01 2COSMA S.p.A
02 1Centaur Pharmaceuticals
03 1DEAFARMA
04 1Dishman Carbogen Amcis
05 1Glenmark Pharmaceuticals
06 1Hetero Drugs
07 2MSN Laboratories
08 1Maiden Group
09 1Micro Labs Limited
10 1Olon S.p.A
11 1PRG Pharma
12 1Quimica Sintetica
13 1Raks Pharma
14 1Zhejiang Huahai Pharmaceutical
15 1Zydus Lifesciences
01 1China
02 11India
03 4Italy
04 1Spain
01 9Active
02 1Inactive
03 7Blank
01 17Blank
01 17Blank
01 1WC-0022
02 1WC-0107
03 1WC-0135A
04 1WC-0383A4
05 13Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2017-04-19
Pay. Date : 2017-03-06
DMF Number : 31223
Submission : 2016-12-31
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-01-22
Pay. Date : 2015-09-25
DMF Number : 29774
Submission : 2015-09-24
Status : Active
Type : II
NDC Package Code : 64220-190
Start Marketing Date : 2024-08-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-04-17
Pay. Date : 2017-03-03
DMF Number : 31347
Submission : 2017-02-17
Status : Active
Type : II
NDC Package Code : 53069-1090
Start Marketing Date : 2013-07-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-07
Pay. Date : 2014-03-28
DMF Number : 28015
Submission : 2014-04-10
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-05-18
Pay. Date : 2017-02-02
DMF Number : 31327
Submission : 2017-03-16
Status : Active
Type : II
NDC Package Code : 51604-1183
Start Marketing Date : 2018-11-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-05-17
Pay. Date : 2017-04-27
DMF Number : 31699
Submission : 2017-04-28
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-06-25
Written Confirmation Number : WC-0107
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GDUFA
DMF Review : Reviewed
Rev. Date : 2016-05-24
Pay. Date : 2015-09-29
DMF Number : 29733
Submission : 2015-09-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 33095
Submission : 2018-08-16
Status : Active
Type : II
NDC Package Code : 68554-0115
Start Marketing Date : 2013-07-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-01-19
Pay. Date : 2016-09-29
DMF Number : 30891
Submission : 2016-09-21
Status : Active
Type : II
Date of Issue : 2019-10-15
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383A4
Address of the Firm :
NDC Package Code : 50370-0043
Start Marketing Date : 2014-03-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 28016
Submission : 2014-03-07
Status : Inactive
Type : II
Date of Issue : 2019-08-16
Valid Till : 2025-08-15
Written Confirmation Number : WC-0022
Address of the Firm :
NDC Package Code : 50370-0043
Start Marketing Date : 2014-03-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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