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Nafamostat Mesilate for Injection

As of 13 November 2026, for Nafamostat Mesilate for Injection, 38 applications are listed as under review at China's CDE; 24 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 1 holder.

Companies, stages and changes, with each record available on this page.

Last 90 days: Accepted: 3 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

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: 1 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 1 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Jiangsu Du Rui Pharmaceutical Co., Ltd. romanizedJiangsu Du Rui Pharmaceutical Co., Ltd. romanized国药准字H202035082020/09/3010mgGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Du Rui Pharmaceutical Co., Ltd. romanizedJiangsu Du Rui Pharmaceutical Co., Ltd. romanized国药准字H202035092020/09/3050mgGeneric approved under the new chemical-drug registration classificationCDE

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: 2 distinct approval numbers and 1 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Jiangsu Du Rui Pharmaceutical Co., Ltd. romanized国药准字H2020350810mgCategory BXB01AXN121B001010110101NHSA
Jiangsu Du Rui Pharmaceutical Co., Ltd. romanized国药准字H2020350950mgCategory BXB01AXN121B001010210101NHSA
Jiangsu Du Rui Pharmaceutical Co., Ltd. romanized国药准字H2020350950mgCategory BXB01AXN121B001010310101NHSA
Jiangsu Du Rui Pharmaceutical Co., Ltd. romanized国药准字H2020350810mgCategory BXB01AXN121B001020110101NHSA

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: 38 filings and 24 distinct first applicants.

Generic 38

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Haikou Shi Pharmaceutical Factory Co., Ltd. romanizedCYHS2602407Generic2026/09/24Not stated by sourceCDE
Haikou Shi Pharmaceutical Factory Co., Ltd. romanizedCYHS2602406Generic2026/09/24Not stated by sourceCDE
Wuhan Hua Long Biopharmaceutical Co., Ltd. romanizedCYHS2602272Generic2026/09/11Not stated by sourceCDE
Henan Xin Tai Pharma Co., Ltd. romanizedCYHS2601885Generic2026/08/04Not stated by sourceCDE
Henan Xin Tai Pharma Co., Ltd. romanizedCYHS2601884Generic2026/08/04Not stated by sourceCDE
Chengdu Sai Nuo Lian Chuang Bio Technology Co., Ltd. romanized; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanizedCYHS2601838Generic2026/07/30Not stated by sourceCDE
Name not romanized; Jiangsu Li Tai Er Pharma Co., Ltd. romanizedCYHS2601772Generic2026/07/23Not stated by sourceCDE
Fujian Da Pu Biopharmaceuticals Co., Ltd. romanized; Wuhan Hai Te Biopharmaceutical Co., Ltd. romanizedCYHS2601711Generic2026/07/17Not stated by sourceCDE
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanizedCYHS2601594Generic2026/07/06Not stated by sourceCDE
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanizedCYHS2601593Generic2026/07/06Not stated by sourceCDE
Chengdu Yao Yi Li Kang Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanizedCYHS2601592Generic2026/07/06Not stated by sourceCDE
Tianjin Hong Ri Pharma Co., Ltd. romanized; Wuhan Ren Fu Pharma Co., Ltd. romanizedCYHS2601589Generic2026/07/06Not stated by sourceCDE
Kang Pu Pharma Co., Ltd. romanizedCYHS2601580Generic2026/07/03Not stated by sourceCDE
Kang Pu Pharma Co., Ltd. romanizedCYHS2601579Generic2026/07/03Not stated by sourceCDE
Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCYHS2601519Generic2026/06/29Not stated by sourceCDE
Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCYHS2601518Generic2026/06/29Not stated by sourceCDE
Guangdong Jian Xin Pharmaceutical Co., Ltd. romanizedCYHS2601505Generic2026/06/26Not stated by sourceCDE
Guangdong Jian Xin Pharmaceutical Co., Ltd. romanizedCYHS2601504Generic2026/06/26Not stated by sourceCDE
Chongqing Lai Mei Pharma Co., Ltd. romanizedCYHS2601499Generic2026/06/25Not stated by sourceCDE
Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Zhejiang Ya Tai Pharma Co., Ltd. romanizedCYHS2601495Generic2026/06/25Not stated by sourceCDE
Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Zhejiang Ya Tai Pharma Co., Ltd. romanizedCYHS2601494Generic2026/06/25Not stated by sourceCDE
Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanizedCYHS2601470Generic2026/06/23Not stated by sourceCDE
Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanizedCYHS2601469Generic2026/06/23Not stated by sourceCDE
Beijing Sai Sheng Pharma Co., Ltd. romanizedCYHS2601465Generic2026/06/23Not stated by sourceCDE
Beijing Sai Sheng Pharma Co., Ltd. romanizedCYHS2601464Generic2026/06/23Not stated by sourceCDE
Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jilin Jin Sheng Pharmaceutical Co., Ltd. romanizedCYHS2601456Generic2026/06/18Not stated by sourceCDE
Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jilin Jin Sheng Pharmaceutical Co., Ltd. romanizedCYHS2601455Generic2026/06/18Not stated by sourceCDE
Hunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Sai Long Pharma (Changsha) Co., Ltd. romanizedCYHS2601443Generic2026/06/17Not stated by sourceCDE
Hunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Sai Long Pharma (Changsha) Co., Ltd. romanizedCYHS2601442Generic2026/06/17Not stated by sourceCDE
Chengdu Easton Biopharmaceuticals Co.,Ltd.; Chengdu Tong De Pharma Co., Ltd. romanizedCYHS2601408Generic2026/06/15Not stated by sourceCDE
Chongqing Huapont Pharmaceutical Co., Ltd.CYHS2601406Generic2026/06/12Not stated by sourceCDE
Chongqing Huapont Pharmaceutical Co., Ltd.CYHS2601405Generic2026/06/12Not stated by sourceCDE
Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.CYHS2601358Generic2026/06/10Not stated by sourceCDE
Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.CYHS2601357Generic2026/06/10Not stated by sourceCDE
Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized; Hunan Sai Long Pharma (Changsha) Co., Ltd. romanizedCYHS2601327Generic2026/06/08Not stated by sourceCDE
Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanizedCYHS2601294Generic2026/06/04Not stated by sourceCDE
Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCYHS2601042Generic2026/05/08Not stated by sourceCDE
Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCYHS2601040Generic2026/05/08Not stated by sourceCDE
New generic filings in 2026

