Hefei He Yuan 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 17c509c2d6
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
21 acceptance records as first applicant, grouped into 14 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.
Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ) 2 records · Latest accepted 2026/11/04
Supplement · 1Generic · 1
达格列净二甲双胍缓释片(IV) · No verified English name 1 records · Latest accepted 2026/11/04
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2601997 | Supplement | 2026/11/04 | Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
Fexofenadine Hydrochloride Tablets 2 records · Latest accepted 2026/09/07
Generic · 2
Dapagliflozin and Saxagliptin Tablets 1 records · Latest accepted 2026/08/24
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHL2600089 | Generic | 2026/08/24 | Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
Candesartan Cilexetil and Hydrochlorothiazide Tablets(II) 1 records · Latest accepted 2026/06/26
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2601502 | Generic | 2026/06/26 | Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
Sacubitril Valsartan Sodium Tablets 2 records · Latest accepted 2026/06/22
Supplement · 1Generic · 1
Metoprolol Succinate Sustained-release Tablets 3 records · Latest accepted 2026/03/17
Supplement · 3
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2600525 | Supplement | 2026/03/17 | Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2201940 | Supplement | 2022/10/21 | Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2201939 | Supplement | 2022/10/21 | Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
Doxofylline Tablets 1 records · Latest accepted 2025/10/11
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2503631 | Generic | 2025/10/11 | Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets(III) 1 records · Latest accepted 2025/08/19
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2503028 | Generic | 2025/08/19 | Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
Dapagliflozin Tablets 2 records · Latest accepted 2025/06/04
Generic · 2
Diclofenac Sodium Sustained Release Tablets 2 records · Latest accepted 2025/04/24
Generic · 2
Saxagliptin and Metformin Hydrochloride Sustained-release Tablets 1 records · Latest accepted 2022/05/24
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2200738 | Generic | 2022/05/24 | Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
Saxagliptin and Metformin Hydrochloride Sustained-release Tablets 1 records · Latest accepted 2022/05/24
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2200739 | Generic | 2022/05/24 | Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
Saxagliptin Tablets 1 records · Latest accepted 2021/05/13
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2101149 | Generic | 2021/05/13 | Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
Changes in the last 90 days
7 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: 2 applicationsAccepted: 5 applications
- 2026/11/04Accepted
Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ)
CYHB2601998
Fact date: 2026/11/04 · Site observation date: 2026/11/05
View source ↗ - 2026/11/04Accepted
达格列净二甲双胍缓释片(IV) · No verified English name
CYHB2601997
Fact date: 2026/11/04 · Site observation date: 2026/11/05
View source ↗ - 2026/10/20Marketing application approved
Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets(III)
CYHS2503028 · 国药准字H20266338
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
View source · Table row 100 ↗ - 2026/10/20Marketing application approved
Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ)
CYHS2503027 · 国药准字H20266337
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
View source · Table row 99 ↗ - 2026/09/07Accepted
Fexofenadine Hydrochloride Tablets
CYHS2602222
Fact date: 2026/09/07 · Site observation date: 2026/10/22
View source ↗ - 2026/09/07Accepted
Fexofenadine Hydrochloride Tablets
CYHS2602220
Fact date: 2026/09/07 · Site observation date: 2026/10/22
View source ↗ - 2026/08/24Accepted
Dapagliflozin and Saxagliptin Tablets
CYHL2600089
Fact date: 2026/08/24 · 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.
