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Company directoryChina company filings

Shanxi Xin Yu 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 c5b3f2c203

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

11 acceptance records as first applicant, grouped into 7 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.

Pemafibrate Tablets 1 records · Latest accepted 2025/09/28

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2503548Generic2025/09/28Shanxi Xin Yu Pharmaceutical Co., Ltd. romanizedCDE ↗
Nicorandil Tablets 4 records · Latest accepted 2025/05/28

Supplement · 4

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2501086Supplement2025/05/28Shanxi Xin Yu Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2401674Supplement2024/10/17Shanxi Xin Yu Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2250317Supplement2022/06/03Shanxi Xin Yu Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2250316Supplement2022/06/03Shanxi Xin Yu Pharmaceutical Co., Ltd. romanizedCDE ↗
Omega-3-acid ethyl ester 90 Soft Capsules 1 records · Latest accepted 2025/01/21

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2500369Generic2025/01/21Shanxi Xin Yu Pharmaceutical Co., Ltd. romanized; Da Lian Mei Chuang Pharma Co., Ltd. romanizedCDE ↗
Benidipine Hydrochloride Tablets 2 records · Latest accepted 2024/02/23

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400672Generic2024/02/23Shanxi Xin Yu Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2400671Generic2024/02/23Shanxi Xin Yu Pharmaceutical Co., Ltd. romanizedCDE ↗
口服五维葡萄糖 · No verified English name 1 records · Latest accepted 2023/11/17

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2302550Supplement2023/11/17Shanxi Xin Yu Pharmaceutical Co., Ltd. romanizedCDE ↗
Olmesartan Medoxomil and Amlodipine Besylate Tablets 1 records · Latest accepted 2023/09/05

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2302372Generic2023/09/05Shanxi Xin Yu Pharmaceutical Co., Ltd. romanizedCDE ↗
维生素B6片 · No verified English name 1 records · Latest accepted 2023/03/24

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2350287Supplement2023/03/24Shanxi Xin Yu Pharmaceutical Co., Ltd. romanizedCDE ↗

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.

  1. No matching records were found in the currently loaded source data; coverage dates are listed below.

Under review

1 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
Pemafibrate Tablets CYHS2503548Generic2025/09/28Shanxi Xin Yu Pharmaceutical Co., Ltd. romanizedCDE ↗

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.

DrugMarketing authorization holderManufacturerApproval numberApprovedCatalogue category (source text)View source
Omega-3-acid ethyl ester 90 Soft CapsulesShanxi Xin Yu Pharmaceutical Co., Ltd. romanizedDa Lian Mei Chuang Pharma Co., Ltd. romanized国药准字H202640702026/04/21Generic approved under the new chemical-drug registration classificationCDE ↗
Nicorandil TabletsShanxi Xin Yu Pharmaceutical Co., Ltd. romanizedShanxi Xin Yu Pharmaceutical Co., Ltd. romanized国药准字H202582762025/12/08Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Benidipine Hydrochloride TabletsShanxi Xin Yu Pharmaceutical Co., Ltd. romanizedShanxi Xin Yu Pharmaceutical Co., Ltd. romanized国药准字H202546562025/06/24Generic approved under the new chemical-drug registration classificationCDE ↗
Benidipine Hydrochloride TabletsShanxi Xin Yu Pharmaceutical Co., Ltd. romanizedShanxi Xin Yu Pharmaceutical Co., Ltd. romanized国药准字H202546572025/06/24Generic approved under the new chemical-drug registration classificationCDE ↗
Olmesartan Medoxomil and Amlodipine Besylate TabletsShanxi Xin Yu Pharmaceutical Co., Ltd. romanizedShanxi Xin Yu Pharmaceutical Co., Ltd. romanized国药准字H202497872024/12/25Generic approved under the new chemical-drug registration classificationCDE ↗
Nicorandil TabletsShanxi Xin Yu Pharmaceutical Co., Ltd. romanizedShanxi Xin Yu Pharmaceutical Co., Ltd. romanized国药准字H140227372023/06/07Drug that passed quality-and-efficacy consistency evaluationCDE ↗

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

3 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
Dotinurad Tablets CYHS2600158Generic2026/01/13Shanxi Ze Chen Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Xin Yu Pharmaceutical Co., Ltd. romanizedCDE ↗
Dotinurad Tablets CYHS2600156Generic2026/01/13Shanxi Ze Chen Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Xin Yu Pharmaceutical Co., Ltd. romanizedCDE ↗
小儿氨酚黄那敏片 · No verified English name CYHB2402118Supplement2024/12/12Shanxi Ze Chen Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Xin Yu 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.