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
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
Brexpiprazole Tablets 3 records · Latest accepted 2026/08/13
Generic · 3
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2601991 | Generic | 2026/08/13 | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2601990 | Generic | 2026/08/13 | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2601989 | Generic | 2026/08/13 | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Trazodone Hydrochloride Tablets 1 records · Latest accepted 2026/04/18
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2600782 | Supplement | 2026/04/18 | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized; Hebei Long Hai Pharma Co., Ltd. romanized | CDE ↗ |
Azilsartan Medoxomil Potassium Tablets 2 records · Latest accepted 2026/01/09
Generic · 2
Divalproex Sodium Extended-Release Tablets 2 records · Latest accepted 2025/12/17
Generic · 2
愈风宁心颗粒 · No verified English name 1 records · Latest accepted 2025/08/20
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYZB2501812 | Supplement | 2025/08/20 | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Nicorandil Tablets 1 records · Latest accepted 2024/11/28
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2450571 | Supplement | 2024/11/28 | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Losartan Potassium and Hydrochlorothiazide Tablets 1 records · Latest accepted 2023/07/21
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2350588 | Supplement | 2023/07/21 | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Lorazepam Tablets 1 records · Latest accepted 2023/05/16
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2350445 | Supplement | 2023/05/16 | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Diazepam Tablets 2 records · Latest accepted 2022/01/18
Supplement · 2
Flunarizine Hydrochloride Capsules 1 records · Latest accepted 2021/01/23
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2150062 | Supplement | 2021/01/23 | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CDE ↗ |
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
- 2026/10/14Accepted
Zolpidem tartrate extended-release tablets
CYHL2600117
Fact date: 2026/10/14 · Site observation date: 2026/10/22
View source ↗ - 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.
| Drug | Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|---|
| Zolpidem tartrate extended-release tablets | CYHL2600117 | Generic | 2026/10/14 | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Zolpidem tartrate extended-release tablets | CYHL2600116 | Generic | 2026/10/14 | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Brexpiprazole Tablets | CYHS2601991 | Generic | 2026/08/13 | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Brexpiprazole Tablets | CYHS2601990 | Generic | 2026/08/13 | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Brexpiprazole Tablets | CYHS2601989 | Generic | 2026/08/13 | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Azilsartan Medoxomil Potassium Tablets | CYHS2600103 | Generic | 2026/01/09 | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Azilsartan Medoxomil Potassium Tablets | CYHS2600102 | Generic | 2026/01/09 | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CDE ↗ |
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.
| Drug | Marketing authorization holder | Manufacturer | Approval number | Approved | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Nicorandil Tablets | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | 国药准字H37023300 | 2025/09/15 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Losartan Potassium and Hydrochlorothiazide Tablets | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20103417 | 2024/07/31 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Lorazepam Tablets | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20060105 | 2024/03/01 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Diazepam Tablets | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | 国药准字H37023039 | 2023/05/06 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Flunarizine Hydrochloride Capsules | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | 国药准字H37021441 | 2022/02/18 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Estazolam Tablets | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | 国药准字H37023047 | 2021/05/06 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Nitroglycerin Sublingual Tablets | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | 国药准字H37021445 | 2020/12/15 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Alprazolam Tablets | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | 国药准字H37021444 | 2020/11/24 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Amiodarone Hydrochloride Tablets | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | 国药准字H37021456 | 2020/09/25 | Drug that passed quality-and-efficacy consistency evaluation | 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
25 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 |
|---|---|---|---|---|---|
| 美阿沙坦钾 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20250001339 | I | 2026/01/06 | CDE ↗ |
| 布瑞哌唑 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20250001338 | I | 2025/12/23 | CDE ↗ |
| 马来酸阿伐曲泊帕 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20250001277 | I | 2025/12/03 | CDE ↗ |
| 华法林钠 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20220001167 | A | 2024/06/07 | CDE ↗ |
| 硫普罗宁 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190007762 | A | 2025/02/14 | CDE ↗ |
| 艾司唑仑 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190006901 | A | 2026/06/18 | CDE ↗ |
| 氯沙坦钾 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190006900 | A | — | CDE ↗ |
| 替米沙坦 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190006111 | A | 2025/12/09 | CDE ↗ |
| 劳拉西泮 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190005955 | A | 2026/06/18 | CDE ↗ |
| 盐酸氟桂利嗪 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190002084 | A | 2025/02/12 | CDE ↗ |
| 富马酸亚铁 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190002073 | A | 2025/02/14 | CDE ↗ |
| 芬布芬 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190002033 | A | 2025/03/04 | CDE ↗ |
| 硝酸甘油溶液 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190002032 | A | 2025/02/12 | CDE ↗ |
| 盐酸酚苄明 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190002031 | A | 2025/02/11 | CDE ↗ |
| 盐酸二氧丙嗪 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190002030 | A | 2025/02/12 | CDE ↗ |
| 盐酸胺碘酮 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190002029 | A | 2025/02/12 | CDE ↗ |
| 去甲斑蝥素 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190002028 | A | 2025/02/14 | CDE ↗ |
| 阿普唑仑 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190002025 | A | 2026/06/18 | CDE ↗ |
| 盐酸哌唑嗪 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190002024 | A | 2025/02/12 | CDE ↗ |
| 磷酸苯丙哌林 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190002023 | A | 2025/02/14 | CDE ↗ |
| 盐酸奈福泮 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190002022 | A | 2025/02/14 | CDE ↗ |
| 盐酸普罗帕酮 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190002021 | A | 2026/06/16 | CDE ↗ |
| 尼可地尔 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190002006 | A | 2025/02/12 | CDE ↗ |
| 奥扎格雷 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190001996 | A | 2025/03/04 | CDE ↗ |
| 地西泮 · No verified English name | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190001976 | A | 2025/03/19 | CDE ↗ |
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.