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

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01 Esomeprazole Sodium (1)

02 Gefitinib (1)

03 Micronized budesonide (3)

04 Omeprazole (2)

05 Ticagrelor (1)

06 felodipine (3)

07 formoterol fumarate hydrate (1)

08 fulvestrant (1)

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01 AstraZeneca Korea Co., Ltd. (10)

02 Handok Co., Ltd. (1)

03 Yuhan Corporation (2)

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01 AstraZeneca AB (3)

02 AstraZeneca AB @Aspen Oss BV (2)

03 AstraZeneca AB @Minakem Dunkerque production@Minakem Dunkerque production (1)

04 AstraZeneca UK Ltd. (2)

05 Astrazeneca AB (3)

06 Raw materials: AstraZeneca Bulk Production, Minakem Dunkerque SAS,@Granule: AstraZeneca AB Gartunavagen (1)

07 [Granule] AstraZeneca AB Gartunavagen@[Raw material manufacturer①] AstraZeneca AB_x000D_ @[Raw material manufacturer②]Minakem Dunkerque Production_x000D_ (1)

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01 Sweden (6)

02 United Kingdom (7)

URL Supplier Web Content
AstraZeneca Korea Co., Ltd.
2010-12-30
20101230-127-H-12-05
AstraZeneca AB
Sweden
Forskargatan 18, Sodertal...
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AstraZeneca Korea Co., Ltd.
2005-08-31
20050831-69-B-178-01
Astrazeneca AB
Sweden
Forskargatan 18, Sodertal...
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Handok Co., Ltd.
2011-06-15
20050831-69-B-178-01(2)
Astrazeneca AB
Sweden
Forskargatan 18, Sodertal...
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Yuhan Corporation
2011-04-29
20050831-69-B-178-01(1)
Astrazeneca AB
Sweden
Forskargatan 18, Sodertal...
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AstraZeneca Korea Co., Ltd.
2012-09-06
20120906-187-I-61-02
AstraZeneca AB
Sweden
Forskargatan 18, Sodertal...
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AstraZeneca Korea Co., Ltd.
2007-08-31
Number 661-4-ND
AstraZeneca UK Ltd.
United Kingdom
Silk Road Business Park, ...
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AstraZeneca Korea Co., Ltd.
2003-05-27
661-1-ND
AstraZeneca UK Ltd.
United Kingdom
Silk Road Business Park, ...
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AstraZeneca Korea Co., Ltd.
2021-10-25
20211025-209-J-1130
AstraZeneca AB @Minakem D...
United Kingdom
Forskargatan 18, Sodertal...
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AstraZeneca Korea Co., Ltd.
2021-10-25
20211025-209-J-1129
AstraZeneca AB @Aspen Oss...
United Kingdom
Forskargatan 18, Sodertal...
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AstraZeneca Korea Co., Ltd.
2021-08-28
20210828-209-J-1099
AstraZeneca AB @Aspen Oss...
United Kingdom
Forskargatan 18, Sodertal...
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