Aspen API. More than just an API.
01 1Aspen API
02 1Symbiotec Pharmalab
03 1CHEMO
04 1Fujifilm Diosynth Biotechnologies
05 1Guangzhou Topwork Chemical
06 1Industriale Chimica
07 2Monachem
08 1NEWCHEM SPA
09 2Sterling Spa
10 1Swati Spentose
11 1Teva API
12 2Teva Pharmaceutical Industries
13 1Unipex
01 1China
02 1France
03 2India
04 3Israel
05 4Italy
06 2Monaco
07 1Netherlands
08 1Spain
09 1United Kingdom
01 4Active
02 3Inactive
03 9Blank
01 5Valid
02 2Withdrawn by Holder
03 9Blank
01 16Blank
01 16Blank
Aspen API. More than just an API.
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36055
Submission : 2021-06-25
Status : Active
Type : II
Certificate Number : R1-CEP 2015-266 - Rev 01
Issue Date : 2021-12-20
Type : Chemical
Substance Number : 1551
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23921
Submission : 2010-06-25
Status : Active
Type : II
Certificate Number : R1-CEP 2010-179 - Rev 00
Issue Date : 2016-11-10
Type : Chemical
Substance Number : 1551
Status : Valid
NDC Package Code : 64918-1002
Start Marketing Date : 2011-11-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28125
Submission : 2014-03-17
Status : Active
Type : II
Certificate Number : R0-CEP 2019-241 - Rev 01
Issue Date : 2020-03-17
Type : Chemical
Substance Number : 1551
Status : Withdrawn by Holder
NDC Package Code : 64918-1002
Start Marketing Date : 2011-11-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17534
Submission : 2004-07-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22750
Submission : 2009-04-18
Status : Inactive
Type : II
Certificate Number : R0-CEP 2020-084 - Rev 01
Issue Date : 2023-07-24
Type : Chemical
Substance Number : 1551
Status : Valid
NDC Package Code : 24002-0013
Start Marketing Date : 2009-08-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9232
Submission : 1991-08-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13987
Submission : 1999-02-17
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-221 - Rev 04
Issue Date : 2016-12-13
Type : Chemical
Substance Number : 1551
Status : Withdrawn by Holder
Certificate Number : CEP 2014-178 - Rev 05
Issue Date : 2024-09-25
Type : Chemical
Substance Number : 1551
Status : Valid
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