KDMF (Korea Drug Master File) Approved Products & Companies
The One Pharmtech Co., Ltd.
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Product:
Topiramate
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Initial Registration:
2022-05-22
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Registration Number:
20130329-170-I-181-06(9)
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MFDS Classification:
Appendix 1
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Applicant:
The One Pharmtech Co., Ltd.
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Last Modified:
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Country:
India
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Status:
Active
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Manufacturer:
Sun Pharmaceutical Industries Ltd.
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Withdrawal Date:
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Final Annual Reporting Year:
-
Manufacturing Facility:
Plot No. 25, Phase -Ⅳ, GIDC Industrial Estate, Panoli -394 116, District Bharuch, Gujarat, India
The U Pharmaceutical Co., Ltd.
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Product:
Terbinafine hydrochloride
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Initial Registration:
2022-12-05
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Registration Number:
20190322-49-A-349-21(12)
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MFDS Classification:
Appendix 1
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Applicant:
The U Pharmaceutical Co., Ltd.
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Last Modified:
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Country:
china
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Status:
Active
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Manufacturer:
Zhejiang East-asia Pharmaceutical Co., Ltd. Ltd.
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Withdrawal Date:
-
Final Annual Reporting Year:
2025
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Manufacturing Facility:
Coastal Industrial City, Pubagang town, Sanmen county, Zhejiang, 317100, China
Toru Co., Ltd.
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Product:
Acetaminophen
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Initial Registration:
2016-02-16
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Registration Number:
20151015-32-C-350-20(6)
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MFDS Classification:
Appendix 1
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Applicant:
Toru Co., Ltd.
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Last Modified:
2020-04-24
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Country:
china
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Status:
Active
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Manufacturer:
Lianyungang Kangle Pharmaceutical Co.,Ltd,
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Withdrawal Date:
-
Final Annual Reporting Year:
-
Manufacturing Facility:
No.2, Huanan Road, Ganyu Economic Development Zone, China.
UK Chemipharm Co., Ltd.
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Product:
vancomycin hydrochloride
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Initial Registration:
2014-12-11
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Registration Number:
20130614-159-I-311-03(2)
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MFDS Classification:
Appendix 1
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Applicant:
UK Chemipharm Co., Ltd.
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Last Modified:
2021-12-24
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Country:
china
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Status:
Active
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Manufacturer:
Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory
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Withdrawal Date:
-
Final Annual Reporting Year:
-
Manufacturing Facility:
98 East Xinchang Dadao Road, Xinchang, Zhejiang, 312500 PRChina
Unimed Pharmaceutical Co., Ltd.
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Product:
Zahager X
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Initial Registration:
2007-07-23
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Registration Number:
20070723-01-HP-15-11
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MFDS Classification:
human placenta origin
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Applicant:
Unimed Pharmaceutical Co., Ltd.
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Last Modified:
2024-02-21
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Country:
korea
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Status:
Active
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Manufacturer:
Unimed Pharmaceutical Co., Ltd.
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Withdrawal Date:
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Final Annual Reporting Year:
2022
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Manufacturing Facility:
110-27 Silok-ro, Asan-si, Chungnam
Union Gas Co., Ltd.
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Product:
nitric oxide
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Initial Registration:
2021-07-05
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Registration Number:
351-1-ND
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MFDS Classification:
new substance
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Applicant:
Union Gas Co., Ltd.
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Last Modified:
2024-04-02
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Country:
-
Status:
Active
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Manufacturer:
Union Gas Co., Ltd. @ HK Materials
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Withdrawal Date:
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Final Annual Reporting Year:
-
Manufacturing Facility:
370-1, Wonam-ro, Namsa-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do @ 173-67, Daeheung 1-gil, Seongnam-myeon, Dongnam-gu, Cheonan-si, Chungcheongnam-do
UNU Generic Co., Ltd.
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Product:
Desvenlafaxine succinate monohydrate
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Initial Registration:
2021-11-30
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Registration Number:
Su827-2-ND
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MFDS Classification:
new substance
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Applicant:
UNU Generic Co., Ltd.
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Last Modified:
2023-11-15
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Country:
-
Status:
Active
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Manufacturer:
Lupin Manufacturing Solutions Limited@HIKAL LIMITED
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Withdrawal Date:
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Final Annual Reporting Year:
2024
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Manufacturing Facility:
Block No.21, Dabhasa Taluka Padra City : Dabhasa-391-440, Dist : Vadodara, Gujarat, state, India@Plot No. 72&82A, KIADB Industrial Area, Jigani, Anekal Taluk, Bangalore-560105, India
UNUST Co., Ltd.
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Product:
felodipine
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Initial Registration:
2005-08-31
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Registration Number:
20050831-69-B-181-03
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MFDS Classification:
Appendix 1
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Applicant:
UNUST Co., Ltd.
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Last Modified:
2010-02-17
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Country:
India
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Status:
Active
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Manufacturer:
Cipla Limited
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Withdrawal Date:
-
Final Annual Reporting Year:
2019
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Manufacturing Facility:
Virgonagar, Old Madras Road, Bangalore 560 049, India (Mumbai Central Mumbai 400 008 India)
V-On Bio Co., Ltd.
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Product:
Cinacalcet hydrochloride
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Initial Registration:
2020-06-05
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Registration Number:
Number 4579-5-ND(2)
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MFDS Classification:
new substance
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Applicant:
V-On Bio Co., Ltd.
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Last Modified:
-
Country:
India
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Status:
Active
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Manufacturer:
Solara Active Pharma Sciences Limited
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Withdrawal Date:
-
Final Annual Reporting Year:
-
Manufacturing Facility:
RS No.33 & 34 Mather Road, Periyakalapet, Puducherry-605014. India
Vinkorea
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Product:
sodium hyaluronate
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Initial Registration:
2026-02-13
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Registration Number:
20260213-96-E-194-70
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MFDS Classification:
Appendix 1
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Applicant:
Vinkorea
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Last Modified:
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Country:
china
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Status:
Active
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Manufacturer:
Bloomage Biotechnology Corp., Ltd.
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Withdrawal Date:
-
Final Annual Reporting Year:
-
Manufacturing Facility:
No 678, Tianchen St., High-Tech Development Zone, Jinan City, Shandong Province, PR of China
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