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

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01 Brigatinib (1)

02 Sofosbuvir (1)

03 Tenofovir disoproxil fumarate (1)

04 ruxolitinib phosphate (1)

05 temozolomide (1)

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01 Gilead Sciences Korea Ltd. (2)

02 MSD Korea Co., Ltd. (1)

03 Novartis Korea Co., Ltd. (1)

04 Takeda Pharmaceutical Korea Co., Ltd. (1)

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01 AMPAC Fine Chemicals LLC (1)

02 AMPAC Fine Chemicals LLC_x000D_ (1)

03 Ampac Fine Chemicals (2)

04 [Partial process plant (crude ruxolitinib phosphate manufacturing)] Ampac Fine Chemicals LLC@[Partial process plant (crude ruxolitinib phosphate recrystallization)] Sterling Pharma Ringaskiddy Limited@[Partial process plant (sieving process)] Novartis Pha (1)

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01 U.S.A (5)

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Takeda Pharmaceutical Korea Co., Ltd.
2020-04-21
Wed108-10-ND
Ampac Fine Chemicals
U.S.A
Highway 50 & Hazel Avenue...
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Novartis Korea Co., Ltd.
2016-11-24
Wed196-15-ND
[Partial process plant (c...
U.S.A
Highway 50 and Hazel Aven...
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Gilead Sciences Korea Ltd.
2015-09-07
Number 6273-4-ND
AMPAC Fine Chemicals LLC_...
U.S.A
Highway 50 & Hazel Avenue...
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MSD Korea Co., Ltd.
2005-03-16
406-1-ND
Ampac Fine Chemicals
U.S.A
Highway 50 & Hazel Avenue...
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Gilead Sciences Korea Ltd.
2011-04-29
22-6-ND
AMPAC Fine Chemicals LLC
U.S.A
US Hwy 50 and Hazel Ave. ...
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