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
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
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2600785 | Generic | 2026/04/04 | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Mirogabalin Besilate Tablets 2 records · Latest accepted 2026/04/01
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2600759 | Generic | 2026/04/01 | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. | CDE ↗ |
| CYHS2504041 | Generic | 2025/11/22 | Jiu 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
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2600466 | Generic | 2026/02/13 | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CDE ↗ |
| CYHS2600464 | Generic | 2026/02/13 | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CDE ↗ |
Trazodone Hydrochloride Sustained-release Tablets 1 records · Latest accepted 2025/12/27
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2504439 | Generic | 2025/12/27 | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized | CDE ↗ |
Upadacitinib Sustained-release Tablets 1 records · Latest accepted 2025/11/21
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2504028 | Generic | 2025/11/21 | Jiu 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
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2503159 | Generic | 2025/08/28 | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Labetalol Hydrochloride Injection 2 records · Latest accepted 2025/03/18
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2501090 | Generic | 2025/03/18 | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. | CDE ↗ |
| CYHS2501089 | Generic | 2025/03/18 | Jiu 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
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2500855 | Generic | 2025/02/27 | Jiu 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
- 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.
| Drug | Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|---|
| Olopatadine Hydrochloride Granules | CYHS2600785 | Generic | 2026/04/04 | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Mirogabalin Besilate Tablets | CYHS2600759 | Generic | 2026/04/01 | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. | CDE ↗ |
| Finerenone Tablets | CYHS2600466 | Generic | 2026/02/13 | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CDE ↗ |
| Finerenone Tablets | CYHS2600464 | Generic | 2026/02/13 | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CDE ↗ |
| Trazodone Hydrochloride Sustained-release Tablets | CYHS2504439 | Generic | 2025/12/27 | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized | CDE ↗ |
| Mirogabalin Besilate Tablets | CYHS2504041 | Generic | 2025/11/22 | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. | CDE ↗ |
| Upadacitinib Sustained-release Tablets | CYHS2504028 | Generic | 2025/11/21 | Jiu 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 | CYHS2503159 | Generic | 2025/08/28 | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CDE ↗ |
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.
| Drug | Marketing authorization holder | Manufacturer | Approval number | Approved | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Edaravone and Dexborneol Concentrated Solution for Injection | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized | Guangdong Sunho Pharmaceutical Co., Ltd. | 国药准字H20265537 | 2026/08/04 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Labetalol Hydrochloride Injection | Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized | Guangdong Sunho Pharmaceutical Co., Ltd. | 国药准字H20266394 | 2026/10/26 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
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.
| Name | Company / applicant | Registration number | Status | Source update date | View 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.
| Drug | Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|---|
| 小儿化痰止咳颗粒 · No verified English name | CYZB2500915 | Supplement | 2025/05/12 | Jiu Hua Hua Yuan Pharma Co., Ltd. romanized; Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized | CDE ↗ |
| 感冒灵胶囊 · No verified English name | CYZB2500914 | Supplement | 2025/05/12 | Jiu Hua Hua Yuan Pharma Co., Ltd. romanized; Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized | CDE ↗ |
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.