01 1Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
02 1Esteve Quimica
03 1Gilead Sciences
04 1Grace
05 1Huzhou Zhanwang Pharmaceutical
06 1MLA Group
07 1Schwabe Pharma
08 1Yuhan Corporation
09 5Blank
01 6Active
02 7Blank
01 13Blank
01 1227MF10274
02 12Blank
01 13Blank
01 1Su6273-10-ND
02 1Su6273-11-ND
03 11Blank
01 153499-2911
02 168466-1977
03 187126-015
04 187126-016
05 9Blank
01 13Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37722
Submission : 2022-11-25
Status : Active
Type : IV
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 : 41027
Submission : 2024-12-30
Status : Active
Type : IV
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 : 41165
Submission : 2025-03-03
Status : Active
Type : IV
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37871
Submission : 2022-12-16
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34075
Submission : 2019-08-16
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 932
Submission : 1965-12-16
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 87126-016
Start Marketing Date : 2025-12-01
End Marketing Date : 2049-12-01
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Registration Number : 227MF10274
Registrant's Address : 1021 Hayter Road Edmonton, Alberta T6S 1A1, Canada
Initial Date of Registration : 2015-12-01
Latest Date of Registration :
Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2016-07-01
Registration Number : Su6273-11-ND
Manufacturer Name : Esteve Quimica, SA
Manufacturer Address : C/ Ter, 94 Polígon Industrial 17460 Celrà (Girona), Spain
Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2016-07-01
Registration Number : Su6273-10-ND
Manufacturer Name : Yuhan Chemical
Manufacturer Address : 45 Jiwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do
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