01 1Aurore Life Sciences
02 2Cheer Fine Pharmaceutical
03 2Daiwa Pharmaceuticals
04 1DongWha Pharm
05 1DongWoo Syntech
06 1Epoch Labs
07 3Estechpharma
08 1Fuan Pharmaceutical
09 1Guangzhou Tosun Pharmaceutical
10 1Hetero Drugs
11 3Jiangxi Synergy Pharmaceutical
12 1Nissei Corporation
13 1Otsuka Chemical Co Ltd
14 1R L Fine Chem
15 1Sam-Oh Pharm Co. Ltd
16 1Saurav Chemicals
17 1Shasun Chemicals and Drugs Ltd
18 2Suzhou Tianma Pharma Group Co Ltd
19 2Zhejiang Liaoyuan Pharmaceutical Co LTD
01 11China
02 8India
03 2Japan
04 6South Korea
01 2Inactive
02 25Blank
01 27Blank
01 1218MF10724
02 1218MF10732
03 1218MF10849
04 1218MF10919
05 1220MF10002
06 1221MF10056
07 1222MF10036
08 1222MF10056
09 1222MF10140
10 1222MF10239
11 1222MF10259
12 1223MF10143
13 1224MF10078
14 1224MF10123
15 1227MF10124
16 1228MF10089
17 1229MF10024
18 1229MF10220
19 1230MF10081
20 1305MF10002
21 7Blank
01 1WC-0171
02 26Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15001
Submission : 2000-08-10
Status : Inactive
Type : II
Registration Number : 218MF10919
Registrant's Address : 5, Soonwha-dong, Joong-Ku, Seoul. Korea
Initial Date of Registration : 2006-11-21
Latest Date of Registration : --
Registrant Name : Dongwha Pharmaceutical Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-4-B-21-09
Manufacturer Name : Dongwha Pharmaceutical Co., Ltd.
Manufacturer Address : 167, Chungju Industrial Complex 1-ro, Chungchu-si, Chungcheongbuk-do
Registration Number : 222MF10259
Registrant's Address : 25, Barangongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do Korea
Initial Date of Registration : 2010-11-18
Latest Date of Registration : --
Registrant Name : Polaris AI Pharma Co., Ltd.
Registration Date : 2012-09-27
Registration Number : 20120927-4-B-353-19
Manufacturer Name : Polaris AI Pharma Co., Ltd.
Manufacturer Address : 25 Balan Industrial Complex-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, 34 Block 10-11, Balan Industrial Complex
Registration Number : 229MF10220
Registrant's Address : Plot No. 370, Industrial Area, Phase-II, Panchkula, Haryana State, India
Initial Date of Registration : 2017-12-18
Latest Date of Registration : --
Date of Issue : 2019-08-13
Valid Till : 2022-08-12
Written Confirmation Number : WC-0171
Address of the Firm :
Registration Number : 229MF10024
Registrant's Address : No. 2066 Tangkou Road, Economy and Technology Development Zone, Hefei, Anhui Province, China
Initial Date of Registration : 2017-01-31
Latest Date of Registration : --
Registration Number : 230MF10081
Registrant's Address : Zhejiang Provincial Chemical and Medical Raw Material Base Linhai Zone Duqiao town, Linhai City, Zhejiang Provin ce, China
Initial Date of Registration : 2018-07-09
Latest Date of Registration : --
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2021-01-07
Registration Number : 20210107-4-B-439-22
Manufacturer Name : Zhejiang Liaoyuan Pharmaceutical Co., Ltd.
Manufacturer Address : Zhejiang Provincial Chemical and Medical Raw Material Base Linhai Zone, Duqiao Town, Linhai City, Zhejiang Province, 317016, China
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