Monthly
US$200
Billed every month
Thioctic Acid Tablets(硫辛酸片)
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 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 holders10View records ↓
Under-review filings4View records ↓
This year’s generic filers3View records ↓
NHSA approval numbers18View records ↓
API companies with A status15View records ↓
Chemical-drug catalogue
Loaded records: 10 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 9 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 |
|---|---|---|---|---|---|---|
| 江苏和晨药业有限公司 | 江苏和晨药业有限公司 | 国药准字H20264730 | 2026/06/10 | 0.2g | 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 |
| 江苏和晨药业有限公司 | 江苏和晨药业有限公司 | 国药准字H20264729 | 2026/06/10 | 0.6g | 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 |
| 山东鲁宁药业有限公司 | 山东鲁宁药业有限公司 | 国药准字H20264731 | 2026/06/10 | 0.2g | 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 |
| 山东鲁宁药业有限公司 | 山东鲁宁药业有限公司 | 国药准字H20264732 | 2026/06/10 | 0.6g | 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 |
| 江苏万禾制药有限公司 | 江苏万禾制药有限公司 | 国药准字H20263230 | 2026/01/27 | 0.2g | 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 |
| 江苏万禾制药有限公司 | 江苏万禾制药有限公司 | 国药准字H20263231 | 2026/01/27 | 0.6g | 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 |
| 苏州富士莱医药股份有限公司 | 浙江赛默制药有限公司 | 国药准字H20256163 | 2025/12/03 | 0.2g | Not stated by source | CDE |
| 苏州富士莱医药股份有限公司 | 浙江赛默制药有限公司 | 国药准字H20256164 | 2025/12/03 | 0.6g | Not stated by source | CDE |
| 浙江花园药业有限公司 | 浙江赛默制药有限公司 | 国药准字H20255092 | 2025/08/19 | 0.6g | 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 |
| 浙江花园药业有限公司 | 浙江赛默制药有限公司 | 国药准字H20255091 | 2025/08/19 | 0.2g | 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 |
| 福安药业集团烟台只楚药业有限公司 | 福安药业集团烟台只楚药业有限公司 | 国药准字H20254844 | 2025/07/15 | 0.2g | 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 |
| 福安药业集团烟台只楚药业有限公司 | 福安药业集团烟台只楚药业有限公司 | 国药准字H20254843 | 2025/07/15 | 0.6g | 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 |
| 浙江百代医药科技有限公司 | 浙江赛默制药有限公司 | 国药准字H20254560 | 2025/06/17 | 0.6g | 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 |
| 湖南先施制药有限公司 | 浙江赛默制药有限公司 | 国药准字H20253712 | 2025/03/25 | 0.6g | 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 |
| 湖南先施制药有限公司 | 浙江赛默制药有限公司 | 国药准字H20253713 | 2025/03/25 | 0.2g | 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 |
| 亚宝药业集团股份有限公司 | 亚宝药业集团股份有限公司 | 国药准字H20234571 | 2023/11/28 | 0.6g | 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 |
| 亚宝药业集团股份有限公司 | 亚宝药业集团股份有限公司 | 国药准字H20234570 | 2023/11/28 | 0.2g | 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H20266515 | 2026/11/03 | 0.6g | 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: 18 distinct approval numbers and 10 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 江苏万禾制药有限公司 | 国药准字H20263231 | 0.6g | Not stated by source | XA16AXL154A001010101502 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20234570 | 0.2g | Not stated by source | XA16AXL154A001010102959 | NHSA |
| 山东鲁宁药业有限公司 | 国药准字H20264731 | 0.2g | Not stated by source | XA16AXL154A001010104104 | NHSA |
| 山东齐都药业有限公司 | 国药准字H20100152 | 0.3g | Not stated by source | XA16AXL154A001010104145 | NHSA |
