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 1PRG Pharma
11 1Quimica Sintetica
12 1Raks Pharma
13 1Zhejiang Huahai Pharmaceutical
14 1Zydus Lifesciences
01 1China
02 11India
03 3Italy
04 1Spain
01 9Active
02 1Inactive
03 6Blank
01 16Blank
01 16Blank
01 1WC-0022
02 1WC-0107
03 1WC-0135A
04 1WC-0383A4
05 12Blank
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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 : 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 : 2017-04-17
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 : 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 : 2017-05-18
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 : 2016-05-24
Pay. Date : 2015-09-29
DMF Number : 29733
Submission : 2015-09-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
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 : 2017-05-17
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
Address of the Firm :
Date of Issue : 2019-12-03
Valid Till : 2022-07-21
Written Confirmation Number : WC-0135A
Address of the Firm :
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