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Tranexamic Acid Tablets

As of 13 November 2026, for Tranexamic Acid Tablets, 9 applications are listed as under review at China's CDE; 5 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.

Listed in the US FDA Orange Book as LYSTEDA (NDA 022430, J MOLNER HOLDINGS INC).

Last 90 days: Accepted: 3 applicationsNo longer listed under review: 2 applications

Current coverage may be incomplete

Follow for free
Complete CDE snapshot
2026/11/13 06:42
Matching scope
Same generic name; dosage forms and combinations kept separate

US Orange Book listing

The brand names come from the US FDA Orange Book and describe US listing records for this active ingredient. They do not indicate that products under these brand names are approved or sold in China, or that Chinese applicants are affiliated with US holders.

Orange Book source export date: 2026/11/06. Version: 2026-11-06.

Showing 2 of 2 distinct brand names.

A brand with different source forms or statuses can appear on multiple rows and in both groups. Distinct brand names are counted once globally, with a limit of five.

Verified official English dosage form: Tablets. Listings are grouped by the source dosage form and route; records without a clear correspondence are listed in the other group. Grouping does not establish product equivalence.

Same dosage form

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
LYSTEDA J MOLNER HOLDINGS INC NDA 022430 · Product no. 001 TABLET ORAL HUMAN PRESCRIPTION DRUG 2009/11/13
CYKLOKAPRON PHARMACIA AND UPJOHN CO NDA 019280 · Product no. 001 TABLET ORAL DISCONTINUED 1986/12/30

Other dosage forms of the same ingredient

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
CYKLOKAPRON PFIZER INC NDA 019281 · Product no. 001 INJECTABLE INJECTION HUMAN PRESCRIPTION DRUG 1986/12/30

Same-form/route listings come first, followed by other forms/routes. Within each group, source prescription/OTC listings precede discontinued listings; unknown statuses are last. Each status bucket is ordered by earliest approval date, ascending: pre-1982 records first, missing dates last; ties by brand name, application number and product number. The first five distinct brands in this order are selected globally. All retained source facts for those brands are shown in their own groups; a brand spanning both groups counts once.

Ingredient cross-list details ↗

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.

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 holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Chengdu Brilliant Pharmaceutical Co., Ltd.Chengdu Brilliant Pharmaceutical Co., Ltd.国药准字H202642992026/05/120.25gGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Xiong Di Pharma Co., Ltd. romanizedHuayi Pharmaceuticals (Anhui) Co., Ltd.国药准字H202640552026/04/210.5gGeneric approved under the new chemical-drug registration classificationCDE
Shijiazhuang No.4 Pharmaceutical Co., Ltd.Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202638162026/03/310.25gGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanizedZhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H202634662026/02/250.5gGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Ziyond Pharmaceutical Co., Ltd.Jiangsu Ziyond Pharmaceutical Co., Ltd.国药准字H202631082026/01/140.25gGeneric approved under the new chemical-drug registration classificationCDE
Hainan Yao Gu Yun Bio Technology Co., Ltd. romanizedBeijing Bei Lu Pharma Co., Ltd. romanized国药准字H202561562025/12/030.5gGeneric approved under the new chemical-drug registration classificationCDE
Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanizedHangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized国药准字H202550252025/07/290.25gGeneric approved under the new chemical-drug registration classificationCDE
Yan Tai Wan Run Pharma Co., Ltd. romanizedYan Tai Wan Run Pharma Co., Ltd. romanized国药准字H202346462023/12/130.25gGeneric approved under the new chemical-drug registration classificationCDE
Hunan Dong Ting Pharma Co., Ltd. romanizedHunan Dong Ting Pharma Co., Ltd. romanized国药准字H430205642023/10/300.25gDrug that passed quality-and-efficacy consistency evaluationCDE
Di Yi San Gong Zhu Shi Hui She romanizedCMIC CMO CO.,LTD.Shizuoka PlantH201602822000/10/070.5gImported originator drugCDE

