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01 1Jai Radhe Sales
02 1HRV Global Life Sciences
03 1Almirall
04 1Apotex Pharmachem
05 1CHEMO
06 1Integrin Life Sciences
07 2MSN Laboratories
08 1Orchid Pharma
09 1SMS Pharmaceuticals
10 1Synergene Active Ingredients Pvt Ltd
11 1Tecoland Corporation
12 2Viatris
01 1Canada
02 8India
03 2Spain
04 3U.S.A
01 4Active
02 2Inactive
03 8Blank
01 1Valid
02 13Blank
01 14Blank
01 1WC-0021
02 1WC-0021n
03 1WC-0071
04 1WC-0117
05 1WC117Amendment
06 9Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-08
Pay. Date : 2012-11-06
DMF Number : 20424
Submission : 2007-03-22
Status : Active
Type : II
Date of Issue : 2022-06-22
Valid Till : 2025-07-28
Written Confirmation Number : WC-0117
Address of the Firm :
NDC Package Code : 65015-673
Start Marketing Date : 2015-01-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-31
Pay. Date : 2013-01-08
DMF Number : 18962
Submission : 2005-11-18
Status : Active
Type : II
Date of Issue : 2019-06-26
Valid Till : 2022-07-02
Written Confirmation Number : WC-0071
Address of the Firm :
NDC Package Code : 67835-5003
Start Marketing Date : 2008-02-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-03-09
Pay. Date : 2021-02-02
DMF Number : 25327
Submission : 2011-09-24
Status : Active
Type : II
Certificate Number : R0-CEP 2020-253 - Rev 00
Issue Date : 2022-01-25
Type : Chemical
Substance Number : 2970
Status : Valid
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
NDC Package Code : 14501-0073
Start Marketing Date : 2011-08-24
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 : 25225
Submission : 2011-08-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12475
Submission : 1997-04-17
Status : Inactive
Type : II
Date of Issue : 2019-08-13
Valid Till : 2021-08-12
Written Confirmation Number : WC117Amendment
Address of the Firm :
NDC Package Code : 65015-673
Start Marketing Date : 2015-01-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0021
Address of the Firm :
NDC Package Code : 14501-0073
Start Marketing Date : 2011-08-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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