Monthly
US$200
Billed every month
Tranexamic Acid Tablets(氨甲环酸片)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 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 holders10View records ↓
Under-review filings11View records ↓
This year’s generic filers5View records ↓
NHSA approval numbers13View records ↓
API companies with A status15View records ↓
Chemical-drug catalogue
Loaded records: 10 holders; 1 in the quality-and-efficacy consistency-evaluation category, and 8 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 |
|---|---|---|---|---|---|---|
| 成都倍特药业股份有限公司 | 成都倍特药业股份有限公司 | 国药准字H20264299 | 2026/05/12 | 0.25g | 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 |
| 浙江兄弟药业有限公司 | 华益药业科技（安徽）有限公司 | 国药准字H20264055 | 2026/04/21 | 0.5g | 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 |
| 石家庄四药有限公司 | 石家庄四药有限公司 | 国药准字H20263816 | 2026/03/31 | 0.25g | 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 |
| 浙江赛默制药有限公司 | 浙江赛默制药有限公司 | 国药准字H20263466 | 2026/02/25 | 0.5g | 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 |
| 江苏知原药业股份有限公司 | 江苏知原药业股份有限公司 | 国药准字H20263108 | 2026/01/14 | 0.25g | 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 |
| 海南药谷云生物科技有限公司 | 北京北陆药业股份有限公司 | 国药准字H20256156 | 2025/12/03 | 0.5g | 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 |
| 杭州康恩贝制药有限公司 | 杭州康恩贝制药有限公司 | 国药准字H20255025 | 2025/07/29 | 0.25g | 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 |
| 烟台万润药业有限公司 | 烟台万润药业有限公司 | 国药准字H20234646 | 2023/12/13 | 0.25g | 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 |
| 湖南洞庭药业股份有限公司 | 湖南洞庭药业股份有限公司 | 国药准字H43020564 | 2023/10/30 | 0.25g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 第一三共株式会社 | CMIC CMO CO.,LTD.Shizuoka Plant | H20160282 | 2000/10/07 | 0.5g | Imported originator drug (进口原研药品) | 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: 13 distinct approval numbers and 12 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 海南药谷云生物科技有限公司 | 国药准字H20256156 | 0.5g | Category B (乙) | XB02AAA172A001010100014 | NHSA |
| 上海信谊万象药业股份有限公司 | 国药准字H31020040 | 0.25g | Category B (乙) | XB02AAA172A001010100804 | NHSA |
| 成都倍特药业股份有限公司 | 国药准字H20264299 | 0.25g | Category B (乙) | XB02AAA172A001010102013 | NHSA |
| 石家庄四药有限公司 | 国药准字H20253413 | 0.5g | Category B (乙) | XB02AAA172A001010102763 | NHSA |
| 上海凯宝新谊(新乡)药业有限公司 | 国药准字H41021481 | 0.125g | Category B (乙) | XB02AAA172A001010103085 | NHSA |
| 吉林万通药业集团郑州万通复升药业股份有限公司 | 国药准字H41025628 | 0.125g | Category B (乙) | XB02AAA172A001010103250 | NHSA |
