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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18051
Submission : 2005-02-02
Status : Active
Type : II
CEP/COS
Certificate Numbers : R1-CEP 2002-143 - Rev 02
Status : Valid
Issue Date : 2022-11-07
Type : Chemical
Substance Number : 182
CEP/COS
Certificate Numbers : R1-CEP 2002-035 - Rev 03
Status : Valid
Issue Date : 2023-03-13
Type : Chemical
Substance Number : 199
Certificate Numbers : R1-CEP 2009-053 - Rev 02
Status : Valid
Issue Date : 2023-03-13
Type : Chemical
Substance Number : 199
CEP/COS
Certificate Numbers : R1-CEP 2002-118 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2009-05-12
Type : Chemical
Substance Number : 198
NDC Package Code : 60264-310
Start Marketing Date : 2007-05-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 60264-115
Start Marketing Date : 2004-09-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 60264-110
Start Marketing Date : 2003-10-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Inspections and registrations
District Decision : No Action Indicated
Inspection End Date : 2012-08-02
City : Chifeng
State :
Country/Area : CN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2012-08-02
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-10-16
City : Chifeng
State :
Country/Area : CN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-10-16
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-10-16
City : Chifeng
State :
Country/Area : CN
Zip :
District : ORA
Center : CVM
Project Area : Monitoring of Marketed Animal Dr...
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-10-16
API Manufacturer : API MANUFACTURE
FDF Manufacturer :
Facility Name : Chifeng Pharmaceutical Co., Lt...
Business Address : 84, Yidong Street, Hongshan ...
FEI Number : 1000390117
Country : China
Paid in : 2019
ABOUT THIS PAGE
Shanghai Hegno Pharmaceutical is a supplier offers 3 products (APIs, Excipients or Intermediates).
Find a price of Griseofulvin bulk with DMF, CEP offered by Shanghai Hegno Pharmaceutical
Find a price of Oxytetracycline Dihydrate bulk with CEP offered by Shanghai Hegno Pharmaceutical
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