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 / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized国药准字H202561560.5gCategory BXB02AAA172A001010100014NHSA
Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized国药准字H310200400.25gCategory BXB02AAA172A001010100804NHSA
Chengdu Brilliant Pharmaceutical Co., Ltd.国药准字H202642990.25gCategory BXB02AAA172A001010102013NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202534130.5gCategory BXB02AAA172A001010102763NHSA
Shanghai Kai Bao Xin Yi (Xin Xiang) Pharma Co., Ltd. romanized国药准字H410214810.125gCategory BXB02AAA172A001010103085NHSA
Jilin Wan Tong Pharma Group Zhengzhou Wan Tong Fu Sheng Pharma Co., Ltd. romanized国药准字H410256280.125gCategory BXB02AAA172A001010103250NHSA
Yan Tai Wan Run Pharma Co., Ltd. romanized国药准字H202346460.25gCategory BXB02AAA172A001010104223NHSA
Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized国药准字H202550250.25gCategory BXB02AAA172A001010104489NHSA
Hunan Dong Ting Pharma Co., Ltd. romanized国药准字H430205640.25gCategory BXB02AAA172A001010104917NHSA
Guo Yao Group Tong Ji Tang (Guizhou) Pharmaceutical Co., Ltd. romanized国药准字H520208980.25gCategory BXB02AAA172A001010105535NHSA
DAIICHI SANKYO CO., LTD.国药准字HJ201602820.5gCategory BXB02AAA172A001010179008NHSA
Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H202634660.5gCategory BXB02AAA172A001010183549NHSA
Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized国药准字H202561560.5gCategory BXB02AAA172A001010200014NHSA
Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized国药准字H310200400.25gCategory BXB02AAA172A001010200804NHSA
Shanghai Kai Bao Xin Yi (Xin Xiang) Pharma Co., Ltd. romanized国药准字H410214810.125gCategory BXB02AAA172A001010203085NHSA
Yan Tai Wan Run Pharma Co., Ltd. romanized国药准字H202346460.25gCategory BXB02AAA172A001010204223NHSA
Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized国药准字H202550250.25gCategory BXB02AAA172A001010204489NHSA
Hunan Dong Ting Pharma Co., Ltd. romanized国药准字H430205640.25gCategory BXB02AAA172A001010204917NHSA
Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H202634660.5gCategory BXB02AAA172A001010283549NHSA
Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized国药准字H202561560.5gCategory BXB02AAA172A001010300014NHSA
Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized国药准字H310200400.25gCategory BXB02AAA172A001010300804NHSA
Yan Tai Wan Run Pharma Co., Ltd. romanized国药准字H202346460.25gCategory BXB02AAA172A001010304223NHSA
Hunan Dong Ting Pharma Co., Ltd. romanized国药准字H430205640.25gCategory BXB02AAA172A001010304917NHSA
Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H202634660.5gCategory BXB02AAA172A001010383549NHSA
Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized国药准字H202561560.5gCategory BXB02AAA172A001010400014NHSA
Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized国药准字H310200400.25gCategory BXB02AAA172A001010400804NHSA
Yan Tai Wan Run Pharma Co., Ltd. romanized国药准字H202346460.25gCategory BXB02AAA172A001010404223NHSA
Hunan Dong Ting Pharma Co., Ltd. romanized国药准字H430205640.25gCategory BXB02AAA172A001010404917NHSA
Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H202634660.5gCategory BXB02AAA172A001010483549NHSA
Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized国药准字H310200400.25gCategory BXB02AAA172A001010500804NHSA
Yan Tai Wan Run Pharma Co., Ltd. romanized国药准字H202346460.25gCategory BXB02AAA172A001010504223NHSA
Yan Tai Wan Run Pharma Co., Ltd. romanized国药准字H202346460.25gCategory BXB02AAA172A001010604223NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202638160.25gCategory BXB02AAA172A001020102763NHSA

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: 9 filings and 7 distinct first applicants.

Generic 9

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jiangsu Fu Bang Pharma Co., Ltd. romanizedCYHS2600960Generic2026/04/24Not stated by sourceCDE
Changzhou Yin Sheng Pharma Co., Ltd. romanizedCYHS2602371Generic2026/09/21Not stated by sourceCDE
Changzhou Yin Sheng Pharma Co., Ltd. romanizedCYHS2602370Generic2026/09/21Not stated by sourceCDE
Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCYHS2602439Generic2026/09/30Not stated by sourceCDE
Sichuan Bei Ling He Yi Pharmaceutical Co., Ltd. romanizedCYHS2601889Generic2026/08/04Not stated by sourceCDE
Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanizedCYHS2601512Generic2026/06/26Not stated by sourceCDE
Da Tong Pharmaceutical (Zhongguo) Co., Ltd. romanizedCYHS2504106Generic2025/11/28Not stated by sourceCDE
Guangzhou Hua Sheng Pharmaceutical Co., Ltd. romanizedCYHS2503947Generic2025/11/13Not stated by sourceCDE
Guangzhou Hua Sheng Pharmaceutical Co., Ltd. romanizedCYHS2503946Generic2025/11/13Not stated by sourceCDE
New generic filings in 2026

