Zhi He (Shandong) Da Pharmaceutical Factory 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 9752bcd8ff
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 20 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.
Mannitol-S Injection 1 records · Latest accepted 2026/11/05
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2602013 | Supplement | 2026/11/05 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Foscarnet Sodium Injection 1 records · Latest accepted 2026/09/08
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2601701 | Supplement | 2026/09/08 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized | CDE ↗ |
磷酸二氢钠磷酸氢二钠颗粒 · No verified English name 1 records · Latest accepted 2026/08/20
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2602070 | Generic | 2026/08/20 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CDE ↗ |
Sodium Thiosulfate Injection 1 records · Latest accepted 2025/07/15
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2502527 | Generic | 2025/07/15 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
Bromhexine Hydrochloride Oral Solution 1 records · Latest accepted 2025/07/09
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2501348 | Supplement | 2025/07/09 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
盐酸甲氧氯普胺口服溶液 · No verified English name 1 records · Latest accepted 2025/04/22
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2501512 | Generic | 2025/04/22 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
Ebastine Oral Solution 1 records · Latest accepted 2025/03/18
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2500548 | Supplement | 2025/03/18 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
Terlipressin for Injection 1 records · Latest accepted 2025/03/18
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2500545 | Supplement | 2025/03/18 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
盐酸丙卡特罗吸入溶液 · No verified English name 1 records · Latest accepted 2025/03/18
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2500544 | Supplement | 2025/03/18 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
Alendronate Sodium Oral Solution 1 records · Latest accepted 2025/03/18
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2500547 | Supplement | 2025/03/18 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
Potassium Phosphates Injection 1 records · Latest accepted 2025/03/17
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2500540 | Supplement | 2025/03/17 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
Tobramycin Eye Drops 1 records · Latest accepted 2025/03/17
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2500542 | Supplement | 2025/03/17 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
Pranoprofen Eye Drops 1 records · Latest accepted 2025/03/17
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2500543 | Supplement | 2025/03/17 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
Potassium Aspartate Injection 1 records · Latest accepted 2025/03/17
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2500541 | Supplement | 2025/03/17 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
Polyvinyl Alcohol Eye Drops 1 records · Latest accepted 2024/10/01
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2403330 | Generic | 2024/10/01 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
西甲硅油乳剂 · No verified English name 1 records · Latest accepted 2023/02/08
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2300397 | Generic | 2023/02/08 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CDE ↗ |
Levofloxacin Injection 1 records · Latest accepted 2022/10/10
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2201838 | Supplement | 2022/10/10 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | CDE ↗ |
Lornoxicam for Injection 1 records · Latest accepted 2022/09/02
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2201438 | Generic | 2022/09/02 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized | CDE ↗ |
Tranexamic Acid Injection 1 records · Latest accepted 2021/09/18
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2101760 | Generic | 2021/09/18 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | CDE ↗ |
Ornidazole Injection 2 records · Latest accepted 2021/08/17
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2101599 | Generic | 2021/08/17 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | CDE ↗ |
| CYHS2101598 | Generic | 2021/08/17 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | CDE ↗ |
Changes in the last 90 days
3 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.
