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CHEPLAPHARM Arzneimittel GmbH

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 fe26389b53

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

18 acceptance records as first applicant, grouped into 9 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.

Clonazepam Tablets 1 records · Latest accepted 2026/08/11

Import · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JXHS2600087Import2026/08/11CHEPLAPHARM Arzneimittel GmbH; Patheon Inc.; Zhejiang Hesenna Medicine CO. LTDCDE ↗
Gemcitabine Hydrochloride for Injection 2 records · Latest accepted 2026/02/10

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2600091Supplement2026/02/10CHEPLAPHARM Arzneimittel GmbH; Vianex S.A.-PlantCCDE ↗
JYHB2600090Supplement2026/02/10CHEPLAPHARM Arzneimittel GmbH; Vianex S.A.-PlantCCDE ↗
No verified English name 2 records · Latest accepted 2025/08/26

Import · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JXHS2500091Import2025/08/26CHEPLAPHARM Arzneimittel GmbH; CENEXI SAS; Benova (Tianjin) Pharma Co Ltd.CDE ↗
JXHS2400045Import2024/07/03CHEPLAPHARM Arzneimittel GmbH; CENEXI SAS; Benova (Tianjin) Pharma Co Ltd.CDE ↗
Paclitaxel Injection 3 records · Latest accepted 2025/07/12

Import re-registration · 1Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2500144Import re-registration2025/07/12CHEPLAPHARM Arzneimittel GmbH; Latina Pharma S.p.A.; Beijing Anlongtai Technology Company LimitedCDE ↗
JYHB2500183Supplement2025/03/27CHEPLAPHARM Arzneimittel GmbH; Latina Pharma S.p.A.CDE ↗
JYHB2300522Supplement2023/09/14CHEPLAPHARM Arzneimittel GmbH; Corden Pharma Latina S.P.A.CDE ↗
Valganciclovir Hydrochloride Tablets 2 records · Latest accepted 2024/05/23

Import re-registration · 1Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2400130Import re-registration2024/05/23CHEPLAPHARM Arzneimittel GmbH; Patheon Inc.CDE ↗
JYHB2200503Supplement2022/09/15CHEPLAPHARM Arzneimittel GmbH; Patheon Inc.CDE ↗
Midazolam Maleate Tablets 1 records · Latest accepted 2024/02/01

Import re-registration · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2400035Import re-registration2024/02/01CHEPLAPHARM Arzneimittel GmbH; Recipharm Leganés S.L.U.; Zhejiang Medical Technology Development Co. LTD.CDE ↗
Ganciclovir For Injection 1 records · Latest accepted 2023/04/29

Import re-registration · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2300206Import re-registration2023/04/29CHEPLAPHARM Arzneimittel GmbH; BSP Pharmaceuticals S.p.A.CDE ↗
Alfacalcidol Soft Capsules 4 records · Latest accepted 2023/02/22

Import re-registration · 2Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2300092Import re-registration2023/02/22CHEPLAPHARM Arzneimittel GmbH; LEO Pharma A/S; GreenPine Pharma Group Co. Ltd.CDE ↗
JYHZ2300091Import re-registration2023/02/22CHEPLAPHARM Arzneimittel GmbH; LEO Pharma A/S; GreenPine Pharma Group Co. Ltd.CDE ↗
JYHB2200125Supplement2022/03/10CHEPLAPHARM Arzneimittel GmbH; LEO Pharma A/SCDE ↗
JYHB2200124Supplement2022/03/10CHEPLAPHARM Arzneimittel GmbH; LEO Pharma A/SCDE ↗
No verified English name 2 records · Latest accepted 2023/02/14

Import re-registration · 1Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2300068Import re-registration2023/02/14CHEPLAPHARM Arzneimittel GmbH; LEO Pharma A/S; GreenPine Pharma Group Co. Ltd.CDE ↗
JYHB2200074Supplement2022/02/15CHEPLAPHARM Arzneimittel GmbH; LEO Pharma A/SCDE ↗

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

2 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
Clonazepam Tablets JXHS2600087Import2026/08/11CHEPLAPHARM Arzneimittel GmbH; Patheon Inc.; Zhejiang Hesenna Medicine CO. LTDCDE ↗
No verified English name JXHS2500091Import2025/08/26CHEPLAPHARM Arzneimittel GmbH; CENEXI SAS; Benova (Tianjin) Pharma Co Ltd.CDE ↗

Catalogue holder records

1 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
Ganciclovir For InjectionCHEPLAPHARM Arzneimittel GmbHBSP Pharmaceuticals S.p.A.H201303741996/09/11Imported 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

2 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 nameCHEPLAPHARM Arzneimittel GmbHY20190009176A2026/03/20CDE ↗
No verified English nameCHEPLAPHARM Arzneimittel GmbHY20190009175A2026/03/20CDE ↗

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

3 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
Quetiapine Fumarate Tablets JTH2600102Not stated by source2026/05/27Klocke Pharma-Service GmbH; CHEPLAPHARM Arzneimittel GmbH; Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanizedCDE ↗
No verified English name JTH2400015Not stated by source2024/02/03Alcami Carolinas Corporation; CHEPLAPHARM Arzneimittel GmbH; Ou Kang Wei Shi Biopharmaceuticals (Shanghai) Co., Ltd. romanizedCDE ↗
No verified English name JTH2300064Not stated by source2023/03/03Alcami Carolinas Corporation; CHEPLAPHARM Arzneimittel GmbH; Ou Kang Wei Shi Biopharmaceuticals (Shanghai) Co., Ltd. romanizedCDE ↗

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.