01 1BOC Sciences
02 2Ipca Laboratories
03 2Mangalam Drugs & Organics Ltd
04 1Sibbiotech
05 1Viatris
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01 4India
02 1Russia
03 2U.S.A
04 2Blank
01 2Active
02 2Inactive
03 5Blank
01 1Valid
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01 9Blank
01 1WC-0091
02 1WC-0105
03 1WC-0167
04 1WC-0473
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-07
Pay. Date : 2013-07-30
DMF Number : 25258
Submission : 2011-10-11
Status : Active
Type : II
Certificate Number : R0-CEP 2022-258 - Rev 00
Issue Date : 2023-06-23
Type : Chemical
Substance Number : 635
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-07-02
Written Confirmation Number : WC-0091
Address of the Firm :
NDC Package Code : 57451-1198
Start Marketing Date : 2012-06-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-16
Pay. Date : 2013-07-22
DMF Number : 27260
Submission : 2013-07-29
Status : Active
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 : 86
Submission : 1940-01-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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 : 8949
Submission : 1991-02-08
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Date of Issue : 2019-05-21
Valid Till : 2022-07-02
Written Confirmation Number : WC-0105
Address of the Firm :
NDC Package Code : 57451-1198
Start Marketing Date : 2012-06-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2020-06-11
Valid Till : 2023-06-10
Written Confirmation Number : WC-0473
Address of the Firm :
Date of Issue : 2022-10-27
Valid Till : 2025-07-22
Written Confirmation Number : WC-0167
Address of the Firm :
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