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Company directoryChina company filings

Shandong Xin Yi 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 1d04b72fe4

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

17 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.

Zolpidem tartrate extended-release tablets 2 records · Latest accepted 2026/10/14

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHL2600117Generic2026/10/14Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHL2600116Generic2026/10/14Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
Brexpiprazole Tablets 3 records · Latest accepted 2026/08/13

Generic · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2601991Generic2026/08/13Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2601990Generic2026/08/13Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2601989Generic2026/08/13Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
Trazodone Hydrochloride Tablets 1 records · Latest accepted 2026/04/18

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2600782Supplement2026/04/18Shandong Xin Yi Pharmaceutical Co., Ltd. romanized; Hebei Long Hai Pharma Co., Ltd. romanizedCDE ↗
Azilsartan Medoxomil Potassium Tablets 2 records · Latest accepted 2026/01/09

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2600103Generic2026/01/09Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2600102Generic2026/01/09Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
Divalproex Sodium Extended-Release Tablets 2 records · Latest accepted 2025/12/17

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHL2500224Generic2025/12/17Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHL2500223Generic2025/12/17Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
愈风宁心颗粒 · No verified English name 1 records · Latest accepted 2025/08/20

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYZB2501812Supplement2025/08/20Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
Nicorandil Tablets 1 records · Latest accepted 2024/11/28

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2450571Supplement2024/11/28Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
Losartan Potassium and Hydrochlorothiazide Tablets 1 records · Latest accepted 2023/07/21

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2350588Supplement2023/07/21Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
Lorazepam Tablets 1 records · Latest accepted 2023/05/16

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2350445Supplement2023/05/16Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
Diazepam Tablets 2 records · Latest accepted 2022/01/18

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2250047Supplement2022/01/18Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2250046Supplement2022/01/18Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
Flunarizine Hydrochloride Capsules 1 records · Latest accepted 2021/01/23

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2150062Supplement2021/01/23Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗

Changes in the last 90 days

2 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: 2 applications

  1. 2026/10/14Accepted

    Zolpidem tartrate extended-release tablets

    CYHL2600117

    Fact date: 2026/10/14 · Site observation date: 2026/10/22

    View source ↗
  2. 2026/10/14Accepted

    Zolpidem tartrate extended-release tablets

    CYHL2600116

    Fact date: 2026/10/14 · Site observation date: 2026/10/22

    View source ↗

Under review

7 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
Zolpidem tartrate extended-release tablets CYHL2600117Generic2026/10/14Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
Zolpidem tartrate extended-release tablets CYHL2600116Generic2026/10/14Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
Brexpiprazole Tablets CYHS2601991Generic2026/08/13Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
Brexpiprazole Tablets CYHS2601990Generic2026/08/13Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
Brexpiprazole Tablets CYHS2601989Generic2026/08/13Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
Azilsartan Medoxomil Potassium Tablets CYHS2600103Generic2026/01/09Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗
Azilsartan Medoxomil Potassium Tablets CYHS2600102Generic2026/01/09Shandong Xin Yi Pharmaceutical Co., Ltd. romanizedCDE ↗

Catalogue holder records

9 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
Nicorandil TabletsShandong Xin Yi Pharmaceutical Co., Ltd. romanizedShandong Xin Yi Pharmaceutical Co., Ltd. romanized国药准字H370233002025/09/15Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Losartan Potassium and Hydrochlorothiazide TabletsShandong Xin Yi Pharmaceutical Co., Ltd. romanizedShandong Xin Yi Pharmaceutical Co., Ltd. romanized国药准字H201034172024/07/31Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Lorazepam TabletsShandong Xin Yi Pharmaceutical Co., Ltd. romanizedShandong Xin Yi Pharmaceutical Co., Ltd. romanized国药准字H200601052024/03/01Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Diazepam TabletsShandong Xin Yi Pharmaceutical Co., Ltd. romanizedShandong Xin Yi Pharmaceutical Co., Ltd. romanized国药准字H370230392023/05/06Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Flunarizine Hydrochloride CapsulesShandong Xin Yi Pharmaceutical Co., Ltd. romanizedShandong Xin Yi Pharmaceutical Co., Ltd. romanized国药准字H370214412022/02/18Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Estazolam TabletsShandong Xin Yi Pharmaceutical Co., Ltd. romanizedShandong Xin Yi Pharmaceutical Co., Ltd. romanized国药准字H370230472021/05/06Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Nitroglycerin Sublingual TabletsShandong Xin Yi Pharmaceutical Co., Ltd. romanizedShandong Xin Yi Pharmaceutical Co., Ltd. romanized国药准字H370214452020/12/15Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Alprazolam TabletsShandong Xin Yi Pharmaceutical Co., Ltd. romanizedShandong Xin Yi Pharmaceutical Co., Ltd. romanized国药准字H370214442020/11/24Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Amiodarone Hydrochloride TabletsShandong Xin Yi Pharmaceutical Co., Ltd. romanizedShandong Xin Yi Pharmaceutical Co., Ltd. romanized国药准字H370214562020/09/25Drug 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

25 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
美阿沙坦钾 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20250001339I2026/01/06CDE ↗
布瑞哌唑 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20250001338I2025/12/23CDE ↗
马来酸阿伐曲泊帕 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20250001277I2025/12/03CDE ↗
华法林钠 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20220001167A2024/06/07CDE ↗
硫普罗宁 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190007762A2025/02/14CDE ↗
艾司唑仑 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190006901A2026/06/18CDE ↗
氯沙坦钾 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190006900A—CDE ↗
替米沙坦 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190006111A2025/12/09CDE ↗
劳拉西泮 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190005955A2026/06/18CDE ↗
盐酸氟桂利嗪 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190002084A2025/02/12CDE ↗
富马酸亚铁 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190002073A2025/02/14CDE ↗
芬布芬 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190002033A2025/03/04CDE ↗
硝酸甘油溶液 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190002032A2025/02/12CDE ↗
盐酸酚苄明 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190002031A2025/02/11CDE ↗
盐酸二氧丙嗪 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190002030A2025/02/12CDE ↗
盐酸胺碘酮 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190002029A2025/02/12CDE ↗
去甲斑蝥素 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190002028A2025/02/14CDE ↗
阿普唑仑 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190002025A2026/06/18CDE ↗
盐酸哌唑嗪 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190002024A2025/02/12CDE ↗
磷酸苯丙哌林 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190002023A2025/02/14CDE ↗
盐酸奈福泮 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190002022A2025/02/14CDE ↗
盐酸普罗帕酮 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190002021A2026/06/16CDE ↗
尼可地尔 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190002006A2025/02/12CDE ↗
奥扎格雷 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190001996A2025/03/04CDE ↗
地西泮 · No verified English nameShandong Xin Yi Pharmaceutical Co., Ltd. romanizedY20190001976A2025/03/19CDE ↗

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.