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

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01 Cyclosporine (1)

02 Deferasirox (1)

03 Diclofenac diethylamine salt (1)

04 Fluvastatin Sodium (1)

05 Hydrochlorothiazide (1)

06 Imatinib mesylate (1)

07 Indacaterol Maleate (2)

08 Ketotifen fumarate (1)

09 Mycophenolate Sodium (1)

10 Nilotinib hydrochloride monohydrate (2)

11 Oxcarbazepine (1)

12 Rivastigmine (2)

13 Rivastigmine Tartrate (2)

14 Sacubitril and valsartan sodium salt hydrate (1)

15 Telbivudine (1)

16 Terbinafine (1)

17 Terbinafine hydrochloride (1)

18 everolimus (2)

19 letrozole (1)

20 pasireotide pamoate (1)

21 ribociclib succinate (1)

22 valsartan (3)

23 vildagliptin (1)

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01 Bukwang Pharmaceutical Co., Ltd. (1)

02 GlaxoSmithKline Consumer Healthcare Korea Co., Ltd. (2)

03 Novartis Korea Co., Ltd. (25)

04 Samil Pharmaceutical Co., Ltd. (1)

05 Samo Pharmaceutical Co., Ltd. (1)

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01 Novartis Grimsby Limited (1)

02 Novartis Grimsby Ltd. (2)

03 Novartis Grimsby Ltd.@Novartis Pharma Stein AG_x000D_ (1)

04 Novartis Pharma AG (2)

05 Novartis Pharma AG@[sieving process] Novartis Pharma Stein AG (1)

06 Novartis Pharma Schweizerhalle AG.@Novartis Pharma Stein AG@Pharmaceutical Works Polpharma SA (1)

07 Novartis Pharma Schweizerhalle AG.@[Partial process consignment manufacturing (manufacturer)](Blending process) Novartis Pharma AG@[Partial process consignment manufacturing (manufacturer)](Blending process) Lek Pharmaceuticals dd@[Partial process consign (1)

08 Novartis Pharma Schweizerhalle AG@Novartis Pharma AG@Novartis Pharma Stein AG@Sterling Pharma Ringaskiddy Limited@Novartis Pharmaceutical Manufacturing LLC (1)

09 Novartis Pharma Schweizerhalle AG@Novartis Pharma Stein AG (2)

10 Novartis Pharma Schweizerhalle AG@Suanfarma Italia SpA@Novartis Pharma Stein AG (1)

11 Novartis Pharma Stein AG (1)

12 Novartis Pharma Stein AG@Novartis Grimsby Ltd,@Novartis Pharma Schweizerhalle AG] (1)

13 Novartis Pharma Stein AG@Novartis Pharma AG@Novartis Pharma Schweizerhalle AG@Sterling Pharma Ringaskiddy Limited@Novartis Pharmaceutical Manufacturing LLC (1)

14 Novartis Ringaskiddy Limited (1)

15 Novartis Ringaskiddy Limited@[Joppum Manufacturer] Sandoz GmbH_x000D_ (1)

16 Novartis Ringaskiddy Limited@[micronized manufacturing plant]Novartis Pharma Stein AG (1)

17 Novartis Ringaskiddy Ltd. (1)

18 Novartis ringaskiddy ltd (1)

19 Sterling Pharma Ringaskiddy Limited (2)

20 Sterling Pharma Ringaskiddy Limited@[Sifting Process Manufacturer]Novartis Pharma Stein AG (1)

21 Sterling Pharma Ringaskiddy Limited@[Sifting Process]Novartis Pharma Stein AG (1)

22 Sterling Pharma Ringaskiddy Limited@[sieving process manufactory]Novartis Pharma Stein AG (1)

23 [Micronized Manufacturing Plant] Novartis Pharma Stein AG@Novartis Grimsby Ltd. (1)

24 [Partial process consignment manufacturing (manufacturing requester)] (synthesis and blending process) Novartis Pharma AG@[partial process consignment manufacturing (manufacturer)] (blending process) Lek Pharmaceuticals dd@[partial process consignment man (1)

25 [Partial process consignment manufacturing (manufacturing requester)] Novartis Pharma AG@[Partial process consignment manufacturing (manufacturer)] Novartis Ringaskiddy Ltd@[Partial process consignment manufacturing (manufacturer)] Novartis Pharma Stein A (1)

26 [Partial process contract manufacturing (manufacturer)] (synthesis) Novartis Grimsby Ltd.@[Partial process contract manufacturing (manufacturer)] (mixing and grinding) Novartis Pharma Stein AG (1)

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01 Ireland (5)

02 Switzerland (22)

03 United Kingdom (3)

URL Supplier Web Content
Novartis Korea Co., Ltd.
2005-08-31
20050831-18-C-99-04
Novartis Ringaskiddy Limi...
Switzerland
Ringaskiddy, Co. Cork, Ir...
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Novartis Korea Co., Ltd.
2006-03-27
Number 163-4-ND
Novartis Pharma Schweizer...
Switzerland
Rothausstrasse, 4133, Pra...
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GlaxoSmithKline Consumer Healthcare Korea Co., Ltd.
2011-03-31
20110331-80-D-95-07
[Partial process contract...
Switzerland
[Partial process contract...
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Novartis Korea Co., Ltd.
2012-10-16
Wed163-11-ND
Novartis Pharma Schweizer...
Switzerland
Rothausstrasse, 4133 Prat...
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Novartis Korea Co., Ltd.
2005-09-08
Number 163-2-ND
[Partial process consignm...
Switzerland
[Partial process consignm...
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Novartis Korea Co., Ltd.
2021-07-11
20210711-209-J-1061
Novartis Ringaskiddy Ltd.
Ireland
Ringaskiddy, Co. Cork, Ir...
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Novartis Korea Co., Ltd.
2020-12-24
20201224-209-J-805
Novartis Pharma Schweizer...
Switzerland
Rothausstrasse, 4133 Prat...
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Novartis Korea Co., Ltd.
2005-09-08
Number 163-3-ND
Sterling Pharma Ringaskid...
Switzerland
Ringaskiddy, Cork, P43 FR...
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Novartis Korea Co., Ltd.
2024-01-29
Wed196-27-ND
Novartis Pharma Schweizer...
Switzerland
Rothausstrasse, 4133, Pra...
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Novartis Korea Co., Ltd.
2010-05-27
Wed163-10-ND
Novartis Pharma Stein AG@...
Switzerland
Schaffhauserstrasse, 4332...
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