01 1ALP Pharm
02 1Abbott Laboratories
03 1Alembic Pharmaceuticals Limited
04 1Alfasigma
05 1Cyalume Specialty Products
06 1Dupont
07 2F. Hoffmann-La Roche
08 1Formosa Laboratories
09 1Harman Finochem
10 1PCA - Prodotti Chimicie Alimentari S.p.A
11 1Solara Active Pharma Sciences
12 1Symed Labs
13 1Taro Pharmaceutical Industries
14 5Blank
01 1China
02 4India
03 2Italy
04 2Switzerland
05 1Taiwan
06 4U.S.A
07 5Blank
01 7Active
02 12Inactive
01 1Withdrawn by EDQM Failure to CEP procedure
02 18Blank
01 19Blank
01 1WC-0044
02 1WC-0072
03 1WC-0081
04 1WC-0127
05 15Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19680
Submission : 2006-08-07
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-08-04
Written Confirmation Number : WC-0127
Address of the Firm :
GDUFA
DMF Review : N/A
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DMF Number : 20674
Submission : 2007-07-13
Status : Active
Type : II
Certificate Number : R1-CEP 2009-322 - Rev 00
Issue Date : 2016-05-11
Type : Chemical
Substance Number : 407
Status : Withdrawn by EDQM F...
Date of Issue : 2022-06-06
Valid Till : 2025-07-21
Written Confirmation Number : WC-0044
Address of the Firm :
NDC Package Code : 66064-4001
Start Marketing Date : 2007-06-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
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DMF Number : 23284
Submission : 2009-12-09
Status : Active
Type : II
GDUFA
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DMF Number : 20465
Submission : 2007-04-23
Status : Active
Type : II
GDUFA
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Rev. Date :
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DMF Number : 19678
Submission : 2006-08-14
Status : Active
Type : II
Date of Issue : 2019-10-07
Valid Till : 2022-09-08
Written Confirmation Number : WC-0072
Address of the Firm :
NDC Package Code : 66022-0105
Start Marketing Date : 2008-02-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
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DMF Number : 4092
Submission : 1981-02-25
Status : Inactive
Type : II
GDUFA
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DMF Number : 3637
Submission : 1979-11-01
Status : Inactive
Type : II
GDUFA
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DMF Number : 3641
Submission : 1979-11-01
Status : Inactive
Type : II
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DMF Number : 482
Submission : 1962-04-26
Status : Inactive
Type : II
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DMF Number : 441
Submission : 1961-07-21
Status : Inactive
Type : II
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