Loaded records: 41 filings and 24 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Haikou Shi Pharmaceutical Factory Co., Ltd. romanizedCYHS2602407Generic2026/09/24Not stated by sourceCDE
Haikou Shi Pharmaceutical Factory Co., Ltd. romanizedCYHS2602406Generic2026/09/24Not stated by sourceCDE
Wuhan Hua Long Biopharmaceutical Co., Ltd. romanizedCYHS2602272Generic2026/09/11Not stated by sourceCDE
Henan Xin Tai Pharma Co., Ltd. romanizedCYHS2601885Generic2026/08/04Not stated by sourceCDE
Henan Xin Tai Pharma Co., Ltd. romanizedCYHS2601884Generic2026/08/04Not stated by sourceCDE
Chengdu Sai Nuo Lian Chuang Bio Technology Co., Ltd. romanized; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanizedCYHS2601838Generic2026/07/30Not stated by sourceCDE
Name not romanized; Jiangsu Li Tai Er Pharma Co., Ltd. romanizedCYHS2601772Generic2026/07/23Not stated by sourceCDE
Fujian Da Pu Biopharmaceuticals Co., Ltd. romanized; Wuhan Hai Te Biopharmaceutical Co., Ltd. romanizedCYHS2601711Generic2026/07/17Not stated by sourceCDE
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanizedCYHS2601594Generic2026/07/06Not stated by sourceCDE
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanizedCYHS2601593Generic2026/07/06Not stated by sourceCDE
Chengdu Yao Yi Li Kang Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanizedCYHS2601592Generic2026/07/06Not stated by sourceCDE
Tianjin Hong Ri Pharma Co., Ltd. romanized; Wuhan Ren Fu Pharma Co., Ltd. romanizedCYHS2601589Generic2026/07/06Not stated by sourceCDE
Kang Pu Pharma Co., Ltd. romanizedCYHS2601580Generic2026/07/03Not stated by sourceCDE
Kang Pu Pharma Co., Ltd. romanizedCYHS2601579Generic2026/07/03Not stated by sourceCDE
Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCYHS2601519Generic2026/06/29Not stated by sourceCDE
Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCYHS2601518Generic2026/06/29Not stated by sourceCDE
Guangdong Jian Xin Pharmaceutical Co., Ltd. romanizedCYHS2601505Generic2026/06/26Not stated by sourceCDE
Guangdong Jian Xin Pharmaceutical Co., Ltd. romanizedCYHS2601504Generic2026/06/26Not stated by sourceCDE
Chongqing Lai Mei Pharma Co., Ltd. romanizedCYHS2601499Generic2026/06/25Not stated by sourceCDE
Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Zhejiang Ya Tai Pharma Co., Ltd. romanizedCYHS2601495Generic2026/06/25Not stated by sourceCDE
Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Zhejiang Ya Tai Pharma Co., Ltd. romanizedCYHS2601494Generic2026/06/25Not stated by sourceCDE
Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanizedCYHS2601470Generic2026/06/23Not stated by sourceCDE
Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanizedCYHS2601469Generic2026/06/23Not stated by sourceCDE
Beijing Sai Sheng Pharma Co., Ltd. romanizedCYHS2601465Generic2026/06/23Not stated by sourceCDE
Beijing Sai Sheng Pharma Co., Ltd. romanizedCYHS2601464Generic2026/06/23Not stated by sourceCDE
Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jilin Jin Sheng Pharmaceutical Co., Ltd. romanizedCYHS2601456Generic2026/06/18Not stated by sourceCDE
Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jilin Jin Sheng Pharmaceutical Co., Ltd. romanizedCYHS2601455Generic2026/06/18Not stated by sourceCDE
Hunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Sai Long Pharma (Changsha) Co., Ltd. romanizedCYHS2601443Generic2026/06/17Not stated by sourceCDE
Hunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Sai Long Pharma (Changsha) Co., Ltd. romanizedCYHS2601442Generic2026/06/17Not stated by sourceCDE
Chengdu Easton Biopharmaceuticals Co.,Ltd.; Chengdu Tong De Pharma Co., Ltd. romanizedCYHS2601408Generic2026/06/15Not stated by sourceCDE
Chongqing Huapont Pharmaceutical Co., Ltd.CYHS2601406Generic2026/06/12Not stated by sourceCDE
Chongqing Huapont Pharmaceutical Co., Ltd.CYHS2601405Generic2026/06/12Not stated by sourceCDE
Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.CYHS2601358Generic2026/06/10Not stated by sourceCDE
Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.CYHS2601357Generic2026/06/10Not stated by sourceCDE
Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized; Hunan Sai Long Pharma (Changsha) Co., Ltd. romanizedCYHS2601327Generic2026/06/08Not stated by sourceCDE
Yan Tai Dong Cheng Bei Fang Pharmaceutical Co., Ltd. romanizedCYHS2601294Generic2026/06/04Not stated by sourceCDE
Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCYHS2601042Generic2026/05/08Not stated by sourceCDE
Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCYHS2601040Generic2026/05/08Not stated by sourceCDE
Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanizedCYHL2600028Generic2026/02/25Not stated by sourceCDE
Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanizedCYHL2600027Generic2026/02/25Not stated by sourceCDE
Name not romanizedCYHL2600023Generic2026/02/11Not stated by sourceCDE
API registrations

