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Company directoryChina company filings

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

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

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

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2601998Supplement2026/11/04Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
CYHS2503027Generic2025/08/19Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
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

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2601997Supplement2026/11/04Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Fexofenadine Hydrochloride Tablets 2 records · Latest accepted 2026/09/07

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2602222Generic2026/09/07Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
CYHS2602220Generic2026/09/07Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Dapagliflozin and Saxagliptin Tablets 1 records · Latest accepted 2026/08/24

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHL2600089Generic2026/08/24Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Candesartan Cilexetil and Hydrochlorothiazide Tablets(II) 1 records · Latest accepted 2026/06/26

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2601502Generic2026/06/26Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Sacubitril Valsartan Sodium Tablets 2 records · Latest accepted 2026/06/22

Supplement · 1Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2601158Supplement2026/06/22Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
CYHS2302619Generic2023/09/28Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Metoprolol Succinate Sustained-release Tablets 3 records · Latest accepted 2026/03/17

Supplement · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2600525Supplement2026/03/17Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
CYHB2201940Supplement2022/10/21Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
CYHB2201939Supplement2022/10/21Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Doxofylline Tablets 1 records · Latest accepted 2025/10/11

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2503631Generic2025/10/11Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets(III) 1 records · Latest accepted 2025/08/19

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2503028Generic2025/08/19Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Dapagliflozin Tablets 2 records · Latest accepted 2025/06/04

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501978Generic2025/06/04Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
CYHS2501977Generic2025/06/04Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Diclofenac Sodium Sustained Release Tablets 2 records · Latest accepted 2025/04/24

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501552Generic2025/04/24Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
CYHS2501551Generic2025/04/24Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Saxagliptin and Metformin Hydrochloride Sustained-release Tablets 1 records · Latest accepted 2022/05/24

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2200738Generic2022/05/24Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Saxagliptin and Metformin Hydrochloride Sustained-release Tablets 1 records · Latest accepted 2022/05/24

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2200739Generic2022/05/24Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Saxagliptin Tablets 1 records · Latest accepted 2021/05/13

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2101149Generic2021/05/13Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗

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

  1. 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 ↗
  2. 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 ↗
  3. 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 ↗
  4. 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 ↗
  5. 2026/09/07Accepted

    Fexofenadine Hydrochloride Tablets

    CYHS2602222

    Fact date: 2026/09/07 · Site observation date: 2026/10/22

    View source ↗
  6. 2026/09/07Accepted

    Fexofenadine Hydrochloride Tablets

    CYHS2602220

    Fact date: 2026/09/07 · Site observation date: 2026/10/22

    View source ↗
  7. 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.

Under review
Drug Acceptance numberApplication typeAcceptedCompany / applicantView source
Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ) CYHB2601998Supplement2026/11/04Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
达格列净二甲双胍缓释片(IV) · No verified English name CYHB2601997Supplement2026/11/04Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Fexofenadine Hydrochloride Tablets CYHS2602222Generic2026/09/07Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Fexofenadine Hydrochloride Tablets CYHS2602220Generic2026/09/07Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Candesartan Cilexetil and Hydrochlorothiazide Tablets(II) CYHS2601502Generic2026/06/26Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗

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.

