股份有限公司 | 国药准字HC20181023 | 0.5g(以丙戊酸钠计) | Category B (乙) | XN03AGB231A010010179160 | NHSA |
| 上海安必生制药技术有限公司 | 国药准字H20265755 | 0.5g(按丙戊酸钠计) | Category B (乙) | XN03AGB231A010010182990 | NHSA |
| 华益药业科技(安徽)有限公司 | 国药准字H20264613 | 0.5g(按丙戊酸钠计) | Category B (乙) | XN03AGB231A010010184212 | NHSA |
| 信东生技股份有限公司 | 国药准字HC20181023 | 0.5g(以丙戊酸钠计) | Category B (乙) | XN03AGB231A010010279160 | NHSA |
| 锦州奥鸿药业有限责任公司 | 国药准字H20265494 | 0.5g(按丙戊酸钠计) | Category B (乙) | XN03AGB231A010010101190 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20265568 | 0.5g(按丙戊酸钠计) | Category B (乙) | XN03AGB231A010010102180 | NHSA |
| 四川科瑞德制药股份有限公司 | 国药准字H20263449 | 0.5g(按丙戊酸钠计) | Category B (乙) | XN03AGB231A010010102181 | NHSA |
| 山东中健康桥制药有限公司 | 国药准字H20265354 | 0.5g(按丙戊酸钠计) | Category B (乙) | XN03AGB231A010010104066 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20265567 | 0.5g(按丙戊酸钠计) | Category B (乙) | XN03AGB231A010010104111 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20265538 | 0.5g(按丙戊酸钠计) | Category B (乙) | XN03AGB231A010010104127 | NHSA |
| 赛诺菲(杭州)制药有限公司 | 国药准字H20010595 | 0.5g(以丙戊酸钠计) | Category B (乙) | XN03AGB231A010010104502 | NHSA |
| 浙江普洛康裕制药有限公司 | 国药准字H20264843 | 0.5g(按丙戊酸钠计) | Category B (乙) | XN03AGB231A010010104685 | NHSA |
| 华润双鹤湘中药业(湖南)有限公司 | 国药准字H20249693 | 0.5g(以丙戊酸钠计) | Category B (乙) | XN03AGB231A010010104971 | NHSA |
| 南通联亚药业股份有限公司 | 国药准字H20265687 | 0.5g(按丙戊酸钠计) | Category B (乙) | XN03AGB231A010010183802 | NHSA |
| 山东中健康桥制药有限公司 | 国药准字H20265354 | 0.5g(按丙戊酸钠计) | Category B (乙) | XN03AGB231A010010204066 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20265538 | 0.5g(按丙戊酸钠计) | Category B (乙) | XN03AGB231A010010204127 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20265538 | 0.5g(按丙戊酸钠计) | Category B (乙) | XN03AGB231A010010304127 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20265538 | 0.5g(按丙戊酸钠计) | Category B (乙) | XN03AGB231A010010404127 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20265538 | 0.5g(按丙戊酸钠计) | Category B (乙) | XN03AGB231A010010504127 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20265538 | 0.5g(按丙戊酸钠计) | Category B (乙) | XN03AGB231A010010604127 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20265538 | 0.5g(按丙戊酸钠计) | Category B (乙) | XN03AGB231A010010704127 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20265538 | 0.5g(按丙戊酸钠计) | Category B (乙) | XN03AGB231A010010804127 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20265538 | 0.5g(按丙戊酸钠计) | Category B (乙) | XN03AGB231A010010904127 | 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: 5 filings and 5 distinct first applicants.
