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As of 13 November 2026, for Thioctic Acid Tablets, 4 applications are listed as under review at China's CDE; 3 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 10 holders.
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.
Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.
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 |
|---|---|---|---|---|---|---|
| Jiangsu He Chen Pharma Co., Ltd. romanized | Jiangsu He Chen Pharma Co., Ltd. romanized | 国药准字H20264730 | 2026/06/10 | 0.2g | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu He Chen Pharma Co., Ltd. romanized | Jiangsu He Chen Pharma Co., Ltd. romanized | 国药准字H20264729 | 2026/06/10 | 0.6g | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Lu Ning Pharma Co., Ltd. romanized | Shandong Lu Ning Pharma Co., Ltd. romanized | 国药准字H20264731 | 2026/06/10 | 0.2g | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Lu Ning Pharma Co., Ltd. romanized | Shandong Lu Ning Pharma Co., Ltd. romanized | 国药准字H20264732 | 2026/06/10 | 0.6g | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Wan He Pharmaceutical Co., Ltd. romanized | Jiangsu Wan He Pharmaceutical Co., Ltd. romanized | 国药准字H20263230 | 2026/01/27 | 0.2g | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Wan He Pharmaceutical Co., Ltd. romanized | Jiangsu Wan He Pharmaceutical Co., Ltd. romanized | 国药准字H20263231 | 2026/01/27 | 0.6g | Generic approved under the new chemical-drug registration classification | CDE |
| Suzhou Fu Shi Lai Pharmaceuticals Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20256163 | 2025/12/03 | 0.2g | Not stated by source | CDE |
| Suzhou Fu Shi Lai Pharmaceuticals Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20256164 | 2025/12/03 | 0.6g | Not stated by source | CDE |
| Zhejiang Hua Yuan Pharma Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20255092 | 2025/08/19 | 0.6g | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Hua Yuan Pharma Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20255091 | 2025/08/19 | 0.2g | Generic approved under the new chemical-drug registration classification | CDE |
| Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized | Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized | 国药准字H20254844 | 2025/07/15 | 0.2g | Generic approved under the new chemical-drug registration classification | CDE |
| Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized | Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized | 国药准字H20254843 | 2025/07/15 | 0.6g | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20254560 | 2025/06/17 | 0.6g | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20253712 | 2025/03/25 | 0.6g | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20253713 | 2025/03/25 | 0.2g | Generic approved under the new chemical-drug registration classification | CDE |
| Ya Bao Pharma Group Co., Ltd. romanized | Ya Bao Pharma Group Co., Ltd. romanized | 国药准字H20234571 | 2023/11/28 | 0.6g | Generic approved under the new chemical-drug registration classification | CDE |
| Ya Bao Pharma Group Co., Ltd. romanized | Ya Bao Pharma Group Co., Ltd. romanized | 国药准字H20234570 | 2023/11/28 | 0.2g | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20266515 | 2026/11/03 | 0.6g | Generic approved under the new chemical-drug registration classification | 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 |
|---|---|---|---|---|---|
| Jiangsu Wan He Pharmaceutical Co., Ltd. romanized | 国药准字H20263231 | 0.6g | Not stated by source | XA16AXL154A001010101502 | NHSA |
| Ya Bao Pharma Group Co., Ltd. romanized | 国药准字H20234570 | 0.2g | Not stated by source | XA16AXL154A001010102959 | NHSA |
| Shandong Lu Ning Pharma Co., Ltd. romanized | 国药准字H20264731 | 0.2g | Not stated by source | XA16AXL154A001010104104 | NHSA |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20100152 | 0.3g | Not stated by source | XA16AXL154A001010104145 | NHSA |
| Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized | 国药准字H20254844 | 0.2g | Not stated by source | XA16AXL154A001010104251 | NHSA |
