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Sichuan Ke Lun Drug Research Institute 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 76c17ef611

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

26 acceptance records as first applicant, grouped into 16 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.

注射用多西他赛(白蛋白结合型) · No verified English name 1 records · Latest accepted 2022/09/22

New drug · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CXHL2200716New drug2022/09/22Sichuan Ke Lun Drug Research Institute Co., Ltd. romanizedCDE ↗
布瑞哌唑口溶膜 · No verified English name 2 records · Latest accepted 2022/08/12

New drug · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CXHL2200586New drug2022/08/12Sichuan Ke Lun Drug Research Institute Co., Ltd. romanizedCDE ↗
CXHL2200585New drug2022/08/12Sichuan Ke Lun Drug Research Institute Co., Ltd. romanizedCDE ↗
Enzalutamide Tablets 1 records · Latest accepted 2022/05/28

New drug · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CXHL2200339New drug2022/05/28Sichuan Ke Lun Drug Research Institute Co., Ltd. romanizedCDE ↗
盐酸左沙丁胺醇雾化吸入溶液 · No verified English name 3 records · Latest accepted 2022/04/19

Generic · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2200613Generic2022/04/19Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2200612Generic2022/04/19Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2200611Generic2022/04/19Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
Regorafenib Tablets 1 records · Latest accepted 2022/01/28

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2200217Generic2022/01/28Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
Sorafenib Tosylate Tablets 1 records · Latest accepted 2022/01/24

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2200167Generic2022/01/24Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
Compound Ipratropium Bromide Solution For Inhalation 1 records · Latest accepted 2022/01/11

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2200044Generic2022/01/11Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
Nintedanib Esilate Soft Capsules 2 records · Latest accepted 2021/12/17

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2102199Generic2021/12/17Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.CDE ↗
CYHS2102198Generic2021/12/17Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.CDE ↗
Obeticholic Acid Tablets 2 records · Latest accepted 2021/11/16

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHL2101040Generic2021/11/16Sichuan Ke Lun Drug Research Institute Co., Ltd. romanizedCDE ↗
CYHL2101039Generic2021/11/16Sichuan Ke Lun Drug Research Institute Co., Ltd. romanizedCDE ↗
Teneligliptin Hydrobromide Hydrate Tablets 1 records · Latest accepted 2021/11/10

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2102004Generic2021/11/10Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.CDE ↗
Palonosetron Hydrochloride Injection 2 records · Latest accepted 2021/09/16

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2101724Generic2021/09/16Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2101723Generic2021/09/16Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
Pregabalin Capsules 2 records · Latest accepted 2021/09/02

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2101676Generic2021/09/02Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.CDE ↗
CYHS2101675Generic2021/09/02Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.CDE ↗
硫酸特布他林雾化吸入用溶液 · No verified English name 1 records · Latest accepted 2021/08/24

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2101627Generic2021/08/24Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
Tofacitinib Citrate Extended Release tablets 1 records · Latest accepted 2021/08/18

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2101602Generic2021/08/18Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.CDE ↗
Sacubitril Valsartan Sodium Tablets 2 records · Latest accepted 2021/06/11

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2101286Generic2021/06/11Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.CDE ↗
CYHS2101285Generic2021/06/11Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.CDE ↗
Palbociclib Capsules 3 records · Latest accepted 2021/04/15

Generic · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2101063Generic2021/04/15Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2101062Generic2021/04/15Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2101061Generic2021/04/15Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗

Changes in the last 90 days

0 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.

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

Under review

0 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
No matching records were found in the currently loaded source data; coverage dates are listed below.

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
Tofacitinib Citrate Extended Release tabletsSichuan Ke Lun Drug Research Institute Co., Ltd. romanizedSichuan Kelun Pharmaceutical Co., Ltd.国药准字H202335682023/05/19Generic approved under the new chemical-drug registration classificationCDE ↗
Pregabalin CapsulesSichuan Ke Lun Drug Research Institute Co., Ltd. romanizedSichuan Kelun Pharmaceutical Co., Ltd.国药准字H202331342023/02/07Generic approved under the new chemical-drug registration classificationCDE ↗
Pregabalin CapsulesSichuan Ke Lun Drug Research Institute Co., Ltd. romanizedSichuan Kelun Pharmaceutical Co., Ltd.国药准字H202331332023/02/07Generic approved under the new chemical-drug registration classificationCDE ↗
Palbociclib CapsulesSichuan Ke Lun Drug Research Institute Co., Ltd. romanizedHunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H202239352022/12/30Generic approved under the new chemical-drug registration classificationCDE ↗
Palbociclib CapsulesSichuan Ke Lun Drug Research Institute Co., Ltd. romanizedHunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H202239342022/12/30Generic approved under the new chemical-drug registration classificationCDE ↗
Palbociclib CapsulesSichuan Ke Lun Drug Research Institute Co., Ltd. romanizedHunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H202239362022/12/30Generic approved under the new chemical-drug registration classificationCDE ↗
Palonosetron Hydrochloride InjectionSichuan Ke Lun Drug Research Institute Co., Ltd. romanizedHunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H202234482022/06/28Generic approved under the new chemical-drug registration classificationCDE ↗
Palonosetron Hydrochloride InjectionSichuan Ke Lun Drug Research Institute Co., Ltd. romanizedHunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H202234492022/06/28Generic 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

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
KL0011034注射液 · No verified English name CXHL2501370New drug2025/12/10Hunan Ke Lun Pharmaceutical Co., Ltd. romanized; Sichuan Ke Lun Drug Research Institute 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.