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Henan Ke Lun Pharma 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 5a345946b7

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

27 acceptance records as first applicant, grouped into 11 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.

注射用头孢美唑钠/氯化钠注射液 · No verified English name 2 records · Latest accepted 2025/06/27

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2501269Supplement2025/06/27Henan Ke Lun Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2401331Supplement2024/08/27Henan Ke Lun Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
Penehyclidine Hydrochloride Injection 1 records · Latest accepted 2025/05/30

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2501106Supplement2025/05/30Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
Progesterone Injection 2 records · Latest accepted 2025/04/24

Generic · 1Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501540Generic2025/04/24Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
CYHB2450553Supplement2024/11/05Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
Diclofenac Diethylamine Emulgel 1 records · Latest accepted 2025/04/23

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501522Generic2025/04/23Henan Ke Lun Pharma Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd.CDE ↗
Lidocaine and Prilocaine Cream 1 records · Latest accepted 2024/11/26

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2401985Supplement2024/11/26Henan Ke Lun Pharma Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanizedCDE ↗
Mivacurium Chloride Injection 2 records · Latest accepted 2024/11/05

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2403747Generic2024/11/05Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
CYHS2403746Generic2024/11/05Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
Nicardipine Hydrochloride Injection 1 records · Latest accepted 2024/01/23

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400305Generic2024/01/23Henan Ke Lun Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
氯化钠注射液 · No verified English name 5 records · Latest accepted 2023/07/11

Supplement · 5

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2301535Supplement2023/07/11Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
CYHB2301177Supplement2023/05/23Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
CYHB2101740Supplement2021/08/31Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
CYHB2101739Supplement2021/08/31Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
CYHB2101738Supplement2021/08/31Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
葡萄糖注射液 · No verified English name 8 records · Latest accepted 2023/07/11

Supplement · 8

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2301531Supplement2023/07/11Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
CYHB2301178Supplement2023/05/23Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
CYHB2100246Supplement2021/02/10Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
CYHB2100245Supplement2021/02/10Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
CYHB2100244Supplement2021/02/10Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
CYHB2100235Supplement2021/02/09Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
CYHB2100234Supplement2021/02/09Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
CYHB2100233Supplement2021/02/09Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
Piracetam Injection 1 records · Latest accepted 2022/09/01

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2201429Generic2022/09/01Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
葡萄糖氯化钠注射液 · No verified English name 3 records · Latest accepted 2021/02/10

Supplement · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2100243Supplement2021/02/10Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
CYHB2100242Supplement2021/02/10Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
CYHB2100241Supplement2021/02/09Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗

Changes in the last 90 days

1 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.

No longer listed under review: 1 application

  1. 2026/10/28No longer listed under review

    Diclofenac Diethylamine Emulgel

    CYHS2501522

    Fact date: 2026/10/28 · Site observation date: 2026/10/28

    Accepted: 2025/04/23

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗

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
Progesterone Injection CYHS2501540Generic2025/04/24Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗

Catalogue holder records

6 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
Mivacurium Chloride InjectionHenan Ke Lun Pharma Co., Ltd. romanizedHenan Ke Lun Pharma Co., Ltd. romanized国药准字H202654622026/08/04Generic approved under the new chemical-drug registration classificationCDE ↗
Mivacurium Chloride InjectionHenan Ke Lun Pharma Co., Ltd. romanizedHenan Ke Lun Pharma Co., Ltd. romanized国药准字H202654632026/08/04Generic approved under the new chemical-drug registration classificationCDE ↗
Piracetam InjectionHenan Ke Lun Pharma Co., Ltd. romanizedHenan Ke Lun Pharma Co., Ltd. romanized国药准字H202431052024/01/30Generic approved under the new chemical-drug registration classificationCDE ↗
Multiple Electrolytes Injection(Ⅱ)Henan Ke Lun Pharma Co., Ltd. romanizedHenan Ke Lun Pharma Co., Ltd. romanized国药准字H202334522023/04/11Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Multiple Electrolytes Injection(Ⅱ)Henan Ke Lun Pharma Co., Ltd. romanizedHenan Ke Lun Pharma Co., Ltd. romanized国药准字H202334302023/04/11Generic approved under the new chemical-drug registration classificationCDE ↗
Sodium Acetate Ringer's InjectionHenan Ke Lun Pharma Co., Ltd. romanizedHenan Ke Lun Pharma Co., Ltd. romanized国药准字H202330132023/01/09Generic 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

1 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
尼莫地平 · No verified English nameHenan Ke Lun Pharma Co., Ltd. romanizedY20190004746A2024/11/01CDE ↗

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

36 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
氯化钠注射液 · No verified English name CYHB2602051Supplement2026/11/11Sichuan Kelun Pharmaceutical Co., Ltd.; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
葡萄糖注射液 · No verified English name CYHB2601001Supplement2026/05/27Sichuan Kelun Pharmaceutical Co., Ltd.; Guizhou Ke Lun Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanizedCDE ↗
Dexamethasone Sodium Phosphate Injection CYHB2600588Supplement2026/03/25Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
Dexamethasone Sodium Phosphate Injection CYHB2600587Supplement2026/03/25Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
曲克芦丁注射液 · No verified English name CYHB2600512Supplement2026/03/13CISEN PHARMACEUTICAL CO., LTD.; Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
复方黄体酮注射液 · No verified English name CYHB2502388Supplement2025/11/22Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
替硝唑氯化钠注射液 · No verified English name CYHB2502338Supplement2025/11/12Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Guizhou Ke Lun Pharma Co., Ltd. romanizedCDE ↗
丙酸睾酮注射液 · No verified English name CYHB2502266Supplement2025/11/04Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
盐酸左氧氟沙星氯化钠注射液 · No verified English name CYHB2501829Supplement2025/09/13Sichuan Kelun Pharmaceutical Co., Ltd.; Guangdong Ke Hong Pharma Co., Ltd. romanized; Guizhou Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized; Jiangxi Ke Lun Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
氯化钠注射液 · No verified English name CYHB2501534Supplement2025/08/02Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Guizhou Ke Lun Pharma Co., Ltd. romanizedCDE ↗
氯化钠注射液 · No verified English name CYHB2501533Supplement2025/08/02Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Guizhou Ke Lun Pharma Co., Ltd. romanizedCDE ↗
氯化钠注射液 · No verified English name CYHB2501532Supplement2025/08/02Sichuan Kelun Pharmaceutical Co., Ltd.; Guizhou Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
葡萄糖注射液 · No verified English name CYHB2501528Supplement2025/08/02Sichuan Kelun Pharmaceutical Co., Ltd.; Guizhou Ke Lun Pharma Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
葡萄糖注射液 · No verified English name CYHB2501527Supplement2025/08/02Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Guizhou Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanizedCDE ↗
葡萄糖注射液 · No verified English name CYHB2501525Supplement2025/08/02Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Guizhou Ke Lun Pharma Co., Ltd. romanizedCDE ↗
Metronidazole and Sodium Chloride Injection CYHB2501505Supplement2025/07/30Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
氯化钠注射液 · No verified English name CYHB2500725Supplement2025/04/11Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Heilongjiang Bo Yu Pharmaceutical Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanizedCDE ↗
氯化钠注射液 · No verified English name CYHB2500724Supplement2025/04/11Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Heilongjiang Bo Yu Pharmaceutical Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanizedCDE ↗
氯化钠注射液 · No verified English name CYHB2500723Supplement2025/04/11Sichuan Kelun Pharmaceutical Co., Ltd.; Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanizedCDE ↗
氯化钠注射液 · No verified English name CYHB2500722Supplement2025/04/11Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Heilongjiang Bo Yu Pharmaceutical Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanizedCDE ↗
氯化钠注射液 · No verified English name CYHB2500721Supplement2025/04/11Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanizedCDE ↗
葡萄糖注射液 · No verified English name CYHB2500585Supplement2025/03/21Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanizedCDE ↗
葡萄糖注射液 · No verified English name CYHB2500584Supplement2025/03/21Sichuan Kelun Pharmaceutical Co., Ltd.; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanized; Heilongjiang Bo Yu Pharmaceutical Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanizedCDE ↗
葡萄糖注射液 · No verified English name CYHB2500583Supplement2025/03/21Sichuan Kelun Pharmaceutical Co., Ltd.; Shandong Ke Lun Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
葡萄糖注射液 · No verified English name CYHB2500582Supplement2025/03/21Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanizedCDE ↗
葡萄糖注射液 · No verified English name CYHB2500581Supplement2025/03/21Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanizedCDE ↗
氯化钠注射液 · No verified English name CYHB2500021Supplement2025/01/04Sichuan Kelun Pharmaceutical Co., Ltd.; Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanizedCDE ↗
Betamethasone Sodium Phosphate Injection CYHS2404040Generic2024/11/23Anhui Mei Lai Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
Progesterone Injection CYHS2403721Generic2024/11/01Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
Dexamethasone Sodium Phosphate Injection CYHS2402133Generic2024/07/12Anhui Mei Lai Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
维生素B6注射液 · No verified English name CYHS2401646Generic2024/06/01Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
水溶性黄体酮注射液 · No verified English name CYHS2400541Generic2024/02/07Shijiazhuang No.4 Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
Penehyclidine Hydrochloride Injection CYHS2400366Generic2024/01/27Guangxi Ke Lun Pharmaceutical Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
Potassium Chloride Injection CYHS2302276Generic2023/08/26Guangdong Ke Hong Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
Potassium Chloride Injection CYHS2302275Generic2023/08/26Guangdong Ke Hong Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanizedCDE ↗
Sodium Acetate Ringer's Injection CYHB2301599Supplement2023/07/14Fujian Pin Teng Pharma Co., Ltd. romanized; Henan Ke Lun Pharma 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.