01 1Angels Pharma India Private Limited
02 1F.I.S. Fabbrica Italiana Sintetici
03 1HELM Portugal
04 1Hoventa Pharma
05 1MSN Laboratories
06 1Novartis Pharmaceuticals Corporation
07 1Olon S.p.A
08 1Refarmed Chemicals
09 1Shamrock Medicaments
10 1Shandong Boyuan Pharmaceutical
01 1China
02 4India
03 2Italy
04 1Portugal
05 2Switzerland
01 2Active
02 1Inactive
03 7Blank
01 10Blank
01 10Blank
01 1WC-0021n
02 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33058
Submission : 2019-06-18
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 : 27059
Submission : 2013-06-07
Status : Active
Type : II
Registrant Name : G-Therapeutics Korea Co., Ltd.
Registration Date : 2011-02-15
Registration Number : 20110215-49-A-244-16
Manufacturer Name : Novartis Ringaskiddy Limited
Manufacturer Address : Ringaskiddy, Co. Cork
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20266
Submission : 2007-01-29
Status : Inactive
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
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