Kui Hua Pharma Group (Heng Shui) De Fei Er 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 a55b4a86c3
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
6 acceptance records as first applicant, grouped into 4 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.
Mesalazine Gastro-Resistant Prolonged-Release Granules 2 records · Latest accepted 2026/07/06
Supplement · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2601273 | Supplement | 2026/07/06 | Kui Hua Pharma Group (Heng Shui) De Fei Er Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2601272 | Supplement | 2026/07/06 | Kui Hua Pharma Group (Heng Shui) De Fei Er Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized | CDE ↗ |
Glucosamine Sulfate Capsules 1 records · Latest accepted 2026/05/19
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2600965 | Supplement | 2026/05/19 | Kui Hua Pharma Group (Heng Shui) De Fei Er Co., Ltd. romanized; Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Oseltamivir Phosphate For Oral Suspension 2 records · Latest accepted 2023/10/21
Generic · 2
阿莫西林颗粒 · No verified English name 1 records · Latest accepted 2021/07/02
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2150706 | Supplement | 2021/07/02 | Kui Hua Pharma Group (Heng Shui) De Fei Er Co., Ltd. romanized | CDE ↗ |
Changes in the last 90 days
4 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 applicationsSupplement delivery: 2 applications
- 2026/10/20Supplement delivery
Mesalazine Gastro-Resistant Prolonged-Release Granules
CYHB2601273 · 国药准字H20266317
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 54 ↗ - 2026/10/20Supplement delivery
Mesalazine Gastro-Resistant Prolonged-Release Granules
CYHB2601272 · 国药准字H20266316
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 53 ↗ - 2026/10/20Marketing application approved
Mesalazine Gastro-Resistant Prolonged-Release Granules
CYHS2501527 · 国药准字H20266317
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
View source · Table row 54 ↗ - 2026/10/20Marketing application approved
Mesalazine Gastro-Resistant Prolonged-Release Granules
CYHS2501526 · 国药准字H20266316
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
View source · Table row 53 ↗
Under review
0 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 |
|---|---|---|---|---|---|
| No matching records were found in the currently loaded source data; coverage dates are listed below. | |||||
Catalogue holder records
3 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 |
|---|---|---|---|---|---|---|
| Oseltamivir Phosphate For Oral Suspension | Kui Hua Pharma Group (Heng Shui) De Fei Er Co., Ltd. romanized | Kui Hua Pharma Group (Heng Shui) De Fei Er Co., Ltd. romanized | 国药准字H20253868 | 2025/04/15 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| 阿莫西林颗粒 · No verified English name | Kui Hua Pharma Group (Heng Shui) De Fei Er Co., Ltd. romanized | Kui Hua Pharma Group (Heng Shui) De Fei Er Co., Ltd. romanized | 国药准字H13024272 | 2023/03/22 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Glucosamine Sulfate Capsules | Kui Hua Pharma Group (Heng Shui) De Fei Er Co., Ltd. romanized | Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized | 国药准字H20265656 | 2026/08/18 | 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
1 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 |
|---|---|---|---|---|---|
| Oseltamivir Phosphate For Oral Suspension | CYHB2502417 | Supplement | 2025/11/27 | Guangzhou Ai Ge Bio Technology Co., Ltd. romanized; Kui Hua Pharma Group (Heng Shui) De Fei Er 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.