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Company directoryChina company filings

Fujian Dong Rui Pharmaceutical Co., Ltd. romanized

Check drug filings and source records for this company-name string.

Listed by the company name as recorded in the source, without merging affiliated entities.

Page reference b6e9184e1e

Complete CDE snapshot
2026/11/13 06:42
Matching scope
Loaded public-source records only

These counts cover loaded acceptance records only. First-applicant and co-applicant counts are not added together. CDE data as of 2026/11/13 06:42.

Drug filings

13 acceptance records as first applicant, grouped into 9 source drug names. Source data as of 2026/11/13 06:42.

Acceptance records are de-duplicated by acceptance number. Drug names are normalized only for width and whitespace; dosage forms and combinations remain separate. Application types are retained from the source. Expand a drug to inspect each record. Published drugs link to their drug pages; other names do not create new public drug pages.

Mirogabalin Besilate Tablets 2 records · Latest accepted 2026/10/14

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2602540Generic2026/10/14Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2602539Generic2026/10/14Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
Trazodone Hydrochloride Tablets 2 records · Latest accepted 2026/04/14

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2600745Supplement2026/04/14Fujian Dong Rui Pharmaceutical Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanizedCDE ↗
CYHB2600744Supplement2026/04/14Fujian Dong Rui Pharmaceutical Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanizedCDE ↗
Finerenone Tablets 1 records · Latest accepted 2026/04/11

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2600843Generic2026/04/11Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
Metformin Hydrochloride Extended-Release Tablets 1 records · Latest accepted 2026/03/26

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2600598Supplement2026/03/26Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
Rosuvastatin Calcium and Ezetimibe Tablets (I) 1 records · Latest accepted 2025/11/24

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2504042Generic2025/11/24Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
Azilsartan Medoxomil Potassium Tablets 2 records · Latest accepted 2025/08/13

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2502949Generic2025/08/13Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2502948Generic2025/08/13Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
Benidipine Hydrochloride Tablets 2 records · Latest accepted 2025/03/21

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501134Generic2025/03/21Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2501133Generic2025/03/21Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
Loxoprofen Sodium Tablets 1 records · Latest accepted 2023/03/24

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2350288Supplement2023/03/24Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
Valsartan and Amlodipine Tablets(I) 1 records · Latest accepted 2021/11/10

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2102001Generic2021/11/10Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCDE ↗

Changes in the last 90 days

3 events from 2026/08/16 to 2026/11/13. CDE data as of 2026/11/13 06:42; NMPA data as of 2026/11/12 18:32.

This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.

Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately. 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.

Accepted: 2 applicationsNotification delivery: 1 application

  1. 2026/10/28Notification delivery

    Rosuvastatin Calcium and Ezetimibe Tablets (I)

    CYHS2504042

    Fact date: 2026/10/28 (Publication date) · Publication date: 2026/10/28 · Site observation date: 2026/11/03

    Notification delivered; the specific outcome remains to be checked.

    View source · Table row 16 ↗
  2. 2026/10/14Accepted

    Mirogabalin Besilate Tablets

    CYHS2602540

    Fact date: 2026/10/14 · Site observation date: 2026/10/22

    View source ↗
  3. 2026/10/14Accepted

    Mirogabalin Besilate Tablets

    CYHS2602539

    Fact date: 2026/10/14 · Site observation date: 2026/10/22

    View source ↗

Under review

6 acceptance numbers with this company as first applicant are currently listed as under review by CDE. Source data as of 2026/11/13 06:42.

Under review
Drug Acceptance numberApplication typeAcceptedCompany / applicantView source
Mirogabalin Besilate Tablets CYHS2602540Generic2026/10/14Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
Mirogabalin Besilate Tablets CYHS2602539Generic2026/10/14Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
Finerenone Tablets CYHS2600843Generic2026/04/11Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
Metformin Hydrochloride Extended-Release Tablets CYHB2600598Supplement2026/03/26Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
Azilsartan Medoxomil Potassium Tablets CYHS2502949Generic2025/08/13Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
Azilsartan Medoxomil Potassium Tablets CYHS2502948Generic2025/08/13Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCDE ↗

Catalogue holder records

8 loaded active catalogue records whose holder name matches this source company name. Source data as of 2026/11/13 06:39. Manufacturer-only records are excluded.

