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Company directoryChina company filings

H. Lundbeck A/S

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 e8574e4dd3

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

47 acceptance records as first applicant, grouped into 7 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.

Citalopram Hydrobromide Tablets 6 records · Latest accepted 2026/08/04

Import re-registration · 3Supplement · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2600186Import re-registration2026/08/04H. Lundbeck A/S; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHB2600190Supplement2026/03/23H. Lundbeck A/SCDE ↗
JYHB2200660Supplement2022/12/24H. Lundbeck A/SCDE ↗
JYHZ2100669Import re-registration2021/10/29H. Lundbeck A/S; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHZ2100665Import re-registration2021/10/29H. Lundbeck A/S; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHB2101069Supplement2021/04/28H. Lundbeck A/SCDE ↗
Flupentixol and Melitracen Tablets 2 records · Latest accepted 2026/07/10

Import re-registration · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2600168Import re-registration2026/07/10H. Lundbeck A/SCDE ↗
JYHZ2100651Import re-registration2021/10/14H. Lundbeck A/SCDE ↗
Vortioxetine Hydrobromide Tablets 18 records · Latest accepted 2026/02/15

Supplement · 15Import re-registration · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2600101Supplement2026/02/15H. Lundbeck A/SCDE ↗
JYHB2600100Supplement2026/02/15H. Lundbeck A/SCDE ↗
JYHB2600099Supplement2026/02/15H. Lundbeck A/SCDE ↗
JYHB2400072Supplement2024/02/06H. Lundbeck A/SCDE ↗
JYHB2400071Supplement2024/02/06H. Lundbeck A/SCDE ↗
JYHB2400070Supplement2024/02/06H. Lundbeck A/SCDE ↗
JYHB2300162Supplement2023/03/03H. Lundbeck A/SCDE ↗
JYHB2300161Supplement2023/03/03H. Lundbeck A/SCDE ↗
JYHB2300160Supplement2023/03/03H. Lundbeck A/SCDE ↗
JYHZ2200073Import re-registration2022/03/10H. Lundbeck A/SCDE ↗
JYHZ2200072Import re-registration2022/03/10H. Lundbeck A/SCDE ↗
JYHZ2200071Import re-registration2022/03/10H. Lundbeck A/SCDE ↗
JYHB2101483Supplement2021/10/26H. Lundbeck A/SCDE ↗
JYHB2101482Supplement2021/10/26H. Lundbeck A/SCDE ↗
JYHB2101481Supplement2021/10/26H. Lundbeck A/SCDE ↗
JYHB2100147Supplement2021/02/21H. Lundbeck A/SCDE ↗
JYHB2100146Supplement2021/02/21H. Lundbeck A/SCDE ↗
JYHB2100145Supplement2021/02/21H. Lundbeck A/SCDE ↗
Escitalopram Oxalate Tablets 12 records · Latest accepted 2024/12/04

Supplement · 9Import re-registration · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2400629Supplement2024/12/04H. Lundbeck A/SCDE ↗
JYHB2400628Supplement2024/12/04H. Lundbeck A/SCDE ↗
JYHB2400627Supplement2024/12/04H. Lundbeck A/SCDE ↗
JYHB2400271Supplement2024/06/07H. Lundbeck A/SCDE ↗
JYHB2400270Supplement2024/06/07H. Lundbeck A/SCDE ↗
JYHB2400269Supplement2024/06/07H. Lundbeck A/SCDE ↗
JYHZ2300400Import re-registration2023/10/18H. Lundbeck A/SCDE ↗
JYHZ2300399Import re-registration2023/10/18H. Lundbeck A/SCDE ↗
JYHZ2300128Import re-registration2023/03/09H. Lundbeck A/SCDE ↗
JYHB2101119Supplement2021/05/21H. Lundbeck A/SCDE ↗
JYHB2101118Supplement2021/05/21H. Lundbeck A/SCDE ↗
JYHB2101117Supplement2021/05/21H. Lundbeck A/SCDE ↗
No verified English name 4 records · Latest accepted 2024/03/04

Import · 4

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JXHL2400056Import2024/03/04H. Lundbeck A/SCDE ↗
JXHL2400055Import2024/03/04H. Lundbeck A/SCDE ↗
JXHL2400054Import2024/03/04H. Lundbeck A/SCDE ↗
JXHL2400053Import2024/03/04H. Lundbeck A/SCDE ↗
No verified English name 1 records · Latest accepted 2023/07/13

Import · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JXSL2300128Import2023/07/13H. Lundbeck A/SCDE ↗
Memantine Hydrochloride Tablets 4 records · Latest accepted 2023/02/11

Import · 2Import re-registration · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JXHS2300020Import2023/02/11H. Lundbeck A/S; Rottendorf Pharma GmbH; Lundbeck (Beijing) Pharmaceuticals Consulting CO. LtdCDE ↗
JXHS2300019Import2023/02/11H. Lundbeck A/S; Rottendorf Pharma GmbH; Lundbeck (Beijing) Pharmaceuticals Consulting CO. LtdCDE ↗
JYHZ2200207Import re-registration2022/07/27H. Lundbeck A/S; Rottendorf Pharma GmbH; Lundbeck(Beijing) Pharmaceuticals Consulting CO. LtdCDE ↗
JYHZ2200206Import re-registration2022/07/27H. Lundbeck A/S; Rottendorf Pharma GmbH; Lundbeck (Beijing) Pharmaceuticals Consulting CO. LtdCDE ↗

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
Citalopram Hydrobromide Tablets JYHZ2600186Import re-registration2026/08/04H. Lundbeck A/S; Xian Janssen Pharmaceutical Ltd.CDE ↗
Flupentixol and Melitracen Tablets JYHZ2600168Import re-registration2026/07/10H. Lundbeck A/SCDE ↗

Catalogue holder records

7 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
Vortioxetine Hydrobromide TabletsH.Lundbeck A/SH.Lundbeck A/SH20170381;H201703822017/11/21Imported originator drugCDE ↗
Vortioxetine Hydrobromide TabletsH.Lundbeck A/SH.Lundbeck A/SH20170383;H201703842017/11/21Imported originator drugCDE ↗
Escitalopram Oxalate TabletsH. Lundbeck A/SH.Lundbeck A/SH201401212009/04/16Imported originator drugCDE ↗
Escitalopram Oxalate TabletsH. Lundbeck A/SH.Lundbeck A/SH201501612005/08/31Imported originator drugCDE ↗
Escitalopram Oxalate TabletsH. Lundbeck A/SH.Lundbeck A/SH201501632005/08/31Imported originator drugCDE ↗
Citalopram Hydrobromide TabletsH. Lundbeck A/SH. Lundbeck A/SH201703181999/11/20Imported originator drugCDE ↗
Flupentixol and Melitracen TabletsH.Lundbeck A/SH.Lundbeck A/SH201711041999/09/17Imported 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

0 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 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

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 2026/11/11 06:42.

Co-applicant records
Drug Acceptance numberApplication typeAcceptedCompany / applicantView source
No verified English name JTS2200095Not stated by source2022/10/20Vetter Pharma-Fertigung GmbH & Co. KG; H. Lundbeck A/S; Ling Bei (Beijing) Pharmaceuticals Xin Xi Zi Xun 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.