| 福安药业集团烟台只楚药业有限公司 | 国药准字H20254844 | 0.2g | Not stated by source | XA16AXL154A001010104251 | NHSA |
| 浙江花园药业有限公司 | 国药准字H20255091 | 0.2g | Not stated by source | XA16AXL154A001010104646 | NHSA |
| 苏州富士莱医药股份有限公司 | 国药准字H20256163 | 0.2g | Not stated by source | XA16AXL154A001010180542 | NHSA |
| 江苏和晨药业有限公司 | 国药准字H20264730 | 0.2g | Not stated by source | XA16AXL154A001010183879 | NHSA |
| 湖南先施制药有限公司 | 国药准字H20253713 | 0.2g | Not stated by source | XA16AXL154A001010184106 | NHSA |
| 浙江百代医药科技有限公司 | 国药准字H20254560 | 0.6g | Not stated by source | XA16AXL154A001010184211 | NHSA |
| 江苏万禾制药有限公司 | 国药准字H20263231 | 0.6g | Not stated by source | XA16AXL154A001010201502 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20234570 | 0.2g | Not stated by source | XA16AXL154A001010202959 | NHSA |
| 山东齐都药业有限公司 | 国药准字H20100152 | 0.3g | Not stated by source | XA16AXL154A001010204145 | NHSA |
| 福安药业集团烟台只楚药业有限公司 | 国药准字H20254844 | 0.2g | Not stated by source | XA16AXL154A001010204251 | NHSA |
| 湖南先施制药有限公司 | 国药准字H20253713 | 0.2g | Not stated by source | XA16AXL154A001010284106 | NHSA |
| 浙江百代医药科技有限公司 | 国药准字H20254560 | 0.6g | Not stated by source | XA16AXL154A001010284211 | NHSA |
| 江苏万禾制药有限公司 | 国药准字H20263231 | 0.6g | Not stated by source | XA16AXL154A001010301502 | NHSA |
| 湖南先施制药有限公司 | 国药准字H20253713 | 0.2g | Not stated by source | XA16AXL154A001010384106 | NHSA |
| 浙江百代医药科技有限公司 | 国药准字H20254560 | 0.6g | Not stated by source | XA16AXL154A001010384211 | NHSA |
| 湖南先施制药有限公司 | 国药准字H20253713 | 0.2g | Not stated by source | XA16AXL154A001010484106 | NHSA |
| 浙江百代医药科技有限公司 | 国药准字H20254560 | 0.6g | Not stated by source | XA16AXL154A001010484211 | NHSA |
| 湖南先施制药有限公司 | 国药准字H20253713 | 0.2g | Not stated by source | XA16AXL154A001010584106 | NHSA |
| 浙江百代医药科技有限公司 | 国药准字H20254560 | 0.6g | Not stated by source | XA16AXL154A001010584211 | NHSA |
| 江苏万禾制药有限公司 | 国药准字H20263230 | 0.2g | Not stated by source | XA16AXL154A001020101502 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20234571 | 0.6g | Not stated by source | XA16AXL154A001020102959 | NHSA |
| 山东鲁宁药业有限公司 | 国药准字H20264732 | 0.6g | Not stated by source | XA16AXL154A001020104104 | NHSA |
| 福安药业集团烟台只楚药业有限公司 | 国药准字H20254843 | 0.6g | Not stated by source | XA16AXL154A001020104251 | NHSA |
| 浙江花园药业有限公司 | 国药准字H20255092 | 0.6g | Not stated by source | XA16AXL154A001020104646 | NHSA |
| 苏州富士莱医药股份有限公司 | 国药准字H20256164 | 0.6g | Not stated by source | XA16AXL154A001020180542 | NHSA |
| 江苏和晨药业有限公司 | 国药准字H20264729 | 0.6g | Not stated by source | XA16AXL154A001020183879 | NHSA |
| 湖南先施制药有限公司 | 国药准字H20253712 | 0.6g | Not stated by source | XA16AXL154A001020184106 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20234571 | 0.6g | Not stated by source | XA16AXL154A001020202959 | NHSA |
| 福安药业集团烟台只楚药业有限公司 | 国药准字H20254843 | 0.6g | Not stated by source | XA16AXL154A001020204251 | NHSA |
| 湖南先施制药有限公司 | 国药准字H20253712 | 0.6g | Not stated by source | XA16AXL154A001020284106 | NHSA |
| 湖南先施制药有限公司 | 国药准字H20253712 | 0.6g | Not stated by source | XA16AXL154A001020384106 | 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: 4 filings and 4 distinct first applicants.
