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Ren He Xi De Long 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 fc82c57620

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

23 acceptance records as first applicant, grouped into 13 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.

Nilotinib Capsules 4 records · Latest accepted 2026/09/10

Generic · 4

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2602263Generic2026/09/10Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
CYHS2602262Generic2026/09/10Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
CYHS2502247Generic2025/06/23Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
CYHS2502246Generic2025/06/23Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
Vincriscristine Sulfate Injection 1 records · Latest accepted 2026/02/25

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2600496Generic2026/02/25Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
Carboplatin Injection 2 records · Latest accepted 2025/09/28

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2503546Generic2025/09/28Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
CYHS2503544Generic2025/09/28Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
Pazopanib Tablets 1 records · Latest accepted 2025/06/14

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2502126Generic2025/06/14Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
Methotrexate For Injection 3 records · Latest accepted 2024/10/29

Supplement · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2401736Supplement2024/10/29Ren He Xi De Long Pharma Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanizedCDE ↗
CYHB2350239Supplement2023/03/08Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
CYHB2350238Supplement2023/03/08Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
Ibrutinib Capsules 1 records · Latest accepted 2024/10/11

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2403368Generic2024/10/11Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
Sorafenib Tosylate Tablets 1 records · Latest accepted 2024/07/02

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2401962Generic2024/07/02Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
Cytarabine for Injection 2 records · Latest accepted 2024/05/08

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2401365Generic2024/05/08Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
CYHS2401363Generic2024/05/08Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
Regorafenib Tablets 1 records · Latest accepted 2024/03/14

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400835Generic2024/03/14Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
Pemetrexed Disodium for Injection 2 records · Latest accepted 2023/06/03

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2301520Generic2023/06/03Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
CYHS2301519Generic2023/06/03Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
Temozolomide Capsules 2 records · Latest accepted 2022/08/11

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2201286Generic2022/08/11Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
CYHS2201285Generic2022/08/11Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
Bortezomib For Injection 1 records · Latest accepted 2021/11/17

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2102042Generic2021/11/17Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
Irinotecan Hydrochloride Injection 2 records · Latest accepted 2021/08/10

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2101545Generic2021/08/10Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
CYHS2101544Generic2021/08/10Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗

Changes in the last 90 days

3 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.

Marketing application approved: 1 applicationAccepted: 2 applications

  1. 2026/10/20Marketing application approved

    Pazopanib Tablets

    CYHS2502126 · 国药准字H20266356

    Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03

    View source · Table row 71 ↗
  2. 2026/09/10Accepted

    Nilotinib Capsules

    CYHS2602263

    Fact date: 2026/09/10 · Site observation date: 2026/10/22

    View source ↗
  3. 2026/09/10Accepted

    Nilotinib Capsules

    CYHS2602262

    Fact date: 2026/09/10 · Site observation date: 2026/10/22

    View source ↗

Under review

5 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
Nilotinib Capsules CYHS2602263Generic2026/09/10Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
Nilotinib Capsules CYHS2602262Generic2026/09/10Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
Vincriscristine Sulfate Injection CYHS2600496Generic2026/02/25Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
Carboplatin Injection CYHS2503546Generic2025/09/28Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗
Carboplatin Injection CYHS2503544Generic2025/09/28Ren He Xi De Long Pharma Co., Ltd. romanizedCDE ↗

Catalogue holder records

11 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
Methotrexate For InjectionRen He Xi De Long Pharma Co., Ltd. romanizedShanxi Pu De Pharma Co., Ltd. romanized国药准字H202691022026/04/29Generic approved under the new chemical-drug registration classificationCDE ↗
Regorafenib TabletsRen He Xi De Long Pharma Co., Ltd. romanizedRen He Xi De Long Pharma Co., Ltd. romanized国药准字H202555712025/09/23Generic approved under the new chemical-drug registration classificationCDE ↗
Cytarabine for InjectionRen He Xi De Long Pharma Co., Ltd. romanizedRen He Xi De Long Pharma Co., Ltd. romanized国药准字H202548672025/07/15Not stated by sourceCDE ↗
Cytarabine for InjectionRen He Xi De Long Pharma Co., Ltd. romanizedRen He Xi De Long Pharma Co., Ltd. romanized国药准字H202548662025/07/15Generic approved under the new chemical-drug registration classificationCDE ↗
Pemetrexed Disodium for InjectionRen He Xi De Long Pharma Co., Ltd. romanizedRen He Xi De Long Pharma Co., Ltd. romanized国药准字H202492902024/11/05Generic approved under the new chemical-drug registration classificationCDE ↗
Temozolomide CapsulesRen He Xi De Long Pharma Co., Ltd. romanizedRen He Xi De Long Pharma Co., Ltd. romanized国药准字H202447252024/08/27Generic approved under the new chemical-drug registration classificationCDE ↗
Temozolomide CapsulesRen He Xi De Long Pharma Co., Ltd. romanizedRen He Xi De Long Pharma Co., Ltd. romanized国药准 字H202447262024/08/27Generic approved under the new chemical-drug registration classificationCDE ↗
Bortezomib For InjectionRen He Xi De Long Pharma Co., Ltd. romanizedRen He Xi De Long Pharma Co., Ltd. romanized国药准字H202445872024/07/30Generic approved under the new chemical-drug registration classificationCDE ↗
Methotrexate For InjectionRen He Xi De Long Pharma Co., Ltd. romanizedRen He Xi De Long Pharma Co., Ltd. romanized国药准字H200742312024/04/15Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Irinotecan Hydrochloride InjectionRen He Xi De Long Pharma Co., Ltd. romanizedRen He Xi De Long Pharma Co., Ltd. romanized国药准字H202239102022/11/30Generic approved under the new chemical-drug registration classificationCDE ↗
Irinotecan Hydrochloride InjectionRen He Xi De Long Pharma Co., Ltd. romanizedRen He Xi De Long Pharma Co., Ltd. romanized国药准字H202239092022/11/30Generic 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

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.