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Company directoryChina company filings

Guangxi Ke Lun Pharmaceutical 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 1620db91a7

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

10 acceptance records as first applicant, grouped into 5 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.

Ilaprazole Enteric-coated Tablets 1 records · Latest accepted 2025/10/16

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2503699Generic2025/10/16Guangxi Ke Lun Pharmaceutical Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.CDE ↗
Penehyclidine Hydrochloride Injection 1 records · Latest accepted 2024/01/27

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400366Generic2024/01/27Guangxi Ke Lun Pharmaceutical Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
Cefotaxime Sodium For Injection 3 records · Latest accepted 2023/01/05

Supplement · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2350015Supplement2023/01/05Guangxi Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2350014Supplement2023/01/05Guangxi Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2350013Supplement2023/01/05Guangxi Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
注射用头孢硫脒 · No verified English name 4 records · Latest accepted 2022/09/20

Supplement · 4

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2201691Supplement2022/09/20Guangxi Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2200197Supplement2022/01/25Guangxi Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2101199Supplement2021/05/08Guangxi Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2101198Supplement2021/05/08Guangxi Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
Ceftazidime And Avibactam Sodium For Injection 1 records · Latest accepted 2022/01/27

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2200206Generic2022/01/27Guangxi 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

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
Ilaprazole Enteric-coated Tablets CYHS2503699Generic2025/10/16Guangxi Ke Lun Pharmaceutical Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.CDE ↗

Catalogue holder records

5 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
Penehyclidine Hydrochloride InjectionGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedHenan Ke Lun Pharma Co., Ltd. romanized国药准字H202539662025/04/22Generic approved under the new chemical-drug registration classificationCDE ↗
Cefotaxime Sodium For InjectionGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedGuangxi Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H450202442024/06/05Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Cefotaxime Sodium For InjectionGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedGuangxi Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H450202452024/06/05Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Cefotaxime Sodium For InjectionGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedGuangxi Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H200132442024/06/05Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Ceftazidime And Avibactam Sodium For InjectionGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedGuangxi Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H202342912023/10/12Generic 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

16 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
头孢曲松钠 · No verified English nameGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedY20230000703A2026/02/26CDE ↗
头孢噻肟钠 · No verified English nameGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedY20220000940A2024/05/28CDE ↗
阿维巴坦钠 · No verified English nameGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedY20210001071A2024/06/06CDE ↗
头孢他啶 · No verified English nameGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedY20190008004A2024/11/28CDE ↗
头孢噻吩钠 · No verified English nameGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedY20190007124A2024/11/28CDE ↗
头孢替唑钠 · No verified English nameGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedY20190007028A2024/11/28CDE ↗
头孢硫脒 · No verified English nameGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedY20190006190A2024/11/28CDE ↗
头孢氨苄 · No verified English nameGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedY20190006140A2024/11/28CDE ↗
头孢拉定(口服粉) · No verified English nameGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedY20190006138A2024/11/28CDE ↗
头孢氨苄 · No verified English nameGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedY20190006075A2024/11/28CDE ↗
头孢呋辛钠 · No verified English nameGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedY20190005334A2024/11/28CDE ↗
头孢哌酮钠 · No verified English nameGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedY20190004454A2024/11/28CDE ↗
头孢曲松钠 · No verified English nameGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedY20190004441A2024/11/28CDE ↗
头孢噻肟钠 · No verified English nameGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedY20190004439A2025/04/29CDE ↗
头孢米诺钠 · No verified English nameGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedY20190004438A2024/11/28CDE ↗
硫酸头孢匹罗 · No verified English nameGuangxi Ke Lun Pharmaceutical Co., Ltd. romanizedY20190004430A2024/11/28CDE ↗

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 2026/11/13 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: 2026/11/13 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.