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27-30 April, 2026
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27-29 April, 2026
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27631
Submission : 2013-07-19
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25958
Submission : 2012-03-01
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43353
Submission : 2026-02-13
Status : Active
Type : II

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Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2026-04-16
Registration Number : 20260416-94-E-196-20
Manufacturer Name : Hunan Yuxin Pharmaceutical Co....
Manufacturer Address : Longxutang, Shuangqing District, Shaoyang City, Hunan Province, China

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Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2025-05-19
Registration Number : 20250519-94-E-187-15
Manufacturer Name : Hunan Yuxin Pharmaceutical Co....
Manufacturer Address : Longxutang, Shuangqing District Shaoyang City Hunan Province, China

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Inspections and registrations
District Decision : Voluntary Action Indicated
Inspection End Date : 2024-07-12
City : Shaoyang
State :
Country/Area : China
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2024-07-12

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Country : China
City/Region : Shaoyang
Audit Date : Apr-24
Audit Type : On-Site
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
Hunan Yuxin Pharmaceutical is a supplier offers 4 products (APIs, Excipients or Intermediates).
Find Prednisolone bulk with DMF offered by Hunan Yuxin Pharmaceutical
Find CHEMICAL INTERMEDIATE-16A-HYDROXY PREDNISOLONE bulk with DMF offered by Hunan Yuxin Pharmaceutical
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