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Company directoryChina company filings

Otsuka Pharmaceutical Co.,Ltd.

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 c77b8e392f

Complete CDE snapshot
2026/11/11 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 2026/11/11 06:42.

Drug filings

14 acceptance records as first applicant, grouped into 3 source drug names. Source data as of 2026/11/11 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.

No verified English name 6 records · Latest accepted 2025/09/25

Import · 6

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JXHS2500114Import2025/09/25Otsuka Pharmaceutical Co.,Ltd.; CMIC CMO Co.,Ltd. Toyama Plant; Otsuka Beijing Research InstituteCDE ↗
JXHS2500113Import2025/09/25Otsuka Pharmaceutical Co.,Ltd.; CMIC CMO Co.,Ltd. Toyama Plant; Otsuka Beijing Research InstituteCDE ↗
JXHS2500112Import2025/09/25Otsuka Pharmaceutical Co.,Ltd.; CMIC CMO Co.,Ltd. Toyama Plant; Otsuka Beijing Research InstituteCDE ↗
JXHS2500111Import2025/09/25Otsuka Pharmaceutical Co.,Ltd.; CMIC CMO Co.,Ltd. Toyama Plant; Otsuka Beijing Research InstituteCDE ↗
JXHS2500110Import2025/09/25Otsuka Pharmaceutical Co.,Ltd.; CMIC CMO Co.,Ltd. Toyama Plant; Otsuka Beijing Research InstituteCDE ↗
JXHS2500109Import2025/09/25Otsuka Pharmaceutical Co.,Ltd.; CMIC CMO Co.,Ltd. Toyama Plant; Otsuka Beijing Research InstituteCDE ↗
Brexpiprazole Tablets 6 records · Latest accepted 2025/04/17

Supplement · 3Import · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2500225Supplement2025/04/17Otsuka Pharmaceutical Co.,Ltd.; Otsuka Pharmaceutical Co. Ltd. Second Tokushima Factory; Otsuka Pharmaceutical Co. Ltd. Tokushima FactoryCDE ↗
JYHB2500224Supplement2025/04/17Otsuka Pharmaceutical Co.,Ltd.; Otsuka Pharmaceutical Co. Ltd. Second Tokushima Factory; Otsuka Pharmaceutical Co. Ltd. Tokushima FactoryCDE ↗
JYHB2500223Supplement2025/04/17Otsuka Pharmaceutical Co.,Ltd.; Otsuka Pharmaceutical Co. Ltd. Second Tokushima Factory; Otsuka Pharmaceutical Co. Ltd. Tokushima FactoryCDE ↗
JXHS2200124Import2022/12/24Otsuka Pharmaceutical Co.,Ltd.; Otsuka Pharmaceutical Co. Ltd. Tokushima Factory; Otsuka Beijing Research InstituteCDE ↗
JXHS2200123Import2022/12/24Otsuka Pharmaceutical Co.,Ltd.; Otsuka Pharmaceutical Co. Ltd. Tokushima Factory; Otsuka Beijing Research InstituteCDE ↗
JXHS2200122Import2022/12/24Otsuka Pharmaceutical Co.,Ltd.; Otsuka Pharmaceutical Co. Ltd. Tokushima Factory; Otsuka Beijing Research InstituteCDE ↗
No verified English name 2 records · Latest accepted 2023/12/15

Import · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JXHS2300122Import2023/12/15Otsuka Pharmaceutical Co.,Ltd.; Fuji Yakuhin Co. Ltd. Toyama Factory; Otsuka Beijing Research InsitituteCDE ↗
JXHS2300121Import2023/12/15Otsuka Pharmaceutical Co.,Ltd.; Fuji Yakuhin Co. Ltd. Toyama Factory; Otsuka Beijing Research InsitituteCDE ↗

Changes in the last 90 days

0 events from 2026/08/14 to 2026/11/11. CDE data as of 2026/11/11 06:42; NMPA data as of 2026/11/10 18:31.