| 烟台万润药业有限公司 | 国药准字H20234646 | 0.25g | Category B (乙) | XB02AAA172A001010104223 | NHSA |
| 杭州康恩贝制药有限公司 | 国药准字H20255025 | 0.25g | Category B (乙) | XB02AAA172A001010104489 | NHSA |
| 湖南洞庭药业股份有限公司 | 国药准字H43020564 | 0.25g | Category B (乙) | XB02AAA172A001010104917 | NHSA |
| 国药集团同济堂(贵州)制药有限公司 | 国药准字H52020898 | 0.25g | Category B (乙) | XB02AAA172A001010105535 | NHSA |
| DAIICHI SANKYO CO., LTD. | 国药准字HJ20160282 | 0.5g | Category B (乙) | XB02AAA172A001010179008 | NHSA |
| 浙江赛默制药有限公司 | 国药准字H20263466 | 0.5g | Category B (乙) | XB02AAA172A001010183549 | NHSA |
| 海南药谷云生物科技有限公司 | 国药准字H20256156 | 0.5g | Category B (乙) | XB02AAA172A001010200014 | NHSA |
| 上海信谊万象药业股份有限公司 | 国药准字H31020040 | 0.25g | Category B (乙) | XB02AAA172A001010200804 | NHSA |
| 上海凯宝新谊(新乡)药业有限公司 | 国药准字H41021481 | 0.125g | Category B (乙) | XB02AAA172A001010203085 | NHSA |
| 烟台万润药业有限公司 | 国药准字H20234646 | 0.25g | Category B (乙) | XB02AAA172A001010204223 | NHSA |
| 杭州康恩贝制药有限公司 | 国药准字H20255025 | 0.25g | Category B (乙) | XB02AAA172A001010204489 | NHSA |
| 湖南洞庭药业股份有限公司 | 国药准字H43020564 | 0.25g | Category B (乙) | XB02AAA172A001010204917 | NHSA |
| 浙江赛默制药有限公司 | 国药准字H20263466 | 0.5g | Category B (乙) | XB02AAA172A001010283549 | NHSA |
| 海南药谷云生物科技有限公司 | 国药准字H20256156 | 0.5g | Category B (乙) | XB02AAA172A001010300014 | NHSA |
| 上海信谊万象药业股份有限公司 | 国药准字H31020040 | 0.25g | Category B (乙) | XB02AAA172A001010300804 | NHSA |
| 烟台万润药业有限公司 | 国药准字H20234646 | 0.25g | Category B (乙) | XB02AAA172A001010304223 | NHSA |
| 湖南洞庭药业股份有限公司 | 国药准字H43020564 | 0.25g | Category B (乙) | XB02AAA172A001010304917 | NHSA |
| 浙江赛默制药有限公司 | 国药准字H20263466 | 0.5g | Category B (乙) | XB02AAA172A001010383549 | NHSA |
| 海南药谷云生物科技有限公司 | 国药准字H20256156 | 0.5g | Category B (乙) | XB02AAA172A001010400014 | NHSA |
| 上海信谊万象药业股份有限公司 | 国药准字H31020040 | 0.25g | Category B (乙) | XB02AAA172A001010400804 | NHSA |
| 烟台万润药业有限公司 | 国药准字H20234646 | 0.25g | Category B (乙) | XB02AAA172A001010404223 | NHSA |
| 湖南洞庭药业股份有限公司 | 国药准字H43020564 | 0.25g | Category B (乙) | XB02AAA172A001010404917 | NHSA |
| 浙江赛默制药有限公司 | 国药准字H20263466 | 0.5g | Category B (乙) | XB02AAA172A001010483549 | NHSA |
| 上海信谊万象药业股份有限公司 | 国药准字H31020040 | 0.25g | Category B (乙) | XB02AAA172A001010500804 | NHSA |
| 烟台万润药业有限公司 | 国药准字H20234646 | 0.25g | Category B (乙) | XB02AAA172A001010504223 | NHSA |
| 烟台万润药业有限公司 | 国药准字H20234646 | 0.25g | Category B (乙) | XB02AAA172A001010604223 | NHSA |
| 石家庄四药有限公司 | 国药准字H20263816 | 0.25g | Category B (乙) | XB02AAA172A001020102763 | 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: 11 filings and 8 distinct first applicants.
