01 1Chemische Fabrik Berg
02 1Moehs Iberica
03 1HRV Global Life Sciences
04 1Alkaloida Chemical Company Zrt
05 1Biotechnica DWC
06 1DMFs Not Supported
07 1F. Hoffmann-La Roche
08 2Harman Finochem
09 1JPN Pharma
10 1Nantong Jinghua Pharmaceutical
11 1Shandong Xinhua Pharmaceutical
12 2Siegfried AG
13 1Sms Lifesciences
14 10Yashiro Pharmaceutical Co Ltd
15 2Blank
01 1Algeria
02 2China
03 1Germany
04 1Hungary
05 5India
06 1Spain
07 3Switzerland
08 13Blank
01 6Active
02 4Inactive
03 17Blank
01 6Valid
02 21Blank
01 1218MF10249
02 1218MF10250
03 1218MF10251
04 1218MF10252
05 1218MF10253
06 1225MF10074
07 1225MF10075
08 1225MF10076
09 1225MF10077
10 1225MF10078
11 17Blank
01 1WC-0044
02 1WC-0045nA2
03 1WC-0336A3
04 24Blank
Certificate Number : CEP 2022-432 - Rev 00
Issue Date : 2023-11-09
Type : Chemical
Substance Number : 201
Status : Valid
NDC Package Code : 65319-1450
Start Marketing Date : 2019-01-14
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 : 17823
Submission : 2004-11-10
Status : Active
Type : II
Certificate Number : CEP 2003-017 - Rev 04
Issue Date : 2024-08-22
Type : Chemical
Substance Number : 201
Status : Valid
Date of Issue : 2022-06-06
Valid Till : 2025-07-21
Written Confirmation Number : WC-0044
Address of the Firm :
NDC Package Code : 66064-2001
Start Marketing Date : 2005-01-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31321
Submission : 2017-02-09
Status : Active
Type : II
Certificate Number : R1-CEP 2005-118 - Rev 02
Issue Date : 2016-10-04
Type : Chemical
Substance Number : 201
Status : Valid
NDC Package Code : 59348-0011
Start Marketing Date : 2015-11-02
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 : 27827
Submission : 2013-12-01
Status : Active
Type : II
Certificate Number : CEP 2017-269 - Rev 01
Issue Date : 2023-11-03
Type : Chemical
Substance Number : 201
Status : Valid
NDC Package Code : 58624-0520
Start Marketing Date : 1997-01-01
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 : 1049
Submission : 1967-03-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1169
Submission : 1968-04-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3756
Submission : 1980-02-28
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 : 778
Submission : 1964-01-24
Status : Inactive
Type : II
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