Shandong Ru Zhi Biopharmaceuticals Technology 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 a7fcd34275
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
32 acceptance records as first applicant, grouped into 26 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.
Candesartan Cilexetil and Hydrochlorothiazide Tablets(II) 1 records · Latest accepted 2026/02/25
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2600527 | Generic | 2026/02/25 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | CDE ↗ |
双氯芬酸钠盐酸利多卡因注射液 · No verified English name 1 records · Latest accepted 2025/07/30
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2502748 | Generic | 2025/07/30 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Ya Bao Pharma Group Co., Ltd. romanized | CDE ↗ |
Acetylcysteine Injection 4 records · Latest accepted 2025/06/26
Generic · 4
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2502286 | Generic | 2025/06/26 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | CDE ↗ |
| CYHS2502043 | Generic | 2025/06/10 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2502042 | Generic | 2025/06/10 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2303489 | Generic | 2023/12/15 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | CDE ↗ |
Ioversol Injection 1 records · Latest accepted 2025/02/08
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2500626 | Generic | 2025/02/08 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Bei Lu Pharma Co., Ltd. romanized | CDE ↗ |
盐酸尼卡地平氯化钠注射液 · No verified English name 1 records · Latest accepted 2024/08/28
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2402794 | Generic | 2024/08/28 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Potassium Phosphates Injection 1 records · Latest accepted 2024/08/09
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2402537 | Generic | 2024/08/09 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
Cytarabine for Injection 1 records · Latest accepted 2024/07/27
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2402375 | Generic | 2024/07/27 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Cheng Kang Pharma Co., Ltd. romanized | CDE ↗ |
Ebastine Oral Solution 1 records · Latest accepted 2024/07/26
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| 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 1 records · Latest accepted 2024/07/26
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2402363 | Generic | 2024/07/26 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
Mupirocin Ointment 1 records · Latest accepted 2024/07/23
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2402324 | Generic | 2024/07/23 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Jing Wei Pharma Co., Ltd. romanized | CDE ↗ |
Terlipressin for Injection 1 records · Latest accepted 2024/07/05
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2402033 | Generic | 2024/07/05 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
Tobramycin Eye Drops 1 records · Latest accepted 2024/07/02
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| 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 1 records · Latest accepted 2024/06/26
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2401898 | Generic | 2024/06/26 | Shandong Ru Zhi Biopharmaceuticals Technology 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 1 records · Latest accepted 2024/06/13
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2401777 | Generic | 2024/06/13 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
盐酸纳美芬注射液 · No verified English name 1 records · Latest accepted 2024/05/22
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2401539 | Generic | 2024/05/22 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Alendronate Sodium Oral Solution 1 records · Latest accepted 2024/05/07
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2401335 | Generic | 2024/05/07 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
Metoclopramide Hydrochloride Injection 1 records · Latest accepted 2024/04/19
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2401171 | Generic | 2024/04/19 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | CDE ↗ |
Nicardipine Hydrochloride Injection 1 records · Latest accepted 2024/04/16
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2401120 | Generic | 2024/04/16 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Bromhexine Hydrochloride Oral Solution 1 records · Latest accepted 2024/04/16
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2401117 | Generic | 2024/04/16 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
Lornoxicam for Injection 1 records · Latest accepted 2024/04/13
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2400497 | Supplement | 2024/04/13 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized | CDE ↗ |
Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution 1 records · Latest accepted 2024/04/13
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2401102 | Generic | 2024/04/13 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | CDE ↗ |
Oxacillin Sodium for Injection 2 records · Latest accepted 2024/01/15
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2400211 | Generic | 2024/01/15 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Er Ye Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2400210 | Generic | 2024/01/15 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Er Ye Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Amoxicillin Sodium and Sulbactam Sodium for Injection 2 records · Latest accepted 2024/01/05
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2400058 | Generic | 2024/01/05 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CDE ↗ |
| CYHS2400057 | Generic | 2024/01/05 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CDE ↗ |
Morinidazole and Sodium Chloride Injection 1 records · Latest accepted 2024/01/04
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2400039 | Generic | 2024/01/04 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized | CDE ↗ |
注射用头孢唑肟钠 · No verified English name 2 records · Latest accepted 2023/07/21
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2301957 | Generic | 2023/07/21 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shenyang San Jiu Pharma Co., Ltd. romanized | CDE ↗ |
| CYHS2301956 | Generic | 2023/07/21 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shenyang San Jiu Pharma Co., Ltd. romanized | CDE ↗ |
Penicillin G Sodium For Injection 1 records · Latest accepted 2023/02/07
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2300364 | Generic | 2023/02/07 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CDE ↗ |
Changes in the last 90 days
0 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 matching records were found in the currently loaded source data; coverage dates are listed below.
Under review
6 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 |
|---|---|---|---|---|---|
| Candesartan Cilexetil and Hydrochlorothiazide Tablets(II) | CYHS2600527 | Generic | 2026/02/25 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | CDE ↗ |
| 双氯芬酸钠盐酸利多卡因注射液 · No verified English name | CYHS2502748 | Generic | 2025/07/30 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Ya Bao Pharma Group Co., Ltd. romanized | CDE ↗ |
| Acetylcysteine Injection | CYHS2502286 | Generic | 2025/06/26 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized | CDE ↗ |
| Acetylcysteine Injection | CYHS2502043 | Generic | 2025/06/10 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Amoxicillin Sodium and Sulbactam Sodium for Injection | CYHS2400058 | Generic | 2024/01/05 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CDE ↗ |
| Amoxicillin Sodium and Sulbactam Sodium for Injection | CYHS2400057 | Generic | 2024/01/05 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CDE ↗ |
Catalogue holder records
7 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 |
|---|---|---|---|---|---|---|
| Metoclopramide Hydrochloride Injection | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized | Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | 国药准字H20256185 | 2025/12/09 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Oxacillin Sodium for Injection | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 国药准字H20255003 | 2025/07/29 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Oxacillin Sodium for Injection | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 国药准字H20255004 | 2025/07/29 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| 注射用头孢唑肟钠 · No verified English name | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized | Shenyang San Jiu Pharma Co., Ltd. romanized | 国药准字H20249249 | 2024/11/05 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| 注射用头孢唑肟钠 · No verified English name | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized | Shenyang San Jiu Pharma Co., Ltd. romanized | 国药准字H20249248 | 2024/11/05 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Lornoxicam for Injection | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized | Chengdu Tong De Pharma Co., Ltd. romanized | 国药准字H20243747 | 2024/05/21 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Penicillin G Sodium For Injection | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized | NORTH CHINA PHARMACEUTICAL COMPANY.LTD | 国药准字H20243691 | 2024/05/15 | 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
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.