| Drug | Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|---|
| Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ) | CYHB2601998 | Supplement | 2026/11/04 | Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
| 达格列净二甲双胍缓释片(IV) · No verified English name | CYHB2601997 | Supplement | 2026/11/04 | Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
| Fexofenadine Hydrochloride Tablets | CYHS2602222 | Generic | 2026/09/07 | Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
| Fexofenadine Hydrochloride Tablets | CYHS2602220 | Generic | 2026/09/07 | Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
| Candesartan Cilexetil and Hydrochlorothiazide Tablets(II) | CYHS2601502 | Generic | 2026/06/26 | Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
Catalogue holder records
20 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 |
|---|---|---|---|---|---|---|
| Dapagliflozin Tablets | Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20265802 | 2026/09/02 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Dapagliflozin Tablets | Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20265803 | 2026/09/02 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Diclofenac Sodium Sustained Release Tablets | Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20265435 | 2026/07/28 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Sacubitril Valsartan Sodium Tablets | Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20253014 | 2025/01/02 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Saxagliptin and Metformin Hydrochloride Sustained-release Tablets | Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20234334 | 2023/10/18 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Saxagliptin and Metformin Hydrochloride Sustained-release Tablets | Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20234335 | 2023/10/18 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Saxagliptin Tablets | Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20223775 | 2022/10/25 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Atomoxetine Hydrochloride Capsules | Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20223482 | 2022/07/07 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Valsartan and Amlodipine Tablets(I) | Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20223085 | 2022/02/23 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Atomoxetine Hydrochloride Capsules | Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20213814 | 2021/10/26 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Topiramate Tablets | Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20213669 | 2021/08/25 | Not stated by source | CDE ↗ |
| Topiramate Tablets | Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20213668 | 2021/08/25 | Not stated by source | CDE ↗ |
| Metoprolol Succinate Sustained-release Tablets | Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20213593 | 2021/07/20 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Metoprolol Succinate Sustained-release Tablets | Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20213592 | 2021/07/20 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Indapamide Prolonged-release Tablets | Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20213537 | 2021/06/22 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Isosorbide Mononitrate Sustained-release Capsules | Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20203673 | 2020/12/11 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Memantine Hydrochloride Tablets | Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20203555 | 2020/11/04 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Rosuvastatin Calcium Tablets | Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20203395 | 2020/08/05 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Rosuvastatin Calcium Tablets | Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20203396 | 2020/08/05 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Diclofenac Sodium Sustained Release Tablets | Hefei He Yuan Pharma Co., Ltd. romanized | Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H20265436 | 2026/07/28 | 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
9 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 |
|---|---|---|---|---|---|
| 沙库巴曲缬沙坦钠 · No verified English name | Hefei He Yuan Pharma Co., Ltd. romanized | Y20230000750 | A | 2025/01/13 | CDE ↗ |
| 沙格列汀 · No verified English name | Hefei He Yuan Pharma Co., Ltd. romanized | Y20210000452 | A | 2022/11/10 | CDE ↗ |
| 托吡酯 · No verified English name | Hefei He Yuan Pharma Co., Ltd. romanized | Y20190021234 | A | 2025/12/10 | CDE ↗ |
| HYR-PB21 · No verified English name | Hefei He Yuan Pharma Co., Ltd. romanized | Y20200000088 | I | 2022/09/15 | CDE ↗ |
| 盐酸美金刚 · No verified English name | Hefei He Yuan Pharma Co., Ltd. romanized | Y20190000706 | A | 2025/06/25 | CDE ↗ |
| 盐酸托莫西汀 · No verified English name | Hefei He Yuan Pharma Co., Ltd. romanized | Y20170001280 | A | 2023/11/30 | CDE ↗ |
| 氢溴酸加兰他敏 · No verified English name | Hefei He Yuan Pharma Co., Ltd. romanized | Y20170001208 | A | 2023/12/22 | CDE ↗ |
| 泛硫乙胺 · No verified English name | Hefei He Yuan Pharma Co., Ltd. romanized | Y20170001040 | A | 2026/10/14 | CDE ↗ |
| 盐酸可乐定 · No verified English name | Hefei He Yuan Pharma Co., Ltd. romanized | Y20170001034 | A | 2024/01/05 | 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
10 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 |
|---|---|---|---|---|---|
| Saxagliptin and Metformin Hydrochloride Sustained-release Tablets | CYHB2400349 | Supplement | 2024/03/07 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
| Saxagliptin and Metformin Hydrochloride Sustained-release Tablets | CYHB2400348 | Supplement | 2024/03/07 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
| Atomoxetine Hydrochloride Capsules | CYHB2301789 | Supplement | 2023/08/15 | Beijing Jin Sai Zeng Medical Technology Co., Ltd. romanized; Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
| Atomoxetine Hydrochloride Capsules | CYHB2301788 | Supplement | 2023/08/15 | Beijing Jin Sai Zeng Medical Technology Co., Ltd. romanized; Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
| Saxagliptin Tablets | CYHB2300351 | Supplement | 2023/02/21 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
| Valsartan and Amlodipine Tablets(I) | CYHB2300051 | Supplement | 2023/01/07 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
| Rosuvastatin Calcium Tablets | CYHB2300050 | Supplement | 2023/01/07 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
| Rosuvastatin Calcium Tablets | CYHB2300049 | Supplement | 2023/01/07 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
| Topiramate Tablets | CYHB2201740 | Supplement | 2022/09/22 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Hefei He Yuan Pharma Co., Ltd. romanized | CDE ↗ |
| Topiramate Tablets | CYHB2201739 | Supplement | 2022/09/22 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Hefei He Yuan Pharma 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.