This source was last successfully updated at 2026/11/10 18:31; 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.

  1. No matching records were found in the currently loaded source data; coverage dates are listed below.

Under review

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

Under review
Drug Acceptance numberApplication typeAcceptedCompany / applicantView source
No verified English name JXHS2500114Import2025/09/25Otsuka Pharmaceutical Co.,Ltd.; CMIC CMO Co.,Ltd. Toyama Plant; Otsuka Beijing Research InstituteCDE ↗
No verified English name JXHS2500113Import2025/09/25Otsuka Pharmaceutical Co.,Ltd.; CMIC CMO Co.,Ltd. Toyama Plant; Otsuka Beijing Research InstituteCDE ↗
No verified English name JXHS2500112Import2025/09/25Otsuka Pharmaceutical Co.,Ltd.; CMIC CMO Co.,Ltd. Toyama Plant; Otsuka Beijing Research InstituteCDE ↗
No verified English name JXHS2500111Import2025/09/25Otsuka Pharmaceutical Co.,Ltd.; CMIC CMO Co.,Ltd. Toyama Plant; Otsuka Beijing Research InstituteCDE ↗
No verified English name JXHS2500110Import2025/09/25Otsuka Pharmaceutical Co.,Ltd.; CMIC CMO Co.,Ltd. Toyama Plant; Otsuka Beijing Research InstituteCDE ↗
No verified English name JXHS2500109Import2025/09/25Otsuka Pharmaceutical Co.,Ltd.; CMIC CMO Co.,Ltd. Toyama Plant; Otsuka Beijing Research InstituteCDE ↗

Catalogue holder records

2 loaded active catalogue records whose holder name matches this source company name. Source data as of 2026/11/11 06:38. Manufacturer-only records are excluded.

DrugMarketing authorization holderManufacturerApproval numberApprovedCatalogue category (source text)View source
Ponatinib TabletsOtsuka Pharmaceutical Co., Ltd.Patheon Inc.Toronto Region Operations国药准字HJ202400902024/09/03Imported originator drugCDE ↗
Busulfan InjectionOtsuka Pharmaceutical Co.,Ltd.Baxter Oncology GmbHH201703082003/12/12Imported originator drugCDE ↗

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

5 loaded active API registrations whose first registered company matches this source company name. Source data as of 2026/11/11 06:40.

NameCompany / applicantRegistration numberStatusSource update dateView source
No verified English nameOtsuka Pharmaceutical Co., Ltd.Y20209990045A2025/11/06CDE ↗
No verified English nameOtsuka Pharmaceutical Co., Ltd.Y20209990044A2025/11/06CDE ↗
No verified English nameOtsuka Pharmaceutical Co.,Ltd.Y20190009200A2024/11/12CDE ↗
No verified English nameOtsuka Pharmaceutical Co., Ltd.Y20190009151A2026/05/20CDE ↗
No verified English nameOtsuka Pharmaceutical Co., Ltd.Y20170001495A2024/09/30CDE ↗

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

0 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 2026/11/11 06:42.

Co-applicant records
Drug Acceptance numberApplication typeAcceptedCompany / applicantView source
No matching records were found in the currently loaded source data; coverage dates are listed below.

How current is each source?

CDE acceptances and review
Last successful update: 2026/11/11 06:42
Chemical-drug catalogue
Last successful update: 2026/11/11 06:38
Full API register
Last successful update: 2026/11/11 06:40
NMPA drug delivery notices
Last successful update: 2026/11/10 18:31 · Current coverage may be incomplete

First index-page publication dates: — to —; 0 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.

Drug names use verified official English names only. Missing names are shown as No verified English name, linking to a Chinese page. Company labels use verified official names, Latin source names, then fixed-rule transliterations marked romanized. Original statutory reference numbers are the sole visible Chinese exception.

Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Chinese free text is not displayed; use the source links or source-name columns in CSV exports.