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

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01 Alembic Pharmaceuticals Limited (Unit-Ⅰ) (2)

02 PLIVA Croatia Ltd@ABBVIE INC@HEC Pharm Co., Ltd.@Anuh Pharma Ltd. (1)

03 Pfizer Asia Manufacturing Pte Ltd@[erythromycin manufacturing plant ①]Abb Vie Inc@[erythromycin manufacturing plant ②]HEC Pharm Co., Ltd@Pliva Croatia Ltd@Alembic Pharmaceuticals Limited (1)

04 Pfizer Ireland Pharmaceuticals (1)

05 Pfizer Pharmaceuticals LLC (1)

06 Zhejiang Guobang Pharmaceutical Co., Ltd. (6)

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01 Ace Biopharm Co., Ltd. (1)

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

03 Hwail Pharmaceutical Co., Ltd. (1)

04 Kolon Pharmaceutical Co., Ltd. (1)

05 Kyungdong Pharmaceutical Co., Ltd. (2)

06 Pfizer Pharmaceuticals Korea Co., Ltd. (3)

07 Samo Pharmaceutical Co., Ltd. (1)

08 Sangjin Trading Co., Ltd. (2)

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01 Azithromycin (10)

02 Azithromycin hydrate (2)

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01 China (6)

02 Croatia (1)

03 India (2)

04 U.S.A (3)

URL Supplier Web Content
Sangjin Trading Co., Ltd.
2013-05-03
20130503-191-I-145-06
Alembic Pharmaceuticals L...
India
Vill. Panelav, POTajpura,...
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Kyungdong Pharmaceutical Co., Ltd.
2022-06-23
20130503-191-I-145-06(1)
Alembic Pharmaceuticals L...
India
Vill. Panelav, POTajpura,...
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Pfizer Pharmaceuticals Korea Co., Ltd.
2020-10-14
20201014-191-I-595-07
Pfizer Asia Manufacturing...
U.S.A
31 Tuas South Avenue 6 Si...
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Samo Pharmaceutical Co., Ltd.
2023-06-02
20230602-191-I-654-08
PLIVA Croatia Ltd@ABBVIE ...
Croatia
Prudnicka cesta 54, Savsk...
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Ace Biopharm Co., Ltd.
2013-04-10
20130123-191-I-119-05(1)
Zhejiang Guobang Pharmace...
China
No.6, Weiwu Road, Hangzho...
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Aging Life Science Co., Ltd.
2019-05-22
20130123-191-I-119-05(5)
Zhejiang Guobang Pharmace...
China
No.6, Weiwu Road, Hangzho...
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Hwail Pharmaceutical Co., Ltd.
2015-08-13
20130123-191-I-119-05(2)
Zhejiang Guobang Pharmace...
China
No. 6, Weiwu Road, Hangzh...
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Kolon Pharmaceutical Co., Ltd.
2015-07-14
20130123-191-I-119-05(3)
Zhejiang Guobang Pharmace...
China
No. 6, Weiwu Road, Hangzh...
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Sangjin Trading Co., Ltd.
2013-01-23
20130123-191-I-119-05
Zhejiang Guobang Pharmace...
China
No. 6, Weiwu Road, Hangzh...
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