Generic 3 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 石家庄市华新药业有限责任公司 | CYHS2602451 | Generic | 2026/10/09 | Not stated by source | CDE |
| 广东健信制药股份有限公司 | CYHS2602051 | Generic | 2026/08/19 | Not stated by source | CDE |
| 北京双鹭药业股份有限公司 | CYHS2601259 | Generic | 2026/06/04 | Not stated by source | CDE |
| 山东齐都药业有限公司 | CYHB2550386 | Supplement | 2025/12/09 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 3 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 石家庄市华新药业有限责任公司 | CYHS2602451 | Generic | 2026/10/09 | Not stated by source | CDE |
| 广东健信制药股份有限公司 | CYHS2602051 | Generic | 2026/08/19 | Not stated by source | CDE |
| 北京双鹭药业股份有限公司 | CYHS2601259 | Generic | 2026/06/04 | Not stated by source | CDE |
API registrations
Non-component matches: 15 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 |
|---|---|---|---|---|---|---|
| 硫辛酸 | 鲁南新时代生物技术有限公司 | Y20260000364 | I | Exact ingredient | 2026/05/13 | CDE |
| 硫辛酸 | AMI LIFESCIENCES PVT. LTD. | Y20240000921 | I | Exact ingredient | 2024/12/24 | CDE |
| 硫辛酸 | 山东鲁宁药业有限公司 | Y20230000541 | A | Exact ingredient | 2026/02/07 | CDE |
| 硫辛酸 | 广安凯特制药有限公司 | Y20210000898 | A | Exact ingredient | 2023/06/21 | CDE |
| 硫辛酸 | 国药集团威奇达药业有限公司 | Y20190021622 | A | Exact ingredient | 2026/07/29 | CDE |
| 硫辛酸 | 青岛金峰制药有限公司 | Y20190007208 | A | Exact ingredient | — | CDE |
| 硫辛酸 | 江苏同禾药业有限公司 | Y20190006792 | A | Exact ingredient | 2024/01/17 | CDE |
| 硫辛酸 | 苏州富士莱医药股份有限公司 | Y20190006576 | A | Exact ingredient | 2026/07/17 | CDE |
| 硫辛酸 | 武汉生物化学制药有限公司 | Y20190006326 | A | Exact ingredient | 2026/02/06 | CDE |
| 硫辛酸 | 丹东医创药业有限责任公司 | Y20190006301 | A | Exact ingredient | 2025/09/13 | CDE |
| 硫辛酸 | 重庆药友制药有限责任公司 | Y20190006137 | A | Exact ingredient | 2025/12/16 | CDE |
| 硫辛酸 | 亚宝药业集团股份有限公司 | Y20190004580 | A | Exact ingredient | 2026/01/08 | CDE |
| 硫辛酸 | 北京四环科宝制药股份有限公司 | Y20190004123 | A | Exact ingredient | 2023/03/24 | CDE |
| 硫辛酸 | 江苏神龙药业股份有限公司 | Y20190003078 | A | Exact ingredient | — | CDE |
| 硫辛酸 | 上海现代制药股份有限公司 | Y20190002414 | A | Exact ingredient | — | CDE |
| 硫辛酸 | 山东齐都药业有限公司 | Y20190002067 | A | Exact ingredient | 2024/11/29 | CDE |
| 硫辛酸 | 福安药业集团烟台只楚药业有限公司 | Y20190001222 | A | Exact ingredient | — | CDE |
| 硫辛酸 | Olon S.p.A. | Y20190000265 | I | Exact ingredient | 2019/04/08 | 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
山东新时代药业有限公司
CYHS2501735 · 国药准字H20266515
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 73 ↗ -
2026/10/09Accepted
-
2026/08/19Accepted
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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