Accepted: 3 applications
- 2026/11/05Accepted
Mannitol-S Injection
CYHB2602013
Fact date: 2026/11/05 · Site observation date: 2026/11/06
View source ↗ - 2026/09/08Accepted
Foscarnet Sodium Injection
CYHB2601701
Fact date: 2026/09/08 · Site observation date: 2026/10/22
View source ↗ - 2026/08/20Accepted
磷酸二氢钠磷酸氢二钠颗粒 · No verified English name
CYHS2602070
Fact date: 2026/08/20 · Site observation date: 2026/10/22
View source ↗
Under review
4 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 |
|---|---|---|---|---|---|
| Mannitol-S Injection | CYHB2602013 | Supplement | 2026/11/05 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Foscarnet Sodium Injection | CYHB2601701 | Supplement | 2026/09/08 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| 磷酸二氢钠磷酸氢二钠颗粒 · No verified English name | CYHS2602070 | Generic | 2026/08/20 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CDE ↗ |
| 盐酸甲氧氯普胺口服溶液 · No verified English name | CYHS2501512 | Generic | 2025/04/22 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
Catalogue holder records
6 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 |
|---|---|---|---|---|---|---|
| Potassium Aspartate Injection | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20264617 | 2026/06/03 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Terlipressin for Injection | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20264541 | 2026/05/27 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Potassium Phosphates Injection | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20264206 | 2026/04/29 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Ornidazole Injection | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | 国药准字H20223838 | 2022/11/08 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Ornidazole Injection | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | 国药准字H20223837 | 2022/11/08 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Tranexamic Acid Injection | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | 国药准字H20223839 | 2022/11/08 | 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
26 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 |
|---|---|---|---|---|---|
| Acetylcysteine Oral Solution | CYHS2602277 | Generic | 2026/09/15 | Zhejiang Qian Jin Pharma Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Potassium Phosphates Injection | CYHB2601253 | Supplement | 2026/07/02 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Polyvinyl Alcohol Eye Drops | CYHS2600963 | Generic | 2026/04/25 | Shanghai Xiao Fang Pharmaceutical Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Amisulpride Oral Solution | CYHS2503000 | Generic | 2025/08/16 | Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Potassium Phosphates Injection | CYHB2501339 | Supplement | 2025/07/08 | Xizang Zhu Feng Shou Gao Bio Pharma Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Bilastine Oral Solution | CYHS2502060 | Generic | 2025/06/11 | Nanjing Huang Long Bio Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Polyvinyl Alcohol Eye Drops | CYHB2500943 | Supplement | 2025/05/10 | Jiangsu Jin Si Li Pharma Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| 苯磺酸氨氯地平口服溶液 · No verified English name | CYHS2501327 | Generic | 2025/04/08 | Shandong Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | CYHB2500577 | Supplement | 2025/03/21 | Hebei Jin Yi He Bio Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| 氧氟沙星滴耳液 · No verified English name | CYHS2404382 | Generic | 2024/12/17 | Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Potassium Phosphates Injection | CYHS2402537 | Generic | 2024/08/09 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Potassium Aspartate Injection | CYHS2402363 | Generic | 2024/07/26 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Ebastine Oral Solution | CYHS2402348 | Generic | 2024/07/26 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Potassium Aspartate Injection | CYHS2402191 | Generic | 2024/07/16 | Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Potassium Phosphates Injection | CYHS2402065 | Generic | 2024/07/08 | Shijiazhuang Di Si Kai Wei Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Terlipressin for Injection | CYHS2402033 | Generic | 2024/07/05 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Potassium Phosphates Injection | CYHS2401998 | Generic | 2024/07/03 | Yi Yao Tong (Hebei) Bio Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Tobramycin Eye Drops | CYHS2401965 | Generic | 2024/07/02 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Pranoprofen Eye Drops | CYHS2401898 | Generic | 2024/06/26 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| 醋酸来法莫林注射用浓溶液 · No verified English name | CYHS2401817 | Generic | 2024/06/18 | Zhu You Pharmaceutical (Suzhou) Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| 盐酸丙卡特罗吸入溶液 · No verified English name | CYHS2401777 | Generic | 2024/06/13 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Procaterol Hydrochloride Solution for Inhalation | CYHS2401557 | Generic | 2024/05/24 | Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Alendronate Sodium Oral Solution | CYHS2401335 | Generic | 2024/05/07 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Bromhexine Hydrochloride Oral Solution | CYHS2401117 | Generic | 2024/04/16 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | CYHS2401102 | Generic | 2024/04/13 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
| Loxoprofen Sodium Oral Solution | CYHS2400913 | Generic | 2024/03/26 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory 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.