01 1Biotechnica DWC
02 1Cambrex Corporation
03 1Centaur Pharmaceuticals
04 1F.I.S. Fabbrica Italiana Sintetici
05 1Industriale Chimica
06 1Kalintis Healthcare
07 1R L Fine Chem
08 1Sandoz B2B
09 1Teva API
10 2Blank
01 1Algeria
02 3India
03 1Israel
04 2Italy
05 1Switzerland
06 1U.S.A
07 2Blank
01 5Active
02 4Inactive
03 2Blank
01 2Valid
02 9Blank
01 11Blank
01 1WC-0107
02 10Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-01-19
Pay. Date : 2022-11-30
DMF Number : 36730
Submission : 2022-12-10
Status : Active
Type : II
NDC Package Code : 72166-009
Start Marketing Date : 2020-08-08
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 : 40432
Submission : 2024-08-28
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4438
Submission : 1982-02-18
Status : Active
Type : II
NDC Package Code : 12828-0024
Start Marketing Date : 1986-05-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-25
Pay. Date : 2014-04-25
DMF Number : 22060
Submission : 2008-09-30
Status : Active
Type : II
Certificate Number : CEP 2008-283 - Rev 02
Issue Date : 2023-10-19
Type : Chemical
Substance Number : 778
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-06-25
Written Confirmation Number : WC-0107
Address of the Firm :
NDC Package Code : 64330-015
Start Marketing Date : 2008-09-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5208
Submission : 1984-01-09
Status : Active
Type : II
Certificate Number : CEP 2011-014 - Rev 02
Issue Date : 2024-06-19
Type : Chemical
Substance Number : 778
Status : Valid
NDC Package Code : 48087-0087
Start Marketing Date : 2010-04-12
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 : 5268
Submission : 1983-10-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4939
Submission : 1983-01-21
Status : Inactive
Type : II
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 : 6445
Submission : 1986-06-27
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18115
Submission : 2005-02-25
Status : Inactive
Type : II
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