DrugMarketing authorization holderManufacturerApproval numberApprovedCatalogue category (source text)View source
Benidipine Hydrochloride TabletsFujian Dong Rui Pharmaceutical Co., Ltd. romanizedFujian Dong Rui Pharmaceutical Co., Ltd. romanized国药准字H202659402026/09/15Generic approved under the new chemical-drug registration classificationCDE ↗
Benidipine Hydrochloride TabletsFujian Dong Rui Pharmaceutical Co., Ltd. romanizedFujian Dong Rui Pharmaceutical Co., Ltd. romanized国药准字H202659412026/09/15Generic approved under the new chemical-drug registration classificationCDE ↗
Trazodone Hydrochloride TabletsFujian Dong Rui Pharmaceutical Co., Ltd. romanizedShenzhen Xin Li Tai Pharma Co., Ltd. romanized国药准字H202645712026/05/27Generic approved under the new chemical-drug registration classificationCDE ↗
Trazodone Hydrochloride TabletsFujian Dong Rui Pharmaceutical Co., Ltd. romanizedShenzhen Xin Li Tai Pharma Co., Ltd. romanized国药准字H202645722026/05/27Generic approved under the new chemical-drug registration classificationCDE ↗
Loxoprofen Sodium TabletsFujian Dong Rui Pharmaceutical Co., Ltd. romanizedFujian Dong Rui Pharmaceutical Co., Ltd. romanized国药准字H200411432024/02/02Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Valsartan and Amlodipine Tablets(I)Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedFujian Dong Rui Pharmaceutical Co., Ltd. romanized国药准字H202339552023/07/25Generic approved under the new chemical-drug registration classificationCDE ↗
Metformin Hydrochloride Extended-Release TabletsFujian Dong Rui Pharmaceutical Co., Ltd. romanizedFujian Dong Rui Pharmaceutical Co., Ltd. romanized国药准字H202233802022/06/16Generic approved under the new chemical-drug registration classificationCDE ↗
Rosuvastatin Calcium TabletsFujian Dong Rui Pharmaceutical Co., Ltd. romanizedFujian Dong Rui Pharmaceutical Co., Ltd. romanized国药准字H202130062021/01/05Generic approved under the new chemical-drug registration classificationCDE ↗

Only active catalogue records matching the source holder name are listed. A manufacturer role does not count as a holder record. The catalogue covers only part of the chemical-drug market; source categories do not establish complete market coverage or qualifications.

API registrations

0 loaded active API registrations whose first registered company matches this source company name. Source data as of 2026/11/13 06:41.

NameCompany / applicantRegistration numberStatusSource update dateView source
No matching records were found in the currently loaded source data; coverage dates are listed below.

Only loaded active API registrations not listed as cancelled are shown. A/I are source registration statuses. Records are listed by registration number and do not establish capacity or supply. The register does not identify the associated formulation.

Co-applicant records

2 acceptance records name this company after the first applicant. They are listed separately and are not included in first-applicant drug or filing counts. Source data as of 2026/11/13 06:42.

Co-applicant records
Drug Acceptance numberApplication typeAcceptedCompany / applicantView source
菠萝蛋白酶肠溶片 · No verified English name CYHB2302286Supplement2023/10/13Nanjing Hai Jing Pharma Co., Ltd. romanized; Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
菠萝蛋白酶肠溶片 · No verified English name CYHB2302285Supplement2023/10/13Nanjing Hai Jing Pharma Co., Ltd. romanized; Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCDE ↗

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
Full API register
Last successful update: 2026/11/13 06:41
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.

Listed by the company name as recorded in the source, without merging affiliated entities.

This page summarizes loaded records only, without new source queries or collection. Parent companies, subsidiaries, former names and aliases are not merged. Counts from different sources must not be added together. No loaded record does not establish the absence of a filing or registration. Check original records where coverage is incomplete, an update has failed, or a source lies outside the loaded scope.

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.

Drugs with a verified official English name use that name only. Other drug names retain the Chinese source name marked No verified English name; names with a Chinese public page link to that page. Company labels use verified official names, Latin source names, then fixed-rule transliterations marked romanized; Chinese company names are not displayed. Marked unverified drug names and original statutory reference numbers may appear in Chinese.

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.