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Coral Budesonide Coral Budesonide

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

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01 Minakem Dunkerque production (2)

02 Minakem Dunkerque production@AstraZeneca AB (2)

03 Farmabios SpA@Microchem Srl (1)

04 Aspen Oss B.V. (1)

05 Aspen Oss BV@AstraZeneca AB (1)

06 Hubei Gedian Humanwell Pharmaceutical Co., Ltd. (1)

07 AVIK Pharmaceutical. Ltd (1)

08 AstraZeneca AB @Aspen Oss BV (2)

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

10 Newchem SpA@MICROCHEM Srl (1)

11 Sicor Societa' Italiana Corticosteroidi SRL@Micro-Macinazione SA (1)

12 Sterling SpA@Microchem Srl (1)

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01 AstraZeneca Korea Co., Ltd. (7)

02 Daewoong Pharmaceutical Co., Ltd. (1)

03 Hiple Co., Ltd. (1)

04 Samo Pharmaceutical Co., Ltd. (3)

05 Sinex Co., Ltd. (1)

06 Sungjin Exim Co., Ltd. (1)

07 Yuyu Pharmaceutical Co., Ltd. (1)

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01 Micronized budesonide (12)

02 budesonide (3)

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01 China (1)

02 France (4)

03 Germany (1)

04 India (1)

05 Italy (3)

06 Netherlands (2)

07 United Kingdom (3)

Daewoong Pharmaceutical Co., Ltd.
2023-07-19
20221124-209-J-1409(A)
Minakem Dunkerque product...
France
224 avenue de la Dordogne...
Samo Pharmaceutical Co., Ltd.
2020-06-01
20200601-209-J-448
Farmabios SpA@Microchem S...
Germany
27027, via Pavia 1, GROPE...
NA Not Available For Sales
AstraZeneca Korea Co., Ltd.
2022-11-24
20221124-209-J-1410
Aspen Oss BV@AstraZeneca ...
Netherlands
Veersemeer 4, Oss, 5347 J...
Samo Pharmaceutical Co., Ltd.
2021-03-29
20210329-209-J-903
Hubei Gedian Humanwell Ph...
China
Gedian Economic Developme...
AstraZeneca Korea Co., Ltd.
2021-07-21
20210721-209-J-1057
Minakem Dunkerque product...
France
224 avenue de la Dordogne...
AstraZeneca Korea Co., Ltd.
2022-11-24
20221124-209-J-1412
Minakem Dunkerque product...
France
224 avenue de la Dordogne...
AstraZeneca Korea Co., Ltd.
2022-11-24
20221124-209-J-1409
Minakem Dunkerque product...
France
224 avenue de la Dordogne...
NA Not Available For Sales
Sinex Co., Ltd.
2021-07-22
20210722-209-J-1071
Aspen Oss B.V.
Netherlands
Veersemeer 4, Oss, 5347 J...
URL Supplier Web Content
Samo Pharmaceutical Co., Ltd.
2022-06-07
20220607-209-J-1264
Sicor Societa' Italiana C...
Italy
Tenuta S. Alessandro 1304...
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