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

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01 Apixaban (1)

02 Aripiprazole (micronized) (1)

03 Azithromycin (1)

04 Azithromycin hydrate (1)

05 Bazedoxifene acetate (1)

06 Bupropion hydrochloride (2)

07 Clarithromycin (6)

08 Dabigatran etexilate mesylate (1)

09 Dapagliflozin (1)

10 Deferasirox (1)

11 Empagliflozin (2)

12 Etoricoxib (2)

13 Fenofibrate (5)

14 Fenofibrate Choline (7)

15 Fenofibric acid (3)

16 Fesoterodine fumarate (1)

17 Ivabradine hydrochloride (1)

18 Leflunomide (1)

19 Lercanidipine hydrochloride (1)

20 Losartan Potassium (1)

21 Memantine hydrochloride (2)

22 Micronized Masitentan (1)

23 Micronized fenofibrate (1)

24 Odesmethylvenlafaxine (3)

25 Olaparib (1)

26 Olmesartan medoxomil (1)

27 Osimertinib mesylate (1)

28 Prasugrel (1)

29 Prasugrel hydrochloride (1)

30 Pregabalin (1)

31 Rivaroxaban (10)

32 Rivaroxaban (micronized) (1)

33 Rivastigmine Tartrate (1)

34 Ropinirole hydrochloride (2)

35 Sacubitril and valsartan sodium salt hydrate (1)

36 Solifenacin succinate (3)

37 Telmisartan (4)

38 Ticagrelor (1)

39 Vortioxetine hydrobromide (1)

40 bosentan (1)

41 candesartan cilexetil (4)

42 duloxetine hydrochloride (1)

43 facebooksostart (1)

44 lacosamide (1)

45 losartan potassium (1)

46 roxithromycin (13)

47 tadalafil (5)

48 valsartan (4)

49 vardenafil hydrochloride hydrate (1)

50 vildagliptin (1)

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01 Ace Biopharm Co., Ltd. (2)

02 Aging Life Science Co., Ltd. (5)

03 Alvogen Korea Co., Ltd. (1)

04 Anguk Pharmaceutical Co., Ltd. (1)

05 Binex Co., Ltd. (1)

06 Daewon Pharmaceutical Co., Ltd. (1)

07 Dasan Pharmaceutical Co., Ltd. (1)

08 Dongkwang Pharmaceutical Co., Ltd. (2)

09 Dongwha Pharmaceutical Co., Ltd. (1)

10 Ellison Pharmaceutical Co., Ltd. (1)

11 Eltech Pharmachem Co., Ltd. (1)

12 Farm East Co., Ltd. (1)

13 Foosung Bio Co., Ltd. (2)

14 GMAX Pharmachem Co., Ltd. (1)

15 Hallym Pharmaceutical Co., Ltd. (1)

16 Hanmi Pharmaceutical Co., Ltd. (1)

17 Hanyoung Farm Co., Ltd. (1)

18 Hwail Pharmaceutical Co., Ltd. (5)

19 Hwanin Pharmaceutical Co., Ltd. (1)

20 IMCD Korea Co., Ltd. (2)

21 Ildong Pharmaceutical Co., Ltd. (1)

22 Ilhwa Co., Ltd. (1)

23 JW Pharmaceutical Co., Ltd. (1)

24 KR Farm Co., Ltd. (1)

25 Kookjeon Pharmaceutical Co., Ltd. (5)

26 Korea Pharmaceutical Co., Ltd. (1)

27 Korea United Pharmaceutical Co., Ltd. (1)

28 Kwangdong Pharmaceutical Co., Ltd. (1)

29 Kyungdong Pharmaceutical Co., Ltd. (4)

30 Leaders Bio Co., Ltd. (2)

31 Leesung International Co., Ltd. (12)

32 Lihu Healthcare Co., Ltd. (1)

33 Mpeak Korea Co., Ltd. (5)

34 Narsha Farm Co., Ltd. (1)

35 Pharmapia Co., Ltd. (5)

36 SK Chemicals Co., Ltd. (1)

37 Samchundang Pharmaceutical Co., Ltd. (1)

38 Sandoz Korea Co., Ltd. (1)

39 Sangjin Trading Co., Ltd. (4)

40 Shinpoong Pharmaceutical Co., Ltd. (1)

41 Sungwoo Chemical Co., Ltd. (23)

42 Taewang Products Co., Ltd. (1)

43 Toru Co., Ltd. (2)

44 Wonpoong Pharmaceutical Co., Ltd. (1)

45 Youngjin Pharmaceutical Co., Ltd. (1)

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01 ALEMBIC PHARMACEUTICALS LTD. (1)

02 Alembic Pharmaceuticals Limited (50)

03 Alembic Pharmaceuticals Limited (API Division Panelav) (4)

04 Alembic Pharmaceuticals Limited (API Division-II) (11)

05 Alembic Pharmaceuticals Limited (API Division-II)@[Manufactory of starting material 'venlafaxine hydrochloride'] Alembic Pharmaceuticals Limited (API Division Panelav) (1)

06 Alembic Pharmaceuticals Limited (API Unit-1) (15)

07 Alembic Pharmaceuticals Limited (API Unit-I) (8)

08 Alembic Pharmaceuticals Limited (API Unit-I). (2)

09 Alembic Pharmaceuticals Limited (API Unit-III) (5)

10 Alembic Pharmaceuticals Limited (API Unit-lll) (2)

11 Alembic Pharmaceuticals Limited (Unit-III) (1)

12 Alembic Pharmaceuticals Limited (Unit-lll) (1)

13 Alembic Pharmaceuticals Limited (Unit-Ⅰ) (4)

14 Alembic Pharmaceuticals Limited (unit-III) (1)

15 Alembic Pharmaceuticals Limited@[Manufacturer of starting material (Trityl Olmesartan Medoxomil)] Zhejiang