Generic 4 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京泽恒医药技术开发有限公司;江苏亚邦爱普森药业有限公司 | CYHS2600912 | Generic | 2026/04/21 | Not stated by source | CDE |
| 浙江众延医药科技有限公司;浙江诺得药业有限公司 | CYHB2601686 | Supplement | 2026/09/04 | Not stated by source | CDE |
| 浙江诺得药业有限公司 | CYHS2400289 | Generic | 2024/01/20 | Not stated by source | CDE |
| 燃点（南京）生物医药科技有限公司;浙江京新药业股份有限公司 | CYHS2600212 | Generic | 2026/01/20 | Not stated by source | CDE |
| 河北晨光同晟制药有限公司;以岭万洲国际制药有限公司 | CYHS2504200 | Generic | 2025/12/06 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 16 companies with A status and 6 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 |
|---|---|---|---|---|---|---|
| 丙戊酸 | Sun Pharmaceutical Industries Limited | Y20250001033 | I | Salt-normalized ingredient | 2025/09/25 | CDE |
| 丙戊酸 | Sun Pharmaceutical Industries Limited | Y20250000649 | I | Salt-normalized ingredient | 2025/08/18 | CDE |
| 丙戊酸 | 仁和堂药业有限公司 | Y20240000643 | A | Salt-normalized ingredient | 2026/10/14 | CDE |
| 丙戊酸 | 河北晨光同晟制药有限公司 | Y20240000641 | A | Salt-normalized ingredient | 2026/03/26 | CDE |
| 丙戊酸 | 泸州科瑞德制药有限公司 | Y20240000705 | A | Salt-normalized ingredient | 2026/06/10 | CDE |
| 丙戊酸 | 浙江赛默制药有限公司 | Y20240000376 | A | Salt-normalized ingredient | 2025/12/05 | CDE |
| 丙戊酸钠 | 河北晨光同晟制药有限公司 | Y20240000434 | A | Exact ingredient | 2025/12/05 | CDE |
| 丙戊酸钠 | 安徽悦康凯悦制药有限公司 | Y20240000228 | A | Exact ingredient | 2025/09/15 | CDE |
| 丙戊酸 | Sun Pharmaceutical Industries Ltd. | Y20220001212 | I | Salt-normalized ingredient | 2025/05/20 | CDE |
| 丙戊酸 | SCI PHARMTECH, INC. TAOYUAN PLANT | Y20230000276 | A | Salt-normalized ingredient | 2026/07/14 | CDE |
| 丙戊酸钠 | 北京福元医药股份有限公司 | Y20230000085 | A | Exact ingredient | 2024/06/07 | CDE |
| 丙戊酸钠 | 华润双鹤湘中药业（湖南）有限公司 | Y20220001291 | A | Exact ingredient | 2026/07/09 | CDE |
| 丙戊酸 | 北京福元医药股份有限公司 | Y20220001239 | A | Salt-normalized ingredient | 2026/05/20 | CDE |
| 丙戊酸钠 | Anjan Drug Private Limited | Y20220000905 | A | Exact ingredient | 2025/06/26 | CDE |
| 丙戊酸 | 华润双鹤湘中药业（湖南）有限公司 | Y20220000968 | A | Salt-normalized ingredient | 2026/07/09 | CDE |
| 丙戊酸 | Anjan Drug Private Limited | Y20220000132 | A | Salt-normalized ingredient | 2026/11/08 | CDE |
| 丙戊酸钠 | 辽宁药联制药有限公司 | Y20210000551 | A | Exact ingredient | 2023/07/28 | CDE |
| 丙戊酸钠 | SANOFI WINTHROP INDUSTRIE | Y20190009129 | A | Exact ingredient | 2024/09/27 | CDE |
| 丙戊酸钠 | 湖南迪诺制药股份有限公司 | Y20190006806 | A | Exact ingredient | — | CDE |
| 丙戊酸钠 | 泸州科瑞德制药有限公司 | Y20190006765 | A | Exact ingredient | 2026/06/10 | CDE |
| 丙戊酸钠 | 上海青平药业有限公司 | Y20190005803 | A | Exact ingredient | — | CDE |
| 丙戊酸镁 | 湖南迪诺制药股份有限公司 | Y20190004825 | A | Salt-normalized ingredient | — | CDE |
| 丙戊酸钠 | 江苏恒瑞医药股份有限公司 | Y20190004684 | A | Exact ingredient | 2025/08/01 | CDE |
| 丙戊酸钠 | 华润双鹤湘中药业（湖南）有限公司 | Y20190002767 | A | Exact ingredient | 2026/07/09 | CDE |
| 丙戊酸镁 | 华润双鹤湘中药业（湖南）有限公司 | Y20190002766 | A | Salt-normalized ingredient | 2026/07/09 | CDE |
| 丙戊酸钠 | 仁和堂药业有限公司 | Y20190002082 | A | Exact ingredient | 2025/05/16 | CDE |
| 丙戊酸钠 | 山东方明药业集团股份有限公司 | Y20190001586 | A | Exact ingredient | 2024/09/27 | CDE |
| 丙戊酸 | 旭富制药科技股份有限公司桃园厂 | Y20190000512 | I | Salt-normalized ingredient | 2023/03/15 | CDE |
| 丙戊酸钠 | SANOFI CHIMIE | Y20170001920 | I | Exact ingredient | — | CDE |
| 丙戊酸钠 | SCI Pharmtech, Inc. | Y20170000790 | A | Exact ingredient | 2026/02/02 | CDE |
| 丙戊酸钠 | Sun Pharmaceutical Industries Limited | Y20260000650 | I | Exact ingredient | 2026/10/30 | 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.
-
2026/09/04Accepted
浙江众延医药科技有限公司;浙江诺得药业有限公司
CYHB2601686
Fact date: 2026/09/04 · Site observation date: 2026/10/21
View source ↗
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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