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Shandong Dan Hong 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 18ec5b842f

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

31 acceptance records as first applicant, grouped into 19 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.

Mirogabalin Besilate Tablets 2 records · Latest accepted 2026/07/31

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2601844Generic2026/07/31Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shandong Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2601843Generic2026/07/31Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shandong Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
Empagliflozin Tablets 3 records · Latest accepted 2026/07/21

Generic · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2601744Generic2026/07/21Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanizedCDE ↗
CYHS2500838Generic2025/02/25Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanizedCDE ↗
CYHS2201035Generic2022/07/08Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanizedCDE ↗
益气活血解郁颗粒 · No verified English name 1 records · Latest accepted 2026/07/09

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CXZB2600008Supplement2026/07/09Shandong Dan Hong Pharmaceutical Co., Ltd. romanizedCDE ↗
Dapagliflozin Tablets 2 records · Latest accepted 2026/06/18

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2601446Generic2026/06/18Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2601445Generic2026/06/18Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
Loxoprofen Sodium Oral Solution 1 records · Latest accepted 2026/06/05

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2601315Generic2026/06/05Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
Lenalidomide Capsules 1 records · Latest accepted 2026/02/14

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2600483Generic2026/02/14Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
Iron Proteinsuccinylate Oral Solution 1 records · Latest accepted 2025/09/26

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2503520Generic2025/09/26Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shandong Kang Ai Pharmaceutical Co., Ltd. romanizedCDE ↗
Mecobalamin Tablets 1 records · Latest accepted 2024/12/04

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2404182Generic2024/12/04Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
Sitagliptin Phosphate Tablets 3 records · Latest accepted 2024/09/20

Supplement · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2401533Supplement2024/09/20Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2401532Supplement2024/09/20Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2401531Supplement2024/09/20Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
Ibuprofen Sustained Release Capsules 1 records · Latest accepted 2024/05/12

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2401429Generic2024/05/12Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shandong Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
Montelukast Sodium Chewable Tablets 2 records · Latest accepted 2023/08/23

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2302243Generic2023/08/23Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shandong Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2302242Generic2023/08/23Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shandong Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
Levetiracetam extended-release tablets 2 records · Latest accepted 2023/02/18

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2300567Generic2023/02/18Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2300565Generic2023/02/18Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
Ezetimibe Tablets 1 records · Latest accepted 2023/01/05

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2300031Generic2023/01/05Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shandong Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
Dapoxetine Hydrochloride Tablets 2 records · Latest accepted 2022/06/29

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2200974Generic2022/06/29Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2200973Generic2022/06/29Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
BC0305胶囊 · No verified English name 2 records · Latest accepted 2021/12/16

New drug · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CXHL2101749New drug2021/12/16Shandong Dan Hong Pharmaceutical Co., Ltd. romanizedCDE ↗
CXHL2101748New drug2021/12/16Shandong Dan Hong Pharmaceutical Co., Ltd. romanizedCDE ↗
BC0306胶囊 · No verified English name 2 records · Latest accepted 2021/12/10

New drug · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CXHL2101733New drug2021/12/10Shandong Dan Hong Pharmaceutical Co., Ltd. romanizedCDE ↗
CXHL2101732New drug2021/12/10Shandong Dan Hong Pharmaceutical Co., Ltd. romanizedCDE ↗
Pregabalin Capsules 2 records · Latest accepted 2021/12/01

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2102116Generic2021/12/01Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shandong Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2102115Generic2021/12/01Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shandong Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
Desloratadine Tablets 1 records · Latest accepted 2021/04/15

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2101065Generic2021/04/15Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shandong Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
注射用奥美拉唑钠(静脉滴注) · No verified English name 1 records · Latest accepted 2021/03/04

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2100240Generic2021/03/04Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shandong Kang Ai 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

8 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
Mirogabalin Besilate Tablets CYHS2601844Generic2026/07/31Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shandong Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
Mirogabalin Besilate Tablets CYHS2601843Generic2026/07/31Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shandong Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
Empagliflozin Tablets CYHS2601744Generic2026/07/21Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanizedCDE ↗
Dapagliflozin Tablets CYHS2601446Generic2026/06/18Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
Dapagliflozin Tablets CYHS2601445Generic2026/06/18Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
Loxoprofen Sodium Oral Solution CYHS2601315Generic2026/06/05Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
Lenalidomide Capsules CYHS2600483Generic2026/02/14Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanizedCDE ↗
Iron Proteinsuccinylate Oral Solution CYHS2503520Generic2025/09/26Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shandong Kang Ai Pharmaceutical Co., Ltd. romanizedCDE ↗