Generic 11
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏福邦药业有限公司 | CYHS2600960 | Generic | 2026/04/24 | Not stated by source | CDE |
| 常州寅盛药业有限公司 | CYHS2602371 | Generic | 2026/09/21 | Not stated by source | CDE |
| 常州寅盛药业有限公司 | CYHS2602370 | Generic | 2026/09/21 | Not stated by source | CDE |
| 安徽泰恩康制药有限公司 | CYHS2602439 | Generic | 2026/09/30 | Not stated by source | CDE |
| 四川贝灵合益制药有限公司 | CYHS2601889 | Generic | 2026/08/04 | Not stated by source | CDE |
| 重庆科瑞制药（集团）有限公司 | CYHS2601512 | Generic | 2026/06/26 | Not stated by source | CDE |
| 大桐制药（中国）有限责任公司 | CYHS2504106 | Generic | 2025/11/28 | Not stated by source | CDE |
| 广州华圣制药有限公司 | CYHS2503947 | Generic | 2025/11/13 | Not stated by source | CDE |
| 广州华圣制药有限公司 | CYHS2503946 | Generic | 2025/11/13 | Not stated by source | CDE |
| 宁波美诺华天康药业有限公司 | CYHS2502388 | Generic | 2025/07/05 | Not stated by source | CDE |
| 宁波美诺华天康药业有限公司 | CYHS2502387 | Generic | 2025/07/05 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 6 filings and 5 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏福邦药业有限公司 | CYHS2600960 | Generic | 2026/04/24 | Not stated by source | CDE |
| 常州寅盛药业有限公司 | CYHS2602371 | Generic | 2026/09/21 | Not stated by source | CDE |
| 常州寅盛药业有限公司 | CYHS2602370 | Generic | 2026/09/21 | Not stated by source | CDE |
| 安徽泰恩康制药有限公司 | CYHS2602439 | Generic | 2026/09/30 | Not stated by source | CDE |
| 四川贝灵合益制药有限公司 | CYHS2601889 | Generic | 2026/08/04 | Not stated by source | CDE |
| 重庆科瑞制药（集团）有限公司 | CYHS2601512 | Generic | 2026/06/26 | Not stated by source | CDE |
API registrations
Non-component matches: 15 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 |
|---|---|---|---|---|---|---|
| 氨甲环酸 | 江苏天和制药股份有限公司 | Y20260000642 | I | Exact ingredient | 2026/08/03 | CDE |
| 氨甲环酸 | 湖南洞庭药业股份有限公司 | Y20250001276 | I | Exact ingredient | 2025/12/16 | CDE |
| 氨甲环酸 | 浙江竹子制药有限公司 | Y20250000943 | I | Exact ingredient | 2025/09/18 | CDE |
| 氨甲环酸 | 安徽鼎旺医药有限公司 | Y20250000688 | I | Exact ingredient | 2025/07/15 | CDE |
| 氨甲环酸 | 四川仁安药业有限责任公司 | Y20240001282 | A | Exact ingredient | 2026/02/09 | CDE |
| 氨甲环酸 | SHILPA PHARMA LIFESCIENCES LIMITED 100% EOU | Y20230000616 | I | Exact ingredient | 2023/09/12 | CDE |
| 氨甲环酸 | Ami lifesciences Pvt. Ltd. | Y20210000315 | A | Exact ingredient | 2026/09/06 | CDE |
| 氨甲环酸 | 湖南赛隆药业有限公司 | Y20210000177 | A | Exact ingredient | 2026/05/08 | CDE |
| 氨甲环酸 | DAIICHI SANKYO CO.,LTD. | Y20190009106 | A | Exact ingredient | — | CDE |
| 氨甲环酸 | 西安力邦制药有限公司 | Y20190008931 | A | Exact ingredient | 2024/01/31 | CDE |
| 氨甲环酸 | 江苏联环药业股份有限公司 | Y20190006868 | A | Exact ingredient | 2023/03/24 | CDE |
| 氨甲环酸 | 湖北中佳合成制药股份有限公司 | Y20190006325 | A | Exact ingredient | 2026/04/15 | CDE |
| 氨甲环酸 | 常州寅盛药业有限公司 | Y20190006181 | A | Exact ingredient | 2025/12/23 | CDE |
| 氨甲环酸 | 开封制药（集团）有限公司 | Y20190004445 | A | Exact ingredient | 2024/09/11 | CDE |
| 氨甲环酸 | 华润双鹤药业股份有限公司 | Y20190003756 | A | Exact ingredient | — | CDE |
| 氨甲环酸 | 湖南洞庭药业股份有限公司 | Y20190002895 | A | Exact ingredient | 2025/03/04 | CDE |
| 氨甲环酸 | 扬子江药业集团江苏海慈生物药业有限公司 | Y20190002704 | A | Exact ingredient | — | CDE |
| 氨甲环酸 | 海南葫芦娃药业集团股份有限公司 | Y20190002448 | A | Exact ingredient | 2024/07/16 | CDE |
| 氨甲环酸 | 上海现代哈森（商丘）药业有限公司 | Y20190001677 | A | Exact ingredient | 2025/03/12 | CDE |
| 氨甲环酸 | 烟台万润药业有限公司 | Y20170000447 | A | Exact ingredient | 2024/01/12 | 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.
-
2026/09/30Accepted
-
2026/09/21Accepted
-
2026/09/21Accepted
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 Tranexamic Acid 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