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

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01 Adapalene (1)

02 Agatro hemihydrate (1)

03 Atoxepant monohydrate (1)

04 Azacitidine (1)

05 Carfilzomib (1)

06 Evocal set (1)

07 Fedratinib hydrochloride hydrate (micronized) (1)

08 Fosnetupitant chloride hydrochloride (1)

09 Imidapryl hydrochloride (1)

10 Nirmatrelvir (1)

11 Palonosetron hydrochloride (1)

12 Teneligliptin hydrobromide hydrate (1)

13 Valbenazine Itosylate (1)

14 avanafil (1)

15 badadustat (1)

16 diltiazem hydrochloride (1)

17 trifarotene (1)

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01 AbbVie Korea Co., Ltd. (1)

02 Amgen Korea Limited (1)

03 BMS Korea Pharmaceutical Co., Ltd. (2)

04 Donga ST Co., Ltd. (1)

05 Galderma Korea Co., Ltd. (1)

06 HK Innoen Co., Ltd. (3)

07 Handok Co., Ltd. (1)

08 JW Pharmaceutical Co., Ltd. (1)

09 Kyowa Kirin Korea Co., Ltd. (1)

10 Mitsubishi Nabe Pharma Korea Co., Ltd. (3)

11 Pfizer Pharmaceuticals Korea Co., Ltd. (1)

12 Sinex Co., Ltd. (1)

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01 Changzhou SynTheAll Pharmaceutical Co., Ltd (4)

02 HAS Healthcare Advanced Synthesis SA (6)

03 Mitsubishi Nabe Pharma Korea Co., Ltd. @Hovione FarmaCiencia SA (1)

04 Mitsubishi Tanabe Pharma Factory (1)

05 Mitsubishi Tanabe Pharma Factory Ltd. (1)

06 Mitsubishi Tanabe Pharma Factory Ltd., Onoda Plant (4)

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01 China (4)

02 Japan (7)

03 Switzerland (6)

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Galderma Korea Co., Ltd.
2023-08-24
20230824-209-J-1527
HAS Healthcare Advanced S...
Switzerland
Via Industria 24, 6710 Bi...
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Mitsubishi Nabe Pharma Korea Co., Ltd.
2022-01-21
20220121-210-J-1219
Mitsubishi Tanabe Pharma ...
Japan
7473-2, Ooaza Onoda, Sany...
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JW Pharmaceutical Co., Ltd.
2011-07-15
Wed269-7-ND
Mitsubishi Tanabe Pharma ...
Japan
7473-2, Oaza Onoda, Sanyo...
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BMS Korea Pharmaceutical Co., Ltd.
2022-03-04
Number 342-17-ND
HAS Healthcare Advanced S...
Switzerland
Via Industria 24, 6710 Bi...
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Mitsubishi Nabe Pharma Korea Co., Ltd.
2023-03-13
Number 40-2-ND
Changzhou SynTheAll Pharm...
China
No. 589 North Yulong Road...
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Amgen Korea Limited
2016-08-18
Number 36-2-ND
HAS Healthcare Advanced S...
Switzerland
Via Industria 24, 6710 Bi...
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HK Innoen Co., Ltd.
2022-10-20
20221020-209-J-1386
Mitsubishi Tanabe Pharma ...
Japan
7473-2, Ooaza Onoda, Sany...
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BMS Korea Pharmaceutical Co., Ltd.
2022-04-27
Number 342-18-ND
Changzhou SynTheAll Pharm...
China
No. 589 North Yulong Road...
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HK Innoen Co., Ltd.
2022-10-31
Wed203-8-ND
HAS Healthcare Advanced S...
Switzerland
Via Industria 24, 6710 Bi...
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Donga ST Co., Ltd.
2013-06-14
20130614-160-I-325-02
Mitsubishi Tanabe Pharma ...
Japan
7473-2, Ooaza Onoda, Sany...
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