Catalogue holder records

15 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
Ibuprofen Sustained Release CapsulesShandong Dan Hong Pharmaceutical Co., Ltd. romanizedShandong Bu Zhang Pharmaceutical Co., Ltd. romanized国药准字H202556562025/09/30Generic approved under the new chemical-drug registration classificationCDE ↗
Sitagliptin Phosphate TabletsShandong Dan Hong Pharmaceutical Co., Ltd. romanizedShaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized国药准字H202493262024/11/15Generic approved under the new chemical-drug registration classificationCDE ↗
Sitagliptin Phosphate TabletsShandong Dan Hong Pharmaceutical Co., Ltd. romanizedShaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized国药准字H202493242024/11/15Generic approved under the new chemical-drug registration classificationCDE ↗
Sitagliptin Phosphate TabletsShandong Dan Hong Pharmaceutical Co., Ltd. romanizedShaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized国药准字H202493252024/11/15Generic approved under the new chemical-drug registration classificationCDE ↗
Montelukast Sodium Chewable TabletsShandong Dan Hong Pharmaceutical Co., Ltd. romanizedShandong Bu Zhang Pharmaceutical Co., Ltd. romanized国药准字H202493282024/11/15Generic approved under the new chemical-drug registration classificationCDE ↗
Montelukast Sodium Chewable TabletsShandong Dan Hong Pharmaceutical Co., Ltd. romanizedShandong Bu Zhang Pharmaceutical Co., Ltd. romanized国药准字H202493272024/11/15Generic approved under the new chemical-drug registration classificationCDE ↗
Levetiracetam extended-release tabletsShandong Dan Hong Pharmaceutical Co., Ltd. romanizedShaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized国药准字H202448262024/09/03Generic approved under the new chemical-drug registration classificationCDE ↗
Levetiracetam extended-release tabletsShandong Dan Hong Pharmaceutical Co., Ltd. romanizedShaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized国药准字H202448272024/09/03Generic approved under the new chemical-drug registration classificationCDE ↗
Ezetimibe TabletsShandong Dan Hong Pharmaceutical Co., Ltd. romanizedShandong Bu Zhang Pharmaceutical Co., Ltd. romanized国药准字H202437622024/05/21Generic approved under the new chemical-drug registration classificationCDE ↗
Dapoxetine Hydrochloride TabletsShandong Dan Hong Pharmaceutical Co., Ltd. romanizedShaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized国药准字H202346832023/12/26Generic approved under the new chemical-drug registration classificationCDE ↗
Dapoxetine Hydrochloride TabletsShandong Dan Hong Pharmaceutical Co., Ltd. romanizedShaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized国药准字H202346842023/12/26Generic approved under the new chemical-drug registration classificationCDE ↗
Pregabalin CapsulesShandong Dan Hong Pharmaceutical Co., Ltd. romanizedShandong Bu Zhang Pharmaceutical Co., Ltd. romanized国药准字H202340162023/08/08Generic approved under the new chemical-drug registration classificationCDE ↗
Pregabalin CapsulesShandong Dan Hong Pharmaceutical Co., Ltd. romanizedShandong Bu Zhang Pharmaceutical Co., Ltd. romanized国药准字H202340172023/08/08Generic approved under the new chemical-drug registration classificationCDE ↗
Omeprazole Sodium for InjectionShandong Dan Hong Pharmaceutical Co., Ltd. romanizedShandong Kang Ai Pharmaceutical Co., Ltd. romanized国药准字 H202236542022/09/14Generic approved under the new chemical-drug registration classificationCDE ↗
Desloratadine TabletsShandong Dan Hong Pharmaceutical Co., Ltd. romanizedShandong Bu Zhang Pharmaceutical Co., Ltd. romanized国药准字H202234192022/06/23Generic 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.