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List of Drug Master Files (KDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Fdc Limited to the Review Authority in Korea.

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01 Dorzolamide hydrochloride (2)

02 Flurbiprofen (1)

03 Rupatadine fumarate (2)

04 Timolol Maleate (1)

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01 Classia Co., Ltd. (2)

02 Kookjeon Pharmaceutical Co., Ltd. (3)

03 Leaders Bio Co., Ltd. (1)

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01 FDC Limited (6)

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01 India (6)

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Kookjeon Pharmaceutical Co., Ltd.
2022-01-21
20210629-209-J-843(A)
FDC Limited
India
Plot No. 19 & 20/2, MIDC,...
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Classia Co., Ltd.
2021-06-29
20210629-209-J-843
FDC Limited
India
Plot No. 19 & 20/2, MIDC,...
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Leaders Bio Co., Ltd.
2021-03-12
20210312-209-J-872
FDC Limited
India
Plot No. 19 & 20/2, MIDC,...
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Classia Co., Ltd.
2021-07-23
Wed173-28-ND(1)
FDC Limited
India
Plot No. 19 & 20/2, MIDC,...
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Kookjeon Pharmaceutical Co., Ltd.
2020-10-19
Wed173-28-ND
FDC Limited
India
Plot No. 19 & 20/2, MIDC,...
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Kookjeon Pharmaceutical Co., Ltd.
2013-11-19
20131119-201-I-286-08
FDC Limited
India
Plot No. 19 & 20/2, MIDC,...
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