YaoGeJu

Company directoryChina company filings

Jiu Hua Hua Yuan Pharma (Gui Lin) 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 8e87bdc7f7

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

11 acceptance records as first applicant, grouped into 8 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.

Olopatadine Hydrochloride Granules 1 records · Latest accepted 2026/04/04

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2600785Generic2026/04/04Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanizedCDE ↗
Mirogabalin Besilate Tablets 2 records · Latest accepted 2026/04/01

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2600759Generic2026/04/01Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.CDE ↗
CYHS2504041Generic2025/11/22Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.CDE ↗
Finerenone Tablets 2 records · Latest accepted 2026/02/13

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2600466Generic2026/02/13Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
CYHS2600464Generic2026/02/13Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
Trazodone Hydrochloride Sustained-release Tablets 1 records · Latest accepted 2025/12/27

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2504439Generic2025/12/27Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanizedCDE ↗
Upadacitinib Sustained-release Tablets 1 records · Latest accepted 2025/11/21

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2504028Generic2025/11/21Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.CDE ↗
瑞维那新吸入溶液 · No verified English name 1 records · Latest accepted 2025/08/28

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2503159Generic2025/08/28Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
Labetalol Hydrochloride Injection 2 records · Latest accepted 2025/03/18

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501090Generic2025/03/18Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.CDE ↗
CYHS2501089Generic2025/03/18Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.CDE ↗
Edaravone and Dexborneol Concentrated Solution for Injection 1 records · Latest accepted 2025/02/27

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2500855Generic2025/02/27Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.CDE ↗

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.

Marketing application approved: 1 application

  1. 2026/10/26Marketing application approved

    Labetalol Hydrochloride Injection

    CYHS2501090 · 国药准字H20266394

    Fact date: 2026/10/26 · Publication date: 2026/10/27 · Site observation date: 2026/11/03

    View source · Table row 38 ↗

Under review

8 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
Olopatadine Hydrochloride Granules CYHS2600785Generic2026/04/04Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanizedCDE ↗
Mirogabalin Besilate Tablets CYHS2600759Generic2026/04/01Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.CDE ↗
Finerenone Tablets CYHS2600466Generic2026/02/13Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
Finerenone Tablets CYHS2600464Generic2026/02/13Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
Trazodone Hydrochloride Sustained-release Tablets CYHS2504439Generic2025/12/27Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanizedCDE ↗
Mirogabalin Besilate Tablets CYHS2504041Generic2025/11/22Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.CDE ↗
Upadacitinib Sustained-release Tablets CYHS2504028Generic2025/11/21Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.CDE ↗
瑞维那新吸入溶液 · No verified English name CYHS2503159Generic2025/08/28Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗

Catalogue holder records

2 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
Edaravone and Dexborneol Concentrated Solution for InjectionJiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanizedGuangdong Sunho Pharmaceutical Co., Ltd.国药准字H202655372026/08/04Generic approved under the new chemical-drug registration classificationCDE ↗
Labetalol Hydrochloride InjectionJiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanizedGuangdong Sunho Pharmaceutical Co., Ltd.国药准字H202663942026/10/26Generic 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

2 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
小儿化痰止咳颗粒 · No verified English name CYZB2500915Supplement2025/05/12Jiu Hua Hua Yuan Pharma Co., Ltd. romanized; Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanizedCDE ↗
感冒灵胶囊 · No verified English name CYZB2500914Supplement2025/05/12Jiu Hua Hua Yuan Pharma Co., Ltd. romanized; Jiu Hua Hua Yuan Pharma (Gui Lin) 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.