01 1Eli Lilly
02 1Fermenta Biotech Limited
03 1Green Stone Swiss Co ., Ltd
04 1Macleods Pharmaceuticals Limited
05 1ST Pharma
06 1Saurav Chemicals
07 1Solara Active Pharma Sciences
08 3Blank
01 1China
02 4India
03 1South Korea
04 1U.S.A
05 3Blank
01 2Active
02 5Inactive
03 3Blank
01 10Blank
01 10Blank
01 1WC-0127
02 1WC-0171
03 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21720
Submission : 2008-06-20
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-08-04
Written Confirmation Number : WC-0127
Address of the Firm :
NDC Package Code : 72643-027
Start Marketing Date : 2021-11-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-15
Pay. Date : 2016-09-21
DMF Number : 30598
Submission : 2016-08-03
Status : Active
Type : II
NDC Package Code : 33342-600
Start Marketing Date : 2023-08-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (0.5kg/.5kg)
Marketing Category : BULK INGREDIENT
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 : 13317
Submission : 1998-09-01
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 : 13416
Submission : 1998-09-01
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 : 13660
Submission : 1998-09-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13686
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13571
Submission : 1998-09-01
Status : Inactive
Type : II
Date of Issue : 2019-08-13
Valid Till : 2022-08-12
Written Confirmation Number : WC-0171
Address of the Firm :
Registrant Name : Estifarm Co., Ltd.
Registration Date : 2022-10-14
Registration Number : 20221014-209-J-1379
Manufacturer Name : Estifarm Co., Ltd.
Manufacturer Address : 231, Hyeop-ro, Siheung-si, Gyeonggi-do
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