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List of Drug Master Files (KDMF) for Duloxetine Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Evonik Corporation (1)

02 Moehs Cantabra SL_x000D_ (1)

03 Alembic Pharmaceuticals Limited (1)

04 Asia Chemical Industries Ltd. (1)

05 Dasan Pharmaceutical Co., Ltd. @[Manufacturer of starting material 'duloxetine hydrochloride'] SCI Pharmtech, Inc. (1)

06 Hanseochem Co., Ltd. (1)

07 Hetero Drugs Limited (2)

08 Hetero Drugs Limited. (1)

09 Ildong Pharmaceutical Co., Ltd. (1)

10 Inist ST Co., Ltd. (1)

11 Korea Biochem Pharmaceutical Co., Ltd. (1)

12 Kyungbo Pharmaceutical Co., Ltd. (1)

13 Lilly del Caribe, Inc. (1)

14 MSN Laboratories PVT LTD (1)

15 Macleods Pharmaceuticals Limited (2)

16 Nosch Labs Pvt. Ltd@[Manufacturer of starting material (duloxetine hydrochloride)] Nosch Labs Pvt. Ltd (4)

17 Nosch Labs private limited Unit-II (1)

18 SCI Pharmtech, Inc. (1)

19 Shodhana Laboratories Limited (1)

20 Union Quimico Farmaceutica, SA (1)

21 [Starting material (duloxetine hydrochloride) manufacturer] Nosch Labs Pvt. Ltd@Nosch Labs Pvt. Ltd (1)

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01 Aging Life Science Co., Ltd. (1)

02 Dasan Pharmaceutical Co., Ltd. (1)

03 Hanseochem Co., Ltd. (1)

04 Hwanin Pharmaceutical Co., Ltd. (1)

05 Iksoo Pharmaceutical Co., Ltd. (1)

06 Ildong Pharmaceutical Co., Ltd. (1)

07 Inist ST Co., Ltd. (1)

08 Kookjeon Pharmaceutical Co., Ltd. (1)

09 Korea Biochem Pharmaceutical Co., Ltd. (1)

10 Korea Lily Co., Ltd. (2)

11 Korea Pharmaceutical Co., Ltd. (1)

12 Kyungbo Pharmaceutical Co., Ltd. (1)

13 Myungin Pharmaceutical Co., Ltd. (2)

14 Pharmapia Co., Ltd. (2)

15 Saehan Pharmaceutical Co., Ltd. (1)

16 Samo Pharmaceutical Co., Ltd. (1)

17 Sandoz Korea Co., Ltd. (1)

18 Sungjin Exim Co., Ltd. (1)

19 UNUST Co., Ltd. (1)

20 Unimed Pharmaceutical Co., Ltd. (1)

21 Wonpoong Pharmaceutical Co., Ltd. (3)

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01 Duloxetine hydrochloride (2)

02 duloxetine hydrochloride (24)

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01 Germany (1)

02 India (14)

03 Israel (1)

04 South Korea (6)

05 Spain (2)

06 Taiwan (1)

07 U.S.A (1)

URL Supplier Web Content
Korea Lily Co., Ltd.
2007-01-25
Number 51-3-ND
Evonik Corporation
U.S.A
Tippecanoe Laboratories16...
Saehan Pharmaceutical Co., Ltd.
2015-07-27
Number 4098-3-ND
Moehs Cantabra SL_x000D_
Spain
Poligono Industrial Reque...
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Sandoz Korea Co., Ltd.
2016-01-14
Number 4480-1-ND
Alembic Pharmaceuticals L...
India
Plot No. 842-843, TAL-Pad...
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Myungin Pharmaceutical Co., Ltd.
2018-01-16
Number 3838-4-ND(2)
Hetero Drugs Limited
India
Sy. No.213. 214&255, Bont...
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Inist ST Co., Ltd.
2014-10-08
2220-5-ND
Inist ST Co., Ltd.
South Korea
500 Sinnae-ro, Geumwang-e...
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Korea Biochem Pharmaceutical Co., Ltd.
2018-06-27
2152-5-ND
Korea Biochem Pharmaceuti...
South Korea
204 Sandan-gil, Jeonui-my...
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Kyungbo Pharmaceutical Co., Ltd.
2016-11-24
1673-21-ND
Kyungbo Pharmaceutical Co...
South Korea
174, Silok-ro, Asan-si, C...
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Myungin Pharmaceutical Co., Ltd.
2014-05-30
Number 3838-8-ND(2)
Nosch Labs Pvt. Ltd@[Manu...
India
D.No.5-5-35/33/3, Prashan...