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

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01 Cefazedone Sodium (1)

02 Cefcaphen pivoxyl hydrochloride hydrate (1)

03 Cefepime hydrochloride hydrate (2)

04 Ceftriaxone sodium hydrate (1)

05 Cephamandolnaphate (1)

06 Dexlansoprazole (1)

07 Erdostein (1)

08 Flomoxev free acid (1)

09 Sarpogrelate hydrochloride (1)

10 Solifenacin succinate (1)

11 Sulbactam sodium, cefoperazone sodium (1)

12 Vonoprazan fumarate (1)

13 cefotetan (1)

14 cefotiam hydrochloride (3)

15 cycloserine (1)

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01 SPC Co., Ltd. (17)

02 Youngjin Pharmaceutical Co., Ltd. (1)

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01 SPC Co., Ltd. (14)

02 SPC Co., Ltd. @[Jopum Manufacturing Company] NCPC Hebei Huamin Pharmaceutical Co., Ltd. (1)

03 SPC Co., Ltd. @[Rough product manufacturer ①] Youngjin Pharmaceutical Co., Ltd. @[Random product manufacturer ②] NG Chem Life Science Co., Ltd. (1)

04 SPC Co., Ltd.@[Suzhou Dawnrays Pharmaceutical Co.,Ltd_x000D_ (1)

05 [Sulbactam Sodium Manufacturing Plant②] Shandong Luoxin Pharmaceutical Group Hengxin Pharmaceutical Co., Ltd.@SPC Co., Ltd.@[Sulbactam Sodium Manufacturing Plant②] Shinpoong Pharmaceutical Co., Ltd. (1)

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01 South Korea (18)

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SPC Co., Ltd.
2020-03-10
20200310-210-J-579
SPC Co., Ltd.
South Korea
386 Pyeongtaekhangman-gil...
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SPC Co., Ltd.
2016-04-06
5298-1-ND
SPC Co., Ltd.
South Korea
386 Pyeongtaekhangman-gil...
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SPC Co., Ltd.
2017-11-07
20171107-84-D-144-09
SPC Co., Ltd. @[Jopum Man...
South Korea
386 Pyeongtaekhangman-gil...
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SPC Co., Ltd.
2021-01-29
20210129-84-D-157-12
SPC Co., Ltd.
South Korea
386 Pyeongtaekhangman-gil...
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SPC Co., Ltd.
2022-11-17
20221117-210-J-1405
SPC Co., Ltd.
South Korea
386 Pyeongtaekhangman-gil...
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Youngjin Pharmaceutical Co., Ltd.
2016-12-14
20151126-117-G-132-08(1)
SPC Co., Ltd.
South Korea
386 Pyeongtaekhangman-gil...
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SPC Co., Ltd.
2014-09-12
20140912-117-G-124-07
SPC Co., Ltd. @[Rough pro...
South Korea
386 Pyeongtaekhangman-gil...
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SPC Co., Ltd.
2015-11-26
20151126-117-G-132-08
SPC Co., Ltd.
South Korea
386 Pyeongtaekhangman-gil...
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SPC Co., Ltd.
2015-05-01
20150501-116-G-126-12
SPC Co., Ltd.@[Suzhou Daw...
South Korea
386@No.22 , Pyeongtaekhan...
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SPC Co., Ltd.
2022-03-14
20220314-210-J-1248
SPC Co., Ltd.
South Korea
386 Pyeongtaekhangman-gil...
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