KDMF (Korea Drug Master File) Approved Products & Companies
Kyungbo Pharmaceutical Co., Ltd.
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Product:
Cefpodoxime proxetil
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Initial Registration:
2005-08-31
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Registration Number:
20050831-25-A-47-02
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MFDS Classification:
Appendix 1
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Applicant:
Kyungbo Pharmaceutical Co., Ltd.
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Last Modified:
2024-04-09
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Country:
-
Status:
Active
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Manufacturer:
Kyungbo Pharmaceutical Co., Ltd. @ M/s Pure and Cure Healthcare Private Limited
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Withdrawal Date:
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Final Annual Reporting Year:
2024
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Manufacturing Facility:
174 Silok-ro, Asan-si, Chungcheongnam-do @ Village Sundhran, Post office Mubarikpur, Derabassi, District Sahibzada Ajit Singh Nagar, Punjab, India
Kyungdong Pharmaceutical Co., Ltd.
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Product:
Risperidon
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Initial Registration:
2005-08-31
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Registration Number:
20050831-10-C-80-04
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MFDS Classification:
Appendix 1
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Applicant:
Kyungdong Pharmaceutical Co., Ltd.
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Last Modified:
2024-02-13
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Country:
korea
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Status:
Withdrawal
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Manufacturer:
Kyungdong Pharmaceutical Co., Ltd.
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Withdrawal Date:
2024-02-13
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Final Annual Reporting Year:
2014
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Manufacturing Facility:
224-3, Jeyakdanji-ro, Yanggam-myeon, Hwaseong-si, Gyeonggi-do
Kyungjin Pharmaceutical
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Product:
Naproxen sodium
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Initial Registration:
2015-09-18
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Registration Number:
20130204-143-I-170-06(8)
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MFDS Classification:
Appendix 1
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Applicant:
Kyungjin Pharmaceutical
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Last Modified:
2023-11-17
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Country:
china
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Status:
Withdrawal
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Manufacturer:
Zhejiang Tianxin Pharmaceutical Co., Ltd.
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Withdrawal Date:
2023-11-17
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Final Annual Reporting Year:
-
Manufacturing Facility:
215 Fengze Road, Tiantai Zhejiang 317200
Kyungnam Pharmaceutical Co., Ltd.
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Product:
Ziziphus jujuba hydrolysate
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Initial Registration:
2006-12-28
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Registration Number:
20061228-01-HP-5-03
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MFDS Classification:
human placenta origin
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Applicant:
Kyungnam Pharmaceutical Co., Ltd.
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Last Modified:
2012-01-10
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Country:
korea
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Status:
Active
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Manufacturer:
Kyungnam Pharmaceutical Co., Ltd.
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Withdrawal Date:
-
Final Annual Reporting Year:
2020
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Manufacturing Facility:
79, Guryong-ro 4nam-gil, Uiryeong-eup, Uiryeong-gun, Gyeongsangnam-do
L Bioscience Co., Ltd.
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Product:
Topiramate
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Initial Registration:
2025-03-24
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Registration Number:
20250324-170-I-705-21
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MFDS Classification:
Appendix 1
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Applicant:
L Bioscience Co., Ltd.
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Last Modified:
-
Country:
India
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Status:
Active
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Manufacturer:
MSN Organics Private Limited
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Withdrawal Date:
-
Final Annual Reporting Year:
-
Manufacturing Facility:
Sy. No. 224/A, Bibinagar (Village), Bibinagar (Mandal), Yadadri Bhuvanagiri District, Pincode 508 126, Telangana, India
Leaders Bio Co., Ltd.
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Product:
Clarithromycin
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Initial Registration:
2014-07-25
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Registration Number:
20110630-62-A-247-18(6)
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MFDS Classification:
Appendix 1
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Applicant:
Leaders Bio Co., Ltd.
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Last Modified:
2024-04-29
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Country:
-
Status:
Active
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Manufacturer:
Zhejiang Better Pharmaceuticals Co., Ltd. @ [Manufacturer of Starting Material (Erythromycin thiocyanate)] HEC Pharm Co., Ltd. @ [Manufacturer of Starting Material (Erythromycin thiocyanate)] Yili Chuanning Biotechnology Co., Ltd.
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Withdrawal Date:
-
Final Annual Reporting Year:
2025
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Manufacturing Facility:
Sanjiang Road, Paojiang Industrial Zone, Yuecheng District, Shaoxing, Zhejiang, PR China@No.3 Industrial Park of HEC, Yidu City, Hubei Province, PRChina@No.1, Gongchen Road, Yining Park, Khorgos Economic Development Zone, Yili Kazak Autonomous Prefecture, Xinjiang, PR China
Lee Sung International Co., Ltd.
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Product:
Itraconazole
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Initial Registration:
2007-09-28
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Registration Number:
20070928-56-A-196-14
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MFDS Classification:
Appendix 1
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Applicant:
Lee Sung International Co., Ltd.
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Last Modified:
2023-03-24
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Country:
-
Status:
Active
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Manufacturer:
Nosch Lab. PVT.LTD@Nosch Labs Pvt. Ltd (Unit IV)
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Withdrawal Date:
-
Final Annual Reporting Year:
2014
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Manufacturing Facility:
5-5-35/33/3, Prasanthinagar, IDA, Kukatpally, Hyderabad-500 072@Sy. No. 332, 333 & 335, Veliminedu Village, Chityal Mandal, Nalgonda District-508114, Telangana, India
Lee Yeon Pharmaceutical Co., Ltd.
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Product:
Metformin hydrochloride
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Initial Registration:
2005-08-31
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Registration Number:
20050831-37-C-38-06
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MFDS Classification:
Appendix 1
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Applicant:
Lee Yeon Pharmaceutical Co., Ltd.
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Last Modified:
-
Country:
korea
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Status:
Active
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Manufacturer:
Lee Yeon Pharmaceutical Co., Ltd.
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Withdrawal Date:
-
Final Annual Reporting Year:
2025
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Manufacturing Facility:
69-10 Hansam-ro, Deoksan-eup, Jincheon-gun, Chungcheongbuk-do
Leo Pharma Ltd.
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Product:
Ingenol mebutate
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Initial Registration:
2013-10-29
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Registration Number:
Su4726-1-ND
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MFDS Classification:
new substance
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Applicant:
Leo Pharma Ltd.
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Last Modified:
2024-03-08
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Country:
australia
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Status:
Withdrawal
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Manufacturer:
LEO Pharma Southport Pty Ltd
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Withdrawal Date:
2024-03-08
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Final Annual Reporting Year:
-
Manufacturing Facility:
18 Olympic Circuit & 5 Goodyear Street, Southport, Queensland 4215, Australia
LG Chem Corp.
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Product:
sodium hyaluronate
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Initial Registration:
2007-09-28
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Registration Number:
20070928-96-E-17-03
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MFDS Classification:
Appendix 1
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Applicant:
LG Chem Corp.
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Last Modified:
2024-03-04
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Country:
korea
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Status:
Active
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Manufacturer:
LG Chem Corp.
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Withdrawal Date:
-
Final Annual Reporting Year:
2025
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Manufacturing Facility:
129 Seokam-ro, Iksan-si, Jeonbuk Special Self-Governing Province
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