01 1Arene Lifesciences
02 1Chong Kun Dang Pharm
03 1Daewoong Pharmaceutical
04 1Kyongbo Pharmaceutical Co., Ltd
05 1Lunan Pharmaceutical
06 1MFC
07 1Nishchem International Pvt. Ltd
08 1Prudence Pharma Chem
09 1Smruthi Organics
01 1China
02 4India
03 4South Korea
01 1Inactive
02 8Blank
01 9Blank
01 9Blank
01 1WC-0158
02 8Blank
01 120110215-130-H-110-11(1)
02 120130531-131-H-247-09
03 120200310-131-H-361-12
04 120211215-131-H-399-12
05 5Blank
01 9Blank
01 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24174
Submission : 2010-08-07
Status : Inactive
Type : II
Date of Issue : 2021-01-25
Valid Till : 2024-01-24
Written Confirmation Number : WC-0158
Address of the Firm :
Registrant Name : Chong Kun Dang Co., Ltd.
Registration Date : 2016-02-24
Registration Number : 20110215-130-H-110-11(1)
Manufacturer Name : Chong Kun Dang Co., Ltd. @ Kyungbo Pharmaceutical Co., Ltd. @ [Manufacturer of the second method starting material (amlodipine)] Changzhou Ruiming Pharmaceutical Co. Ltd
Manufacturer Address : 797-48 Manghyang-ro, Seonggeo-eup, Seobuk-gu, Cheonan-si, Chungcheongnam-do @ 174 Silok-ro, Asan-si, Chungcheongnam-do @ [Manufacturer of the second method starting material (amlodipine)] #1558, Longjiang Bei Road, Chunjiang Town, New-North District, Changzhou, Jiangsu, China
Registrant Name : MFC Corporation
Registration Date : 2021-12-15
Registration Number : 20211215-131-H-399-12
Manufacturer Name : Prudence Pharma Chem, Inc. @Prudence Pharma Chem
Manufacturer Address : 35, Cheongwon Industrial Complex 7-gil, Mado-myeon, Hwaseong-si, Gyeonggi-do, Plot no. 7407, B/H Lyka labs., GIDC Industrial Estate, Ankleshwar 393 002. Dist. Bharuch, Gujarat, India.
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2020-03-10
Registration Number : 20200310-131-H-361-12
Manufacturer Name : Kyungbo Pharmaceutical Co. Ltd.@Changzhou Ruiming Pharmaceutical Co. Ltd.
Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do @No.1558 Longjiang Bei Road, Chunjiang Town, New-North District Changzhou China
Registrant Name : Daewoong Bio Co., Ltd.
Registration Date : 2013-05-31
Registration Number : 20130531-131-H-247-09
Manufacturer Name : Daewoong Bio Co., Ltd.
Manufacturer Address : (445-938) 29, Yakjedanji-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
12
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