DrugMarketing authorization holderManufacturerApproval numberApprovedCatalogue category (source text)View source
Dapagliflozin TabletsHefei He Yuan Pharma Co., Ltd. romanizedHefei He Yuan Pharma Co., Ltd. romanized国药准字H202658022026/09/02Generic approved under the new chemical-drug registration classificationCDE ↗
Dapagliflozin TabletsHefei He Yuan Pharma Co., Ltd. romanizedHefei He Yuan Pharma Co., Ltd. romanized国药准字H202658032026/09/02Generic approved under the new chemical-drug registration classificationCDE ↗
Diclofenac Sodium Sustained Release TabletsHefei He Yuan Pharma Co., Ltd. romanizedHefei He Yuan Pharma Co., Ltd. romanized国药准字H202654352026/07/28Generic approved under the new chemical-drug registration classificationCDE ↗
Sacubitril Valsartan Sodium TabletsHefei He Yuan Pharma Co., Ltd. romanizedHefei He Yuan Pharma Co., Ltd. romanized国药准字H202530142025/01/02Generic approved under the new chemical-drug registration classificationCDE ↗
Saxagliptin and Metformin Hydrochloride Sustained-release TabletsHefei He Yuan Pharma Co., Ltd. romanizedHefei He Yuan Pharma Co., Ltd. romanized国药准字H202343342023/10/18Generic approved under the new chemical-drug registration classificationCDE ↗
Saxagliptin and Metformin Hydrochloride Sustained-release TabletsHefei He Yuan Pharma Co., Ltd. romanizedHefei He Yuan Pharma Co., Ltd. romanized国药准字H202343352023/10/18Generic approved under the new chemical-drug registration classificationCDE ↗
Saxagliptin TabletsHefei He Yuan Pharma Co., Ltd. romanizedHefei He Yuan Pharma Co., Ltd. romanized国药准字H202237752022/10/25Generic approved under the new chemical-drug registration classificationCDE ↗
Atomoxetine Hydrochloride CapsulesHefei He Yuan Pharma Co., Ltd. romanizedHefei He Yuan Pharma Co., Ltd. romanized国药准字H202234822022/07/07Generic approved under the new chemical-drug registration classificationCDE ↗
Valsartan and Amlodipine Tablets(I)Hefei He Yuan Pharma Co., Ltd. romanizedHefei He Yuan Pharma Co., Ltd. romanized国药准字H202230852022/02/23Generic approved under the new chemical-drug registration classificationCDE ↗
Atomoxetine Hydrochloride CapsulesHefei He Yuan Pharma Co., Ltd. romanizedHefei He Yuan Pharma Co., Ltd. romanized国药准字H202138142021/10/26Generic approved under the new chemical-drug registration classificationCDE ↗
Topiramate TabletsHefei He Yuan Pharma Co., Ltd. romanizedHefei He Yuan Pharma Co., Ltd. romanized国药准字H202136692021/08/25Not stated by sourceCDE ↗
Topiramate TabletsHefei He Yuan Pharma Co., Ltd. romanizedHefei He Yuan Pharma Co., Ltd. romanized国药准字H202136682021/08/25Not stated by sourceCDE ↗
Metoprolol Succinate Sustained-release TabletsHefei He Yuan Pharma Co., Ltd. romanizedHefei He Yuan Pharma Co., Ltd. romanized国药准字H202135932021/07/20Generic approved under the new chemical-drug registration classificationCDE ↗
Metoprolol Succinate Sustained-release TabletsHefei He Yuan Pharma Co., Ltd. romanizedHefei He Yuan Pharma Co., Ltd. romanized国药准字H202135922021/07/20Generic approved under the new chemical-drug registration classificationCDE ↗
Indapamide Prolonged-release TabletsHefei He Yuan Pharma Co., Ltd. romanizedHefei He Yuan Pharma Co., Ltd. romanized国药准字H202135372021/06/22Generic approved under the new chemical-drug registration classificationCDE ↗
Isosorbide Mononitrate Sustained-release CapsulesHefei He Yuan Pharma Co., Ltd. romanizedHefei He Yuan Pharma Co., Ltd. romanized国药准字H202036732020/12/11Generic approved under the new chemical-drug registration classificationCDE ↗
Memantine Hydrochloride TabletsHefei He Yuan Pharma Co., Ltd. romanizedHefei He Yuan Pharma Co., Ltd. romanized国药准字H202035552020/11/04Generic approved under the new chemical-drug registration classificationCDE ↗
Rosuvastatin Calcium TabletsHefei He Yuan Pharma Co., Ltd. romanizedHefei He Yuan Pharma Co., Ltd. romanized国药准字H202033952020/08/05Generic approved under the new chemical-drug registration classificationCDE ↗
Rosuvastatin Calcium TabletsHefei He Yuan Pharma Co., Ltd. romanizedHefei He Yuan Pharma Co., Ltd. romanized国药准字H202033962020/08/05Generic approved under the new chemical-drug registration classificationCDE ↗
Diclofenac Sodium Sustained Release TabletsHefei He Yuan Pharma Co., Ltd. romanizedHefei He Yuan Pharma Co., Ltd. romanized国药准字H202654362026/07/28Generic 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

9 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
沙库巴曲缬沙坦钠 · No verified English nameHefei He Yuan Pharma Co., Ltd. romanizedY20230000750A2025/01/13CDE ↗
沙格列汀 · No verified English nameHefei He Yuan Pharma Co., Ltd. romanizedY20210000452A2022/11/10CDE ↗
托吡酯 · No verified English nameHefei He Yuan Pharma Co., Ltd. romanizedY20190021234A2025/12/10CDE ↗
HYR-PB21 · No verified English nameHefei He Yuan Pharma Co., Ltd. romanizedY20200000088I2022/09/15CDE ↗
盐酸美金刚 · No verified English nameHefei He Yuan Pharma Co., Ltd. romanizedY20190000706A2025/06/25CDE ↗
盐酸托莫西汀 · No verified English nameHefei He Yuan Pharma Co., Ltd. romanizedY20170001280A2023/11/30CDE ↗
氢溴酸加兰他敏 · No verified English nameHefei He Yuan Pharma Co., Ltd. romanizedY20170001208A2023/12/22CDE ↗
泛硫乙胺 · No verified English nameHefei He Yuan Pharma Co., Ltd. romanizedY20170001040A2026/10/14CDE ↗
盐酸可乐定 · No verified English nameHefei He Yuan Pharma Co., Ltd. romanizedY20170001034A2024/01/05CDE ↗

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.

Co-applicant records
Drug Acceptance numberApplication typeAcceptedCompany / applicantView source
Saxagliptin and Metformin Hydrochloride Sustained-release Tablets CYHB2400349Supplement2024/03/07Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Saxagliptin and Metformin Hydrochloride Sustained-release Tablets CYHB2400348Supplement2024/03/07Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Atomoxetine Hydrochloride Capsules CYHB2301789Supplement2023/08/15Beijing Jin Sai Zeng Medical Technology Co., Ltd. romanized; Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Atomoxetine Hydrochloride Capsules CYHB2301788Supplement2023/08/15Beijing Jin Sai Zeng Medical Technology Co., Ltd. romanized; Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Saxagliptin Tablets CYHB2300351Supplement2023/02/21Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Valsartan and Amlodipine Tablets(I) CYHB2300051Supplement2023/01/07Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Rosuvastatin Calcium Tablets CYHB2300050Supplement2023/01/07Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Rosuvastatin Calcium Tablets CYHB2300049Supplement2023/01/07Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Topiramate Tablets CYHB2201740Supplement2022/09/22Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Hefei He Yuan Pharma Co., Ltd. romanizedCDE ↗
Topiramate Tablets CYHB2201739Supplement2022/09/22Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Hefei He Yuan Pharma 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.