Non-component matches: 9 companies with A status and 8 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
甲磺酸萘莫司他 · No verified English nameFu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanizedY20260000351IExact ingredient2026/04/30CDE
甲磺酸萘莫司他 · No verified English nameHenan Jing Kang Pharmaceutical Co., Ltd. romanizedY20260000256IExact ingredient2026/04/08CDE
甲磺酸萘莫司他 · No verified English nameAnhui Yue Kang Kai Yue Pharmaceutical Co., Ltd. romanizedY20250001142IExact ingredient2025/11/28CDE
甲磺酸萘莫司他 · No verified English nameFujian Nan Fang Pharmaceutical Co., Ltd. romanizedY20250000687IExact ingredient2025/07/21CDE
甲磺酸萘莫司他 · No verified English nameNei Menggu Jing Dong Pharma Co., Ltd. romanizedY20250000677IExact ingredient2025/07/10CDE
甲磺酸萘莫司他 · No verified English nameXuan Cheng Mei Nuo Hua Pharma Co., Ltd. romanizedY20250000463IExact ingredient2025/07/08CDE
甲磺酸萘莫司他 · No verified English nameHebei Guang Xiang Pharmaceutical Co., Ltd. romanizedY20250000314IExact ingredient2025/04/10CDE
甲磺酸萘莫司他 · No verified English nameChongqing Sheng Kai Pharmaceutical Co., Ltd. romanizedY20250000318AExact ingredient2026/09/16CDE
甲磺酸萘莫司他 · No verified English nameSichuan Qing Mu Pharmaceutical Co., Ltd. romanizedY20240001465AExact ingredient2026/03/30CDE
甲磺酸萘莫司他 · No verified English nameZhong Rui (Nei Menggu) Pharma Co., Ltd. romanizedY20240001325IExact ingredient2026/03/12CDE
甲磺酸萘莫司他 · No verified English nameHunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanizedY20240000826AExact ingredient2026/06/02CDE
甲磺酸萘莫司他 · No verified English nameSichuan Kelun Pharmaceutical Co., Ltd.Y20240000248AExact ingredient2025/09/30CDE
甲磺酸萘莫司他 · No verified English nameKang Pu Pharma Co., Ltd. romanizedY20230001395AExact ingredient2025/10/01CDE
甲磺酸萘莫司他 · No verified English nameLanzhou Bo Cheng Kang Yuan Pharma Co., Ltd. romanizedY20230001207AExact ingredient2026/08/07CDE
甲磺酸萘莫司他 · No verified English nameAurore Pharmaceuticals Private LimitedY20230000142AExact ingredient2026/06/09CDE
甲磺酸萘莫司他 · No verified English nameShandong Lang Nuo Pharmaceutical Co., Ltd. romanizedY20200001018AExact ingredient2024/06/28CDE
甲磺酸萘莫司他 · No verified English nameJiangsu Du Rui Pharmaceutical Co., Ltd. romanizedY20170001582AExact ingredient2025/07/12CDE

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.

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. 2026/09/24Accepted

    Haikou Shi Pharmaceutical Factory Co., Ltd. romanized

    CYHS2602407

    Fact date: 2026/09/24 · Site observation date: 2026/10/21

    View source ↗
  2. 2026/09/24Accepted

    Haikou Shi Pharmaceutical Factory Co., Ltd. romanized

    CYHS2602406

    Fact date: 2026/09/24 · Site observation date: 2026/10/21

    View source ↗
  3. 2026/09/11Accepted

    Wuhan Hua Long Biopharmaceutical Co., Ltd. romanized

    CYHS2602272

    Fact date: 2026/09/11 · 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.

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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