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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Topharman Shandong Co Ltd to the U.S. FDA. Original Data : FDA Website

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01 1-((2R,3R,4R,5R)-3-FLUORO-4-HYDROXY-5-(HYDROXYMETHYL)-3-METHYLTETRAHYDROFURAN-2-YL) PYRIMIDINE-2,4(1H,3H)-DIONE (SOFOSBUVIR INTERMEDIATE) (1)

02 ARIPIPRAZOLE (1)

03 BREXPIPRAZOLE (1)

04 DAPOXETINE HYDROCHLORIDE (1)

05 EFINACONAZOLE (1)

06 NERATINIB MALEATE (1)

07 RIVAROXABAN (1)

08 TADALAFIL (1)

09 TELMISARTAN (1)

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01 TOPHARMAN SHANDONG CO LTD (9)

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01 China (9)

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01 Active (9)

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01 Complete (1)

02 Blank (8)

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TOPHARMAN SHANDONG CO...
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29576
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2015-08-31
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TOPHARMAN SHANDONG CO...
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28563
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2014-09-16
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TOPHARMAN SHANDONG CO...
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36360
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2022-06-15
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TOPHARMAN SHANDONG CO...
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37627
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2022-10-26
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TOPHARMAN SHANDONG CO...
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32479
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2018-02-02
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TOPHARMAN SHANDONG CO...
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37407
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2022-08-29
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TOPHARMAN SHANDONG CO...
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35602
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2021-02-04
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TOPHARMAN SHANDONG CO...
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33012
Complete
2021-08-25
2021-06-28
2018-08-10
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TOPHARMAN SHANDONG CO...
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28309
N/A
2014-05-22
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