Loaded records: 6 filings and 5 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jiangsu Fu Bang Pharma Co., Ltd. romanizedCYHS2600960Generic2026/04/24Not stated by sourceCDE
Changzhou Yin Sheng Pharma Co., Ltd. romanizedCYHS2602371Generic2026/09/21Not stated by sourceCDE
Changzhou Yin Sheng Pharma Co., Ltd. romanizedCYHS2602370Generic2026/09/21Not stated by sourceCDE
Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCYHS2602439Generic2026/09/30Not stated by sourceCDE
Sichuan Bei Ling He Yi Pharmaceutical Co., Ltd. romanizedCYHS2601889Generic2026/08/04Not stated by sourceCDE
Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanizedCYHS2601512Generic2026/06/26Not stated by sourceCDE
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.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
氨甲环酸 · No verified English nameJiangsu Tian He Pharmaceutical Co., Ltd. romanizedY20260000642IExact ingredient2026/08/03CDE
氨甲环酸 · No verified English nameHunan Dong Ting Pharma Co., Ltd. romanizedY20250001276IExact ingredient2025/12/16CDE
氨甲环酸 · No verified English nameZhejiang Zhu Zi Pharmaceutical Co., Ltd. romanizedY20250000943IExact ingredient2025/09/18CDE
氨甲环酸 · No verified English nameAnhui Ding Wang Pharmaceuticals Co., Ltd. romanizedY20250000688IExact ingredient2025/07/15CDE
氨甲环酸 · No verified English nameSichuan Ren An Pharma Co., Ltd. romanizedY20240001282AExact ingredient2026/02/09CDE
氨甲环酸 · No verified English nameSHILPA PHARMA LIFESCIENCES LIMITED 100% EOUY20230000616IExact ingredient2023/09/12CDE
氨甲环酸 · No verified English nameAmi lifesciences Pvt. Ltd.Y20210000315AExact ingredient2026/09/06CDE
氨甲环酸 · No verified English nameHunan Sai Long Pharma Co., Ltd. romanizedY20210000177AExact ingredient2026/05/08CDE
氨甲环酸 · No verified English nameDAIICHI SANKYO CO.,LTD.Y20190009106AExact ingredient—CDE
氨甲环酸 · No verified English nameXian Li Bang Pharmaceutical Co., Ltd. romanizedY20190008931AExact ingredient2024/01/31CDE
氨甲环酸 · No verified English nameJiangsu Lianhuan Pharmaceutical Co.,Ltd.Y20190006868AExact ingredient2023/03/24CDE
氨甲环酸 · No verified English nameHubei Zhong Jia He Cheng Pharmaceutical Co., Ltd. romanizedY20190006325AExact ingredient2026/04/15CDE
氨甲环酸 · No verified English nameChangzhou Yin Sheng Pharma Co., Ltd. romanizedY20190006181AExact ingredient2025/12/23CDE
氨甲环酸 · No verified English nameKai Feng Pharmaceutical (Group) Co., Ltd. romanizedY20190004445AExact ingredient2024/09/11CDE
氨甲环酸 · No verified English nameHua Run Shuang He Pharma Co., Ltd. romanizedY20190003756AExact ingredient—CDE
氨甲环酸 · No verified English nameHunan Dong Ting Pharma Co., Ltd. romanizedY20190002895AExact ingredient2025/03/04CDE
氨甲环酸 · No verified English nameYang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanizedY20190002704AExact ingredient—CDE
氨甲环酸 · No verified English nameHainan Huluwa Pharmaceutical Group Co., Ltd.Y20190002448AExact ingredient2024/07/16CDE
氨甲环酸 · No verified English nameShanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanizedY20190001677AExact ingredient2025/03/12CDE
氨甲环酸 · No verified English nameYan Tai Wan Run Pharma Co., Ltd. romanizedY20170000447AExact ingredient2024/01/12CDE

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.

  1. 2026/11/13No longer listed under review

    Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.

    CYHS2502388

    Fact date: 2026/11/13 · Site observation date: 2026/11/13

    Accepted: 2025/07/05

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  2. 2026/11/13No longer listed under review

    Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.

    CYHS2502387

    Fact date: 2026/11/13 · Site observation date: 2026/11/13

    Accepted: 2025/07/05

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  3. 2026/09/30Accepted

    Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized

    CYHS2602439

    Fact date: 2026/09/30 · Site observation date: 2026/10/22

    View source ↗
  4. 2026/09/21Accepted

    Changzhou Yin Sheng Pharma Co., Ltd. romanized

    CYHS2602371

    Fact date: 2026/09/21 · Site observation date: 2026/10/21

    View source ↗
  5. 2026/09/21Accepted

    Changzhou Yin Sheng Pharma Co., Ltd. romanized

    CYHS2602370

    Fact date: 2026/09/21 · Site observation date: 2026/10/21

    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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