01 1Glochem Industries
02 1Guangzhou Tosun Pharmaceutical
03 2Smruthi Organics
04 1Unichem Laboratories Limited
05 1Unipex
06 1Xian Libang Pharmaceutical Co.,Ltd
01 2China
02 1France
03 4India
01 1Inactive
02 6Blank
01 7Blank
01 7Blank
01 1WC-0013
02 1WC-0063
03 1WC-0158
04 1WC-0158A3-A4-A5
05 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17130
Submission : 2004-01-23
Status : Inactive
Type : II
Date of Issue : 2019-09-11
Valid Till : 2022-09-10
Written Confirmation Number : WC-0013
Address of the Firm :
Registrant Name : Dongwha Pharmaceutical Co., Ltd.
Registration Date : 2011-06-30
Registration Number : 20110630-130-H-139-30
Manufacturer Name : Glochem Industries Private Limited
Manufacturer Address : Survey Nos. 174 to 176, IDA Bollaram, Jinnaram Mandal, Sangareddy District-502 325, Telangana State, India
Date of Issue : 2022-06-30
Valid Till : 2025-07-28
Written Confirmation Number : WC-0063
Address of the Firm :
Registrant Name : Kolon Pharmaceutical Co., Ltd.
Registration Date : 2011-10-21
Registration Number : 20110414-130-H-48-19(4)
Manufacturer Name : Unichem Laboratories Ltd.Unichem Laboratories Ltd.@[Starting Material (Phthaloyl Amlodipine) Manufacturing Plant①] Abhinandan Rasayan Pvt.@[Starting Material (Phthaloyl Amlodipine) Manufacturing Plant②] Unichem Laboratories Limited
Manufacturer Address : Plot No.99, MIDC Area, Dhatav-Roha, Dist. Raigad-402 116, Maharashtra@Plot No. J-54. MIDC. Taloja, Dist Raigad, Maharashtra, India@Plot No. 197, Sector-1, Pithampur, Dist. Dhar (M.P.), India
Date of Issue : 2021-01-25
Valid Till : 2024-01-24
Written Confirmation Number : WC-0158
Address of the Firm :
Date of Issue : 2022-05-11
Valid Till : 2024-01-24
Written Confirmation Number : WC-0158A3-A4-A5
Address of the Firm :
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