Gui Lin Hua Xin Pharmaceutical 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 d4c21a8cfa
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
25 acceptance records as first applicant, grouped into 16 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.
Emedastine Difumarate Sustained-release Capsules 2 records · Latest accepted 2026/06/18
Generic · 2
腺苷钴胺胶囊 · No verified English name 2 records · Latest accepted 2026/06/10
Supplement · 1Generic · 1
Esomeprazole Magnesium Enteric-Coated Capsules 2 records · Latest accepted 2026/04/22
Generic · 2
Fexofenadine Hydrochloride Oral Suspension 1 records · Latest accepted 2026/02/27
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2600563 | Generic | 2026/02/27 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Benidipine Hydrochloride Tablets 1 records · Latest accepted 2025/10/17
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2503722 | Generic | 2025/10/17 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Candesartan Cilexetil and Hydrochlorothiazide Tablets 1 records · Latest accepted 2025/04/30
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2501617 | Generic | 2025/04/30 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Lansoprazole Enteric Capsules 2 records · Latest accepted 2025/03/14
Supplement · 1Generic · 1
盐酸非索非那定干混悬剂 · No verified English name 2 records · Latest accepted 2025/01/15
Generic · 2
Perindopril Arginine and Amlodipine Besylate Tablets(III) 1 records · Latest accepted 2024/09/25
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2403160 | Generic | 2024/09/25 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Terbinafine Hydrochloride Cream 1 records · Latest accepted 2024/09/13
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2401458 | Supplement | 2024/09/13 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Metoprolol Succinate Extended-release Capsules 2 records · Latest accepted 2024/08/08
Generic · 2
Acetylcysteine Granules 4 records · Latest accepted 2023/07/12
Supplement · 3Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2301557 | Supplement | 2023/07/12 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2301317 | Supplement | 2023/06/12 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2300306 | Supplement | 2023/02/16 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2101420 | Generic | 2021/07/08 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CDE ↗ |
磷霉素氨丁三醇颗粒 · No verified English name 1 records · Latest accepted 2023/04/27
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2301185 | Generic | 2023/04/27 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Fluvoxamine Maleate Tablets 1 records · Latest accepted 2022/09/29
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2201633 | Generic | 2022/09/29 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Omeprazole Enteric Capsules 1 records · Latest accepted 2021/07/16
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2150739 | Supplement | 2021/07/16 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Valsartan Capsules 1 records · Latest accepted 2021/02/22
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2100218 | Generic | 2021/02/22 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | 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.
No longer listed under review: 1 application
- 2026/10/29No longer listed under review
Candesartan Cilexetil and Hydrochlorothiazide Tablets
CYHS2501617
Fact date: 2026/10/29 · Site observation date: 2026/10/29
Accepted: 2025/04/30
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗
Under review
7 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 |
|---|---|---|---|---|---|
| Emedastine Difumarate Sustained-release Capsules | CYHS2601452 | Generic | 2026/06/18 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Emedastine Difumarate Sustained-release Capsules | CYHS2601451 | Generic | 2026/06/18 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| 腺苷钴胺胶囊 · No verified English name | CYHB2601084 | Supplement | 2026/06/10 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Esomeprazole Magnesium Enteric-Coated Capsules | CYHS2600920 | Generic | 2026/04/22 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Esomeprazole Magnesium Enteric-Coated Capsules | CYHS2600919 | Generic | 2026/04/22 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Fexofenadine Hydrochloride Oral Suspension | CYHS2600563 | Generic | 2026/02/27 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Benidipine Hydrochloride Tablets | CYHS2503722 | Generic | 2025/10/17 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Catalogue holder records
10 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 |
|---|---|---|---|---|---|---|
| Perindopril Arginine and Amlodipine Besylate Tablets(III) | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20263348 | 2026/02/02 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Metoprolol Succinate Extended-release Capsules | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20256269 | 2025/12/16 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Metoprolol Succinate Extended-release Capsules | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20256270 | 2025/12/16 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| 腺苷钴胺胶囊 · No verified English name | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20255185 | 2025/08/26 | Other drug | CDE ↗ |
| Lansoprazole Enteric Capsules | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20244909 | 2024/09/19 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Fluvoxamine Maleate Tablets | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20243538 | 2024/04/17 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Acetylcysteine Granules | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20223842 | 2022/11/15 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Omeprazole Enteric Capsules | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20143204 | 2022/06/21 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Valsartan Capsules | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20223240 | 2022/04/19 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Venlafaxine Hydrochloride Sustained-Release Capsules | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20223035 | 2022/01/30 | 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
17 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 |
|---|---|---|---|---|---|
| 右兰索拉唑 · No verified English name | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Y20260000845 | I | 2026/10/21 | CDE ↗ |
| 盐酸贝尼地平 · No verified English name | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Y20250001017 | I | 2025/09/24 | CDE ↗ |
| 雷贝拉唑钠 · No verified English name | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Y20240000625 | A | 2025/12/18 | CDE ↗ |
| 琥珀酸美托洛尔 · No verified English name | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Y20230000348 | A | 2026/03/12 | CDE ↗ |
| 艾司奥美拉唑镁 · No verified English name | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Y20200001423 | A | 2026/06/02 | CDE ↗ |
| 盐酸文拉法辛 · No verified English name | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Y20190009845 | A | 2024/08/23 | CDE ↗ |
| 奥美拉唑钠 · No verified English name | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Y20190009696 | A | 2024/09/27 | CDE ↗ |
| 兰索拉唑 · No verified English name | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Y20190008644 | A | 2024/09/21 | CDE ↗ |
| 奥美拉唑 · No verified English name | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Y20190008084 | A | 2024/09/21 | CDE ↗ |
| 泮托拉唑钠 · No verified English name | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Y20190006133 | A | 2024/09/21 | CDE ↗ |
| 酮康唑 · No verified English name | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Y20190006132 | A | 2025/01/01 | CDE ↗ |
| 磷霉素氨丁三醇 · No verified English name | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Y20190005284 | A | 2024/09/21 | CDE ↗ |
| 胶体果胶铋 · No verified English name | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Y20190001385 | A | 2025/01/01 | CDE ↗ |
| 奥美拉唑钠 · No verified English name | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Y20190000169 | I | 2019/04/01 | CDE ↗ |
| 兰索拉唑 · No verified English name | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Y20180001274 | A | 2025/12/31 | CDE ↗ |
| 盐酸文拉法辛 · No verified English name | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Y20180000005 | I | 2019/01/14 | CDE ↗ |
| 马来酸氟伏沙明 · No verified English name | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Y20170001375 | A | 2026/06/02 | CDE ↗ |
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.
| Drug | Acceptance number | Application type | Accepted | Company / applicant | View 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.