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Company directoryChina company filings

Shandong Zi Bo Xin Da 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 ba24428652

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

25 acceptance records as first applicant, grouped into 23 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.

Febuxostat Tablets 2 records · Latest accepted 2026/08/28

Supplement · 1Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2601655Supplement2026/08/28Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2301652Generic2023/06/19Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
Cefaclor Capsules 2 records · Latest accepted 2026/03/19

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2600531Supplement2026/03/19Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2250649Supplement2022/10/19Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
Azithromycin Tablets 1 records · Latest accepted 2025/09/29

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2550334Supplement2025/09/29Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
盐酸多奈哌齐口崩片 · No verified English name 1 records · Latest accepted 2025/02/09

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2500658Generic2025/02/09Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
Saxagliptin and Metformin Hydrochloride Sustained-release Tablets 1 records · Latest accepted 2024/06/29

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2401958Generic2024/06/29Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
Saxagliptin and Metformin Hydrochloride Sustained-release Tablets 1 records · Latest accepted 2024/06/29

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2401959Generic2024/06/29Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
Azithromycin for Suspension 1 records · Latest accepted 2024/02/29

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2450159Supplement2024/02/29Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
Ursodeoxycholic Acid Capsules 1 records · Latest accepted 2024/01/30

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400384Generic2024/01/30Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
Ivabradine Hydrochloride Tablets 1 records · Latest accepted 2024/01/17

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400236Generic2024/01/17Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
Finasteride Tablets 1 records · Latest accepted 2024/01/11

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400153Generic2024/01/11Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
克拉霉素干混悬剂 · No verified English name 1 records · Latest accepted 2023/12/22

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2303570Generic2023/12/22Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanizedCDE ↗
Ibuprofen Granules 1 records · Latest accepted 2023/12/19

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2303506Generic2023/12/19Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
Bromhexine Hydrochloride Tablets 1 records · Latest accepted 2023/10/18

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2302308Supplement2023/10/18Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized; Fujian Zhong He Pharmaceuticals Co., Ltd. romanizedCDE ↗
吡哌酸胶囊 · No verified English name 1 records · Latest accepted 2023/09/27

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2302197Supplement2023/09/27Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized; Jilin Hua Kang Pharma Co., Ltd. romanizedCDE ↗
Furosemide Tablets 1 records · Latest accepted 2023/09/27

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2302198Supplement2023/09/27Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized; Jilin Xian Feng Technology Pharmaceutical Co., Ltd. romanizedCDE ↗
头孢呋辛酯分散片 · No verified English name 1 records · Latest accepted 2023/07/04

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2350519Supplement2023/07/04Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
头孢克肟胶囊 · No verified English name 1 records · Latest accepted 2022/11/01

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2250675Supplement2022/11/01Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
Flunarizine Hydrochloride Capsules 1 records · Latest accepted 2022/10/27

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2201975Supplement2022/10/27Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanizedCDE ↗
小儿氨酚黄那敏颗粒 · No verified English name 1 records · Latest accepted 2022/06/14

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2200969Supplement2022/06/14Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized; Sheng Da (Zhang Jia Kou) Pharma Co., Ltd. romanizedCDE ↗
Ursodeoxycholic Acid Tablets 1 records · Latest accepted 2022/05/05

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2200721Supplement2022/05/05Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized; Shandong Si Bang De Pharmaceutical Co., Ltd. romanizedCDE ↗
头孢克洛颗粒 · No verified English name 1 records · Latest accepted 2021/09/26

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2150884Supplement2021/09/26Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
头孢克洛缓释片 · No verified English name 1 records · Latest accepted 2021/07/08

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2150719Supplement2021/07/08Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
盐酸吡格列酮胶囊 · No verified English name 1 records · Latest accepted 2021/03/24

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2150519Supplement2021/03/24Shandong Zi Bo Xin Da 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. 2026/08/28Accepted

    Febuxostat Tablets

    CYHB2601655

    Fact date: 2026/08/28 · Site observation date: 2026/10/22

    View source ↗

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
Febuxostat Tablets CYHB2601655Supplement2026/08/28Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗

Catalogue holder records

17 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
Azithromycin TabletsShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized国药准字H200834792026/08/27Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Ibuprofen GranulesShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized国药准字H202636212026/03/17Generic approved under the new chemical-drug registration classificationCDE ↗
Saxagliptin and Metformin Hydrochloride Sustained-release TabletsShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized国药准字H202634452026/02/25Generic approved under the new chemical-drug registration classificationCDE ↗
Saxagliptin and Metformin Hydrochloride Sustained-release TabletsShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized国药准字H202633982026/02/10Generic approved under the new chemical-drug registration classificationCDE ↗
克拉霉素干混悬剂 · No verified English nameShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedXin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized国药准字H202551162025/08/19Generic approved under the new chemical-drug registration classificationCDE ↗
Finasteride TabletsShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized国药准字H202550642025/07/30Generic approved under the new chemical-drug registration classificationCDE ↗
Ivabradine Hydrochloride TabletsShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized国药准字H202546262025/06/24Generic approved under the new chemical-drug registration classificationCDE ↗
Azithromycin for SuspensionShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized国药准字H200941262024/11/29Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Febuxostat TabletsShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized国药准字H202492712024/11/05Generic approved under the new chemical-drug registration classificationCDE ↗
头孢呋辛酯分散片 · No verified English nameShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized国药准字H201432702024/10/29Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Cefaclor CapsulesShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized国药准字H109300082024/04/07Drug that passed quality-and-efficacy consistency evaluationCDE ↗
头孢克肟胶囊 · No verified English nameShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized国药准字H200703102023/11/29Drug that passed quality-and-efficacy consistency evaluationCDE ↗
头孢克洛颗粒 · No verified English nameShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized国药准字H109600052022/10/18Drug that passed quality-and-efficacy consistency evaluationCDE ↗
头孢克洛缓释片 · No verified English nameShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized国药准字H200404022022/09/14Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Amoxicillin CapsulesShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized国药准字H370204702022/01/06Drug that passed quality-and-efficacy consistency evaluationCDE ↗
盐酸吡格列酮胶囊 · No verified English nameShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized国药准字H200606212022/01/06Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Ursodeoxycholic Acid CapsulesShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedShandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized国药准字H202553442025/09/09Generic 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

7 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
头孢克肟胶囊 · No verified English name CYHS2601412Generic2026/06/15Hunan Zhuang Yuan Pharmaceutical Co., Ltd. romanized; Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
人工牛黄甲硝唑胶囊 · No verified English name CYHB2600473Supplement2026/03/09SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
Sacubitril Valsartan Sodium Tablets CYHS2503714Generic2025/10/17Shandong Nuo Ming Kang Drug Research Institute Co., Ltd. romanized; Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
Dapoxetine Hydrochloride Tablets CYHS2501422Generic2025/04/14SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
Entacapone Tablets CYHS2403452Generic2024/10/15SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanizedCDE ↗
Tofacitinib Citrate Tablets CYHB2302110Supplement2023/09/16SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized; Nanjing Ke Fei Ping Sheng Hui Pharmaceutical Co., Ltd. romanizedCDE ↗
Digoxin Tablets CYHB2300533Supplement2023/03/10SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Shandong Zi Bo Xin Da 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.