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Company directoryChina company filings

Shanghai Fu Dan Fu Hua Pharma 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 7324b65fd3

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

11 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 1 records · Latest accepted 2026/11/05

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2602710Generic2026/11/05Shanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedCDE ↗
氟他胺片 · No verified English name 1 records · Latest accepted 2025/11/07

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2502304Supplement2025/11/07Shanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedCDE ↗
Brexpiprazole Tablets 3 records · Latest accepted 2025/06/11

Generic · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2502059Generic2025/06/11Shanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedCDE ↗
CYHS2502058Generic2025/06/11Shanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedCDE ↗
CYHS2502057Generic2025/06/11Shanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedCDE ↗
根痛平片 · No verified English name 1 records · Latest accepted 2025/03/12

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYZB2500428Supplement2025/03/12Shanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedCDE ↗
当归补血胶囊 · No verified English name 1 records · Latest accepted 2025/03/10

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYZB2500415Supplement2025/03/10Shanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedCDE ↗
Tamoxifen Citrate Tablets 1 records · Latest accepted 2024/07/16

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2450378Supplement2024/07/16Shanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedCDE ↗
Carbamazepine Tablets 1 records · Latest accepted 2024/01/04

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2400027Supplement2024/01/04Shanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedCDE ↗
比卡鲁胺片 · No verified English name 1 records · Latest accepted 2021/03/26

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2150178Supplement2021/03/26Shanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedCDE ↗
盐酸赛庚啶片 · No verified English name 1 records · Latest accepted 2021/03/10

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2150157Supplement2021/03/10Shanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedCDE ↗

Changes in the last 90 days

4 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: 1 applicationNo longer listed under review: 3 applications

  1. 2026/11/05Accepted

    Mirogabalin Besilate Tablets

    CYHS2602710

    Fact date: 2026/11/05 · Site observation date: 2026/11/06

    View source ↗
  2. 2026/10/30No longer listed under review

    Brexpiprazole Tablets

    CYHS2502059

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

    Accepted: 2025/06/11

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

    View source ↗
  3. 2026/10/30No longer listed under review

    Brexpiprazole Tablets

    CYHS2502058

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

    Accepted: 2025/06/11

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

    View source ↗
  4. 2026/10/30No longer listed under review

    Brexpiprazole Tablets

    CYHS2502057

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

    Accepted: 2025/06/11

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

    View source ↗

Under review

1 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 CYHS2602710Generic2026/11/05Shanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedCDE ↗

Catalogue holder records

4 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
Tamoxifen Citrate TabletsShanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedShanghai Fu Dan Fu Hua Pharma Co., Ltd. romanized国药准字H310215452025/01/24Drug that passed quality-and-efficacy consistency evaluationCDE ↗
比卡鲁胺片 · No verified English nameShanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedShanghai Fu Dan Fu Hua Pharma Co., Ltd. romanized国药准字H201135352023/06/01Drug that passed quality-and-efficacy consistency evaluationCDE ↗
盐酸赛庚啶片 · No verified English nameShanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedShanghai Fu Dan Fu Hua Pharma Co., Ltd. romanized国药准字H310213722023/02/03Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Carbamazepine TabletsShanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedShanghai Fu Dan Fu Hua Pharma Co., Ltd. romanized国药准字H310213662021/04/01Drug that passed quality-and-efficacy consistency evaluationCDE ↗

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

7 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
氯唑沙宗 · No verified English nameShanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedY20190007961A—CDE ↗
硝酸异山梨酯 · No verified English nameShanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedY20190007718A—CDE ↗
甲磺酸酚妥拉明 · No verified English nameShanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedY20190007660A2024/04/02CDE ↗
比卡鲁胺 · No verified English nameShanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedY20190006571A2025/10/23CDE ↗
氟他胺 · No verified English nameShanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedY20190003953A2025/04/29CDE ↗
石杉碱甲 · No verified English nameShanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedY20190003949A—CDE ↗
枸橼酸他莫昔芬 · No verified English nameShanghai Fu Dan Fu Hua Pharma Co., Ltd. romanizedY20190002964A2025/04/29CDE ↗

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

1 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
Esomeprazole Sodium for Injection CYHB2501211Supplement2025/06/14Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized; Shanghai Fu Dan Fu Hua Pharma 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.