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Company directoryChina company filings

Shandong Hao Rui En Pharmaceutical 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 b34509c9fb

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

7 acceptance records as first applicant, grouped into 6 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.

复方氨基酸注射液(18AA-VII) · No verified English name 2 records · Latest accepted 2026/10/13

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2602514Generic2026/10/13Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2502611Generic2025/07/19Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanizedCDE ↗
Sivelestat Sodium for Injection 1 records · Latest accepted 2026/06/01

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2601242Generic2026/06/01Shandong Hao Rui En Pharmaceutical Co., Ltd. romanizedCDE ↗
注射用盐酸地尔硫? · No verified English name 1 records · Latest accepted 2024/04/28

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2401285Generic2024/04/28Shandong Hao Rui En Pharmaceutical Co., Ltd. romanizedCDE ↗
Nefopam Hydrochloride Injection 1 records · Latest accepted 2023/12/27

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2303644Generic2023/12/27Shandong Hao Rui En Pharmaceutical Co., Ltd. romanizedCDE ↗
Roxatidine Acetate Hydrochloride For Injection 1 records · Latest accepted 2023/12/08

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2303400Generic2023/12/08Shandong Hao Rui En Pharmaceutical Co., Ltd. romanizedCDE ↗
Multiple Electrolyte Additive For Injection 1 records · Latest accepted 2023/09/12

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2302447Generic2023/09/12Shandong Hao Rui En Pharmaceutical Co., Ltd. romanizedCDE ↗

Changes in the last 90 days

1 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: 1 application

  1. 2026/10/13Accepted

    复方氨基酸注射液(18AA-VII) · No verified English name

    CYHS2602514

    Fact date: 2026/10/13 · Site observation date: 2026/10/22

    View source ↗

Under review

2 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
复方氨基酸注射液(18AA-VII) · No verified English name CYHS2602514Generic2026/10/13Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanizedCDE ↗
Sivelestat Sodium for Injection CYHS2601242Generic2026/06/01Shandong Hao Rui En Pharmaceutical Co., Ltd. romanizedCDE ↗

Catalogue holder records

4 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
Nefopam Hydrochloride InjectionShandong Hao Rui En Pharmaceutical Co., Ltd. romanizedShandong Hao Rui En Pharmaceutical Co., Ltd. romanized国药准字H202550352025/07/29Generic approved under the new chemical-drug registration classificationCDE ↗
注射用盐酸地尔硫䓬 · No verified English nameShandong Hao Rui En Pharmaceutical Co., Ltd. romanizedShandong Hao Rui En Pharmaceutical Co., Ltd. romanized国药准字H202548162025/07/08Generic approved under the new chemical-drug registration classificationCDE ↗
Roxatidine Acetate Hydrochloride For InjectionShandong Hao Rui En Pharmaceutical Co., Ltd. romanizedShandong Hao Rui En Pharmaceutical Co., Ltd. romanized国药准字H202545652025/06/17Generic approved under the new chemical-drug registration classificationCDE ↗
Multiple Electrolyte Additive For InjectionShandong Hao Rui En Pharmaceutical Co., Ltd. romanizedShandong Hao Rui En Pharmaceutical Co., Ltd. romanized国药准字H202540642025/05/13Generic 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

0 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
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

11 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
注射用磷酸左奥硝唑酯二钠 · No verified English name CYHS2503873Generic2025/11/05Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanizedCDE ↗
注射用托伐普坦磷酸钠 · No verified English name CYHS2503764Generic2025/10/22Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanizedCDE ↗
注射用托伐普坦磷酸钠 · No verified English name CYHS2503763Generic2025/10/22Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanizedCDE ↗
Acetylcysteine Injection CYHS2502541Generic2025/07/16Jinan Kang Qiao Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanizedCDE ↗
Acetylcysteine Injection CYHS2502043Generic2025/06/10Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanizedCDE ↗
Acetylcysteine Injection CYHS2502042Generic2025/06/10Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanizedCDE ↗
Polymyxin B sulfate for Injection CYHS2404191Generic2024/12/04Hefei Hua Wei Pharma Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanizedCDE ↗
Polymyxin B sulfate for Injection CYHS2403351Generic2024/10/10Yao Su (Shanghai) Medical Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanizedCDE ↗
Bumetanide Injection CYHS2402806Generic2024/08/29Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanizedCDE ↗
Bumetanide Injection CYHS2402805Generic2024/08/29Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanizedCDE ↗
维生素B6注射液 · No verified English name CYHS2303681Generic2023/12/30Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical 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.