| Zhejiang Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20255091 | 0.2g | Not stated by source | XA16AXL154A001010104646 | NHSA |
| Suzhou Fu Shi Lai Pharmaceuticals Co., Ltd. romanized | 国药准字H20256163 | 0.2g | Not stated by source | XA16AXL154A001010180542 | NHSA |
| Jiangsu He Chen Pharma Co., Ltd. romanized | 国药准字H20264730 | 0.2g | Not stated by source | XA16AXL154A001010183879 | NHSA |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20253713 | 0.2g | Not stated by source | XA16AXL154A001010184106 | NHSA |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254560 | 0.6g | Not stated by source | XA16AXL154A001010184211 | NHSA |
| Jiangsu Wan He Pharmaceutical Co., Ltd. romanized | 国药准字H20263231 | 0.6g | Not stated by source | XA16AXL154A001010201502 | NHSA |
| Ya Bao Pharma Group Co., Ltd. romanized | 国药准字H20234570 | 0.2g | Not stated by source | XA16AXL154A001010202959 | NHSA |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20100152 | 0.3g | Not stated by source | XA16AXL154A001010204145 | NHSA |
| Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized | 国药准字H20254844 | 0.2g | Not stated by source | XA16AXL154A001010204251 | NHSA |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20253713 | 0.2g | Not stated by source | XA16AXL154A001010284106 | NHSA |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254560 | 0.6g | Not stated by source | XA16AXL154A001010284211 | NHSA |
| Jiangsu Wan He Pharmaceutical Co., Ltd. romanized | 国药准字H20263231 | 0.6g | Not stated by source | XA16AXL154A001010301502 | NHSA |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20253713 | 0.2g | Not stated by source | XA16AXL154A001010384106 | NHSA |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254560 | 0.6g | Not stated by source | XA16AXL154A001010384211 | NHSA |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20253713 | 0.2g | Not stated by source | XA16AXL154A001010484106 | NHSA |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254560 | 0.6g | Not stated by source | XA16AXL154A001010484211 | NHSA |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20253713 | 0.2g | Not stated by source | XA16AXL154A001010584106 | NHSA |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254560 | 0.6g | Not stated by source | XA16AXL154A001010584211 | NHSA |
| Jiangsu Wan He Pharmaceutical Co., Ltd. romanized | 国药准字H20263230 | 0.2g | Not stated by source | XA16AXL154A001020101502 | NHSA |
| Ya Bao Pharma Group Co., Ltd. romanized | 国药准字H20234571 | 0.6g | Not stated by source | XA16AXL154A001020102959 | NHSA |
| Shandong Lu Ning Pharma Co., Ltd. romanized | 国药准字H20264732 | 0.6g | Not stated by source | XA16AXL154A001020104104 | NHSA |
| Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized | 国药准字H20254843 | 0.6g | Not stated by source | XA16AXL154A001020104251 | NHSA |
| Zhejiang Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20255092 | 0.6g | Not stated by source | XA16AXL154A001020104646 | NHSA |
| Suzhou Fu Shi Lai Pharmaceuticals Co., Ltd. romanized | 国药准字H20256164 | 0.6g | Not stated by source | XA16AXL154A001020180542 | NHSA |
| Jiangsu He Chen Pharma Co., Ltd. romanized | 国药准字H20264729 | 0.6g | Not stated by source | XA16AXL154A001020183879 | NHSA |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20253712 | 0.6g | Not stated by source | XA16AXL154A001020184106 | NHSA |
| Ya Bao Pharma Group Co., Ltd. romanized | 国药准字H20234571 | 0.6g | Not stated by source | XA16AXL154A001020202959 | NHSA |
| Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized | 国药准字H20254843 | 0.6g | Not stated by source | XA16AXL154A001020204251 | NHSA |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20253712 | 0.6g | Not stated by source | XA16AXL154A001020284106 | NHSA |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 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 |
|---|---|---|---|---|---|
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | CYHS2602451 | Generic | 2026/10/09 | Not stated by source | CDE |
| Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized | CYHS2602051 | Generic | 2026/08/19 | Not stated by source | CDE |
| Beijing SL Pharmaceutical Co., Ltd. | CYHS2601259 | Generic | 2026/06/04 | Not stated by source | CDE |
| Shandong Qidu Pharmaceutical Co., Ltd. | 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 |
|---|---|---|---|---|---|
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | CYHS2602451 | Generic | 2026/10/09 | Not stated by source | CDE |
| Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized | CYHS2602051 | Generic | 2026/08/19 | Not stated by source | CDE |
| Beijing SL Pharmaceutical Co., Ltd. | 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 · No verified English name | Lu Nan Xin Shi Dai Bio Technology Co., Ltd. romanized | Y20260000364 | I | Exact ingredient | 2026/05/13 | CDE |
| 硫辛酸 · No verified English name | AMI LIFESCIENCES PVT. LTD. | Y20240000921 | I | Exact ingredient | 2024/12/24 | CDE |
| 硫辛酸 · No verified English name | Shandong Lu Ning Pharma Co., Ltd. romanized | Y20230000541 | A | Exact ingredient | 2026/02/07 | CDE |
| 硫辛酸 · No verified English name | Guang An Kai Te Pharmaceutical Co., Ltd. romanized | Y20210000898 | A | Exact ingredient | 2023/06/21 | CDE |
| 硫辛酸 · No verified English name | Guo Yao Group Wei Qi Da Pharma Co., Ltd. romanized | Y20190021622 | A | Exact ingredient | 2026/07/29 | CDE |
| 硫辛酸 · No verified English name | Qingdao Jin Feng Pharmaceutical Co., Ltd. romanized | Y20190007208 | A | Exact ingredient | — | CDE |
| 硫辛酸 · No verified English name | Jiangsu Tong He Pharma Co., Ltd. romanized | Y20190006792 | A | Exact ingredient | 2024/01/17 | CDE |
| 硫辛酸 · No verified English name | Suzhou Fu Shi Lai Pharmaceuticals Co., Ltd. romanized | Y20190006576 | A | Exact ingredient | 2026/07/17 | CDE |
| 硫辛酸 · No verified English name | Wuhan Bio Chemical Pharmaceutical Co., Ltd. romanized | Y20190006326 | A | Exact ingredient | 2026/02/06 | CDE |
| 硫辛酸 · No verified English name | Dan Dong Yi Chuang Pharma Co., Ltd. romanized | Y20190006301 | A | Exact ingredient | 2025/09/13 | CDE |
| 硫辛酸 · No verified English name | YaoPharma Co., Ltd. | Y20190006137 | A | Exact ingredient | 2025/12/16 | CDE |
| 硫辛酸 · No verified English name | Ya Bao Pharma Group Co., Ltd. romanized | Y20190004580 | A | Exact ingredient | 2026/01/08 | CDE |
| 硫辛酸 · No verified English name | Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | Y20190004123 | A | Exact ingredient | 2023/03/24 | CDE |
| 硫辛酸 · No verified English name | Jiangsu Shen Long Pharma Co., Ltd. romanized | Y20190003078 | A | Exact ingredient | — | CDE |
| 硫辛酸 · No verified English name | Shanghai Shyndec Pharmaceutical Co., Ltd. | Y20190002414 | A | Exact ingredient | — | CDE |
| 硫辛酸 · No verified English name | Shandong Qidu Pharmaceutical Co., Ltd. | Y20190002067 | A | Exact ingredient | 2024/11/29 | CDE |
| 硫辛酸 · No verified English name | Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized | Y20190001222 | A | Exact ingredient | — | CDE |
| 硫辛酸 · No verified English name | 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: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.
-
2026/11/03Marketing application approved
Shandong Xin Shi Dai Pharma Co., Ltd. romanized
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
Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized
CYHS2602451
Fact date: 2026/10/09 · Site observation date: 2026/10/22
View source ↗ -
2026/08/19Accepted
Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized
CYHS2602051
Fact date: 2026/08/19 · Site observation date: 2026/10/22
View source ↗
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/13 06:42
- Chemical-drug catalogue
- Last successful update: 2026/11/13 06:39
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: 2026/11/13 06:41
- 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: 2026/11/12 18:32 · Current coverage may be incomplete
First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/13 08:09 · 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: 7/30; discovered pending details: 13. 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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