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

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01 Abacavir sulfate (1)

02 Amoxicillin Sodium (1)

03 Cabotegravir sodium (micronized) (1)

04 Cefuroxime Axetil (1)

05 Clobetasol propionate (2)

06 Dolutegravir sodium (1)

07 Dutasteride (1)

08 Eumeclidinium bromide (1)

09 Lacidipine (1)

10 Lamivudine (1)

11 Ondansetron (1)

12 Ondansetron hydrochloride hydrate (1)

13 Pazopanib hydrochloride (1)

14 Potassium clavulanate (5)

15 Ranitidine hydrochloride (1)

16 Vilanterol triphenatate (1)

17 amoxicillin hydrate (2)

18 cabotegravir (1)

19 cimetidine (1)

20 fluticasone furoate (1)

21 nabumetone (1)

22 naratriptan hydrochloride (1)

23 retapamulin (1)

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01 GlaxoSmithKline Co., Ltd. (22)

02 Ilsung Pharmaceutical Co., Ltd. (3)

03 Novartis Korea Co., Ltd. (1)

04 Samil Pharmaceutical Co., Ltd. (3)

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01 Beecham Pharmaceuticals (Pte) Ltd (2)

02 Glaxo Operations UK Limited (1)

03 Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) (1)

04 Glaxo Operations UK Limited(trading as Glaxo Wellcome Operations)@[Method 2 Cefuroxime Axetil intermediate manufacturing plant ①]Aurobindo Pharma Limited@[Method 2 Cefuroxime Axetil intermediate manufacturing plant ②]Nectar Life Sciences Limited (1)

05 Glaxo Operations UK Ltd (Trading as Glaxo Wellcome Operations) (1)

06 Glaxo Smith Kline@[partial process manufacturer] Lonza AG (1)

07 Glaxo SmithKline Ltd (1)

08 Glaxo Wellcome Manufacturing Pte Ltd (6)

09 Glaxo Wellcome Manufacturing Pte Ltd@Catalent Micron Technologies Limited@Glaxo Operations UK Ltd (Trading as Glaxo Wellcome Operations) (1)

10 Glaxo Wellcome Manufacturing Pte Ltd@[Pulverization Process Manufacturing Company]Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) (1)

11 Glaxo Wellcome Manufacturing Pte Ltd@[micronization process manufacturing company] Glaxo Operations UK Ltd (2)

12 Glaxo Wellcome Manufacturing Pte. Ltd.@[micron manufacturer] Catalent Micron Technologies Limited (1)

13 Glaxo Wellcome Manufacturing Pte. Ltd@[Micronization Manufacturer]Catalent Micron Technologies Limited (1)

14 GlaxoSmithKline Pharmaceuticals Limited (1)

15 SmithKline Beecham PLC (2)

16 SmithKline Beecham Pharm (1)

17 SmithKline Beecham Pharmaceuticals (3)

18 SmithKline Beecham Pharmaceuticals@[Starting material (amoxicillin trihydrate) manufacturer] Beecham Pharmaceuticals (Pte) Ltd (1)

19 The Wellcome Foundation Ltd (1)

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01 India (1)

02 Ireland (1)

03 Singapore (8)

04 United Kingdom (19)

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GlaxoSmithKline Co., Ltd.
2009-11-12
89-7-ND
Glaxo Operations UK Limit...
United Kingdom
Cobden Street, Montrose, ...
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Ilsung Pharmaceutical Co., Ltd.
2011-10-28
20050831-30-A-64-05(1)
Beecham Pharmaceuticals (...
Singapore
38 Quality Road Jurong In...
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GlaxoSmithKline Co., Ltd.
2005-08-31
20050831-30-A-64-05
Beecham Pharmaceuticals (...
Singapore
38 Quality Road Jurong In...
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GlaxoSmithKline Co., Ltd.
2014-04-21
20140421-30-A-291-19
SmithKline Beecham Pharma...
United Kingdom
Clarendon Road, Worthing,...
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GlaxoSmithKline Co., Ltd.
2022-02-03
Wed231-21-ND
Glaxo Wellcome Manufactur...
Singapore
1 Pioneer Sector 1, 62841...
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GlaxoSmithKline Co., Ltd.
2022-02-03
Wed231-20-ND
Glaxo Wellcome Manufactur...
United Kingdom
1 Pioneer Sector 1, 62841...
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Samil Pharmaceutical Co., Ltd.
2005-08-31
20050831-22-A-31-04
Glaxo Operations UK Limit...
United Kingdom
North Lonsdale Road, Ulve...
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GlaxoSmithKline Co., Ltd.
2005-08-31
20050831-27-B-66-03
Glaxo SmithKline Ltd
Ireland
Currabinny, Carrigaline, ...
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GlaxoSmithKline Co., Ltd.
2012-03-23
20120323-93-E-99-05
Glaxo Operations UK Limit...
United Kingdom
Cobden Street, Montrose, ...
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GlaxoSmithKline Co., Ltd.
2008-05-30
20080530-93-E-30-04
GlaxoSmithKline Pharmaceu...
India
2nd Pokhran Road, Thane 4...
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