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Company directoryChina company filings

Shandong Xin Hua Lu Kang Pharmaceuticals 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 9ed3c1333f

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

12 acceptance records as first applicant, grouped into 11 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.

聚乙二醇钠钾散 · No verified English name 2 records · Latest accepted 2026/04/01

Supplement · 1Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2600649Supplement2026/04/01Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanizedCDE ↗
CYHS2201777Generic2022/10/19Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanizedCDE ↗
Acetylcysteine Injection 1 records · Latest accepted 2026/03/02

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2600596Generic2026/03/02Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanizedCDE ↗
Methylprednisolone Sodium Succinate for injection 1 records · Latest accepted 2025/10/14

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2503641Generic2025/10/14Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
Acetylcysteine Solution For Inhalation 1 records · Latest accepted 2025/08/22

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2503075Generic2025/08/22Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanizedCDE ↗
Mepivacaine Hydrochloride Injection 1 records · Latest accepted 2025/07/15

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2501411Supplement2025/07/15Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanizedCDE ↗
Roxatidine Acetate Hydrochloride For Injection 1 records · Latest accepted 2024/12/24

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2404487Generic2024/12/24Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Shandong Yu Xin Pharma Co., Ltd. romanizedCDE ↗
Nicorandil for Injection 1 records · Latest accepted 2024/06/18

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2401820Generic2024/06/18Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
地氯雷他定口服溶液 · No verified English name 1 records · Latest accepted 2023/12/08

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2303390Generic2023/12/08Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanizedCDE ↗
Olmesartan Medoxomil Tablets 1 records · Latest accepted 2021/10/26

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2101915Generic2021/10/26Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanizedCDE ↗
Esomeprazole Sodium for Injection 1 records · Latest accepted 2021/09/26

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2101781Generic2021/09/26Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Hangzhou Ao Ya Bio Technology Co., Ltd. romanizedCDE ↗
Lansoprazole For Injection 1 records · Latest accepted 2021/04/27

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2101110Generic2021/04/27Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Hangzhou Ao Ya Bio Technology 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.

No longer listed under review: 1 application

  1. 2026/10/27No longer listed under review

    Roxatidine Acetate Hydrochloride For Injection

    CYHS2404487

    Fact date: 2026/10/27 · Site observation date: 2026/10/27

    Accepted: 2024/12/24

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗

Under review

3 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
Acetylcysteine Injection CYHS2600596Generic2026/03/02Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanizedCDE ↗
Methylprednisolone Sodium Succinate for injection CYHS2503641Generic2025/10/14Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
Acetylcysteine Solution For Inhalation CYHS2503075Generic2025/08/22Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanizedCDE ↗

Catalogue holder records

5 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
聚乙二醇钠钾散 · No verified English nameShandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanizedShandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized国药准字H202497342024/12/17Generic approved under the new chemical-drug registration classificationCDE ↗
Esomeprazole Sodium for InjectionShandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanizedHangzhou Ao Ya Bio Technology Co., Ltd. romanized国药准字H202332002023/02/21Generic approved under the new chemical-drug registration classificationCDE ↗
Olmesartan Medoxomil TabletsShandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanizedHua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized国药准字H202330722023/01/19Generic approved under the new chemical-drug registration classificationCDE ↗
Lansoprazole For InjectionShandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanizedHangzhou Ao Ya Bio Technology Co., Ltd. romanized国药准字H202238312022/11/08Generic approved under the new chemical-drug registration classificationCDE ↗
Methylprednisolone TabletsShandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanizedShandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized国药准字H202136712021/08/25Generic 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

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.

Co-applicant records
Drug Acceptance numberApplication typeAcceptedCompany / applicantView 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.