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Hunan Hui Ze Biopharmaceuticals Technology 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 daa1a306cc

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

34 acceptance records as first applicant, grouped into 20 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.

HXASP028 · No verified English name 2 records · Latest accepted 2026/11/04

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CXHB2600472Supplement2026/11/04Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedCDE ↗
CXHB2600471Supplement2026/11/04Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedCDE ↗
HXLMT026 · No verified English name 3 records · Latest accepted 2026/08/14

Supplement · 1New drug · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CXHB2600304Supplement2026/08/14Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedCDE ↗
CXHL2500937New drug2025/09/02Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedCDE ↗
CXHL2500203New drug2025/02/18Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedCDE ↗
醋酸阿比特龙软胶囊 · No verified English name 4 records · Latest accepted 2026/08/05

Supplement · 2New drug · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CXHB2600283Supplement2026/08/05Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanizedCDE ↗
CXHB2600282Supplement2026/08/05Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanizedCDE ↗
CXHL2200405New drug2022/06/22Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedCDE ↗
CXHL2200404New drug2022/06/22Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedCDE ↗
Methotrexate Tablets 1 records · Latest accepted 2026/06/17

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2601436Generic2026/06/17Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hainan Ri Zhong Tian Pharmaceutical Co., Ltd. romanizedCDE ↗
二甲双胍恩格列净片(I) · No verified English name 3 records · Latest accepted 2026/01/20

Supplement · 2Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2600104Supplement2026/01/20Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
CYHB2401760Supplement2024/10/31Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
CYHS2301030Generic2023/04/12Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
二甲双胍恩格列净片(V) · No verified English name 2 records · Latest accepted 2026/01/20

Supplement · 1Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2600105Supplement2026/01/20Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
CYHS2301031Generic2023/04/12Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
二甲双胍恩格列净片(VI) · No verified English name 2 records · Latest accepted 2026/01/20

Supplement · 1Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2600106Supplement2026/01/20Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
CYHS2301032Generic2023/04/12Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
磷酸奥司他韦颗粒 · No verified English name 1 records · Latest accepted 2025/02/25

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2500375Supplement2025/02/25Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jia Heng Pharmaceutical Co., Ltd. romanizedCDE ↗
Finerenone Tablets 1 records · Latest accepted 2024/12/26

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2404544Generic2024/12/26Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
HXHTT024 · No verified English name 1 records · Latest accepted 2024/11/08

New drug · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CXHL2401203New drug2024/11/08Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedCDE ↗
Azilsartan Medoxomil Potassium Tablets 2 records · Latest accepted 2024/09/11

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2403022Generic2024/09/11Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
CYHS2403021Generic2024/09/11Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
Mesalazine Enteric-coated Tablets 1 records · Latest accepted 2024/03/26

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400912Generic2024/03/26Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
Telmisartan And Amlodipine Tablets 1 records · Latest accepted 2024/02/03

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400458Generic2024/02/03Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.CDE ↗
替米沙坦氨氯地平片(II) · No verified English name 1 records · Latest accepted 2024/02/03

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400459Generic2024/02/03Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.CDE ↗
Drotaverine Hydrochloride Injection 1 records · Latest accepted 2024/01/12

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400191Generic2024/01/12Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanizedCDE ↗
Irbesartan and Amlodipine Tablets 4 records · Latest accepted 2024/01/09

Generic · 4

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400113Generic2024/01/09Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
CYHS2400112Generic2024/01/09Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
CYHL2200045Generic2022/05/27Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedCDE ↗
CYHL2200044Generic2022/05/27Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedCDE ↗
Bisoprolol Fumarate and Amlodipine Besylate Tablets 1 records · Latest accepted 2023/11/21

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2303182Generic2023/11/21Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
Methotrexate Injection 1 records · Latest accepted 2023/08/30

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2302316Generic2023/08/30Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., LtdCDE ↗
帕拉米韦氯化钠注射液 · No verified English name 1 records · Latest accepted 2023/01/12

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2300121Generic2023/01/12Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
Calcium Gluconate Injection 1 records · Latest accepted 2022/07/26

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2201138Generic2022/07/26Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗

Changes in the last 90 days

2 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.

Accepted: 2 applications

  1. 2026/11/04Accepted

    HXASP028 · No verified English name

    CXHB2600472

    Fact date: 2026/11/04 · Site observation date: 2026/11/05

    View source ↗
  2. 2026/11/04Accepted

    HXASP028 · No verified English name

    CXHB2600471

    Fact date: 2026/11/04 · Site observation date: 2026/11/05

    View source ↗

Under review

6 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
HXASP028 · No verified English name CXHB2600472Supplement2026/11/04Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedCDE ↗
HXASP028 · No verified English name CXHB2600471Supplement2026/11/04Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedCDE ↗
Methotrexate Tablets CYHS2601436Generic2026/06/17Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hainan Ri Zhong Tian Pharmaceutical Co., Ltd. romanizedCDE ↗
二甲双胍恩格列净片(VI) · No verified English name CYHB2600106Supplement2026/01/20Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
二甲双胍恩格列净片(I) · No verified English name CYHB2600104Supplement2026/01/20Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
Bisoprolol Fumarate and Amlodipine Besylate Tablets CYHS2303182Generic2023/11/21Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗

Catalogue holder records

12 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
Finerenone TabletsHunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedHunan Jiudian Pharmaceutical Co., Ltd国药准字H202636962026/03/25Generic approved under the new chemical-drug registration classificationCDE ↗
Azilsartan Medoxomil Potassium TabletsHunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedHunan Jiudian Pharmaceutical Co., Ltd国药准字H202559812025/11/18Generic approved under the new chemical-drug registration classificationCDE ↗
Azilsartan Medoxomil Potassium TabletsHunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedHunan Jiudian Pharmaceutical Co., Ltd国药准字H202559822025/11/18Generic approved under the new chemical-drug registration classificationCDE ↗
二甲双胍恩格列净片(I) · No verified English nameHunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedHunan Jiudian Pharmaceutical Co., Ltd国药准字H202581492025/08/04Generic approved under the new chemical-drug registration classificationCDE ↗
替米沙坦氨氯地平片(II) · No verified English nameHunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedSichuan Kelun Pharmaceutical Co., Ltd.国药准字H202548742025/07/15Not stated by sourceCDE ↗
磷酸奥司他韦颗粒 · No verified English nameHunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedHunan Jia Heng Pharmaceutical Co., Ltd. romanized国药准字H202548482025/07/15Generic approved under the new chemical-drug registration classificationCDE ↗
Telmisartan And Amlodipine TabletsHunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedSichuan Kelun Pharmaceutical Co., Ltd.国药准字H202546412025/06/24Generic approved under the new chemical-drug registration classificationCDE ↗
Drotaverine Hydrochloride InjectionHunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedKang Pu Pharma Co., Ltd. romanized国药准字H202540302025/04/30Generic approved under the new chemical-drug registration classificationCDE ↗
Methotrexate InjectionHunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedHangzhou Minsheng Pharmaceutical Co., Ltd国药准字H202532562025/01/24Generic approved under the new chemical-drug registration classificationCDE ↗
二甲双胍恩格列净片(V) · No verified English nameHunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedHunan Jiudian Pharmaceutical Co., Ltd国药准字H202490312024/10/09Generic approved under the new chemical-drug registration classificationCDE ↗
二甲双胍恩格列净片(VI) · No verified English nameHunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedHunan Jiudian Pharmaceutical Co., Ltd国药准字H202490322024/10/09Generic approved under the new chemical-drug registration classificationCDE ↗
Peramivir InjectionHunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedHunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H202441502024/06/25Generic 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.