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

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01 Amikacin sulfate (7)

02 Piperacillin Sodium (3)

03 Piperacillin Sodium Tazobactam Sodium 8:1 (3)

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01 Base Farm Co., Ltd. (1)

02 Chong Kun Dang Co., Ltd. (2)

03 DR Bio Korea Co., Ltd. (1)

04 Hansol Pharma Co., Ltd. (1)

05 Korea Union Pharmaceutical Co., Ltd. (1)

06 Penmix Co., Ltd. (1)

07 Pharmapia Co., Ltd. (1)

08 Sampoong Pharmachem Co., Ltd. (2)

09 Samsung Pharmaceutical Co., Ltd. (1)

10 Seongui Bio Co., Ltd. (1)

11 Unimed Pharmaceutical Co., Ltd. (1)

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01 Shandong Anxin Pharmaceutical Co., Ltd (7)

02 Shandong Anxin Pharmaceutical Co., Ltd @[Manufacturer of starting material ‘piperacillin’] Shandong Anshun Pharmaceutical Co., Ltd (1)

03 Shandong Anxin Pharmaceutical Co., Ltd. (formerly Qilu Tianhe Pharmaceutical. Co. Ltd)@[Piperacillin Sodium Manufacturing Company]Shandong Anshun Pharmaceutical Co., Ltd@[Tazobactam Sodium Manufacturing Company]Shandong Anshun Pharmaceutical Co., Ltd (1)

04 Shandong Anxin Pharmaceutical Co., Ltd@[Manufacturer of starting material 'piperacillin'] Shandong Anshun Pharmaceutical Co., Ltd (2)

05 Shandong Anxin Pharmaceutical Co., Ltd@[Manufacturer of starting material 'piperacillin'] Shandong Anshun Pharmaceutical Co., Ltd@[Manufacturer of starting material 'tazobactam sodium'] Shandong Anshun Pharmaceutical Co., Ltd (1)

06 Shandong Anxin Pharmaceutical Co., Ltd@[Manufacturing site for starting material 'piperacillin'] Shandong Anshun Pharmaceutical Co., Ltd@[Manufacturing site for starting material 'Tazobactam sodium'] Shandong Anshun Pharmaceutical Co., Ltd (1)

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01 China (13)

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Sampoong Pharmachem Co., Ltd.
2021-06-25
20210625-210-J-1038
Shandong Anxin Pharmaceut...
China
No.849 Dongjia Town Liche...
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Base Farm Co., Ltd.
2021-08-20
20210625-210-J-1038(4)
Shandong Anxin Pharmaceut...
China
No.849 Dongjia Town Liche...
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Korea Union Pharmaceutical Co., Ltd.
2021-08-20
20210625-210-J-1038(5)
Shandong Anxin Pharmaceut...
China
No.849 Dongjia Town Liche...
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Pharmapia Co., Ltd.
2021-08-20
20210625-210-J-1038(2)
Shandong Anxin Pharmaceut...
China
No.849 Dongjia Town Liche...
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Hansol Pharma Co., Ltd.
2021-08-20
20210625-210-J-1038(3)
Shandong Anxin Pharmaceut...
China
No.849 Dongjia Town Liche...
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Seongui Bio Co., Ltd.
2021-08-20
20210625-210-J-1038(6)
Shandong Anxin Pharmaceut...
China
No.849 Dongjia Town Liche...
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Unimed Pharmaceutical Co., Ltd.
2021-08-19
20210625-210-J-1038(1)
Shandong Anxin Pharmaceut...
China
No.849 Dongjia Town Liche...
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Samsung Pharmaceutical Co., Ltd.
2018-12-06
20180702-95-E-133-06(1)
Shandong Anxin Pharmaceut...
China
No.849 Dongjia Town, Lich...
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DR Bio Korea Co., Ltd.
2022-02-22
20180702-95-E-133-06(2)
Shandong Anxin Pharmaceut...
China
No.849 Dongjia Town, Lich...
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Sampoong Pharmachem Co., Ltd.
2018-07-02
20180702-95-E-133-06
Shandong Anxin Pharmaceut...
China
No.849 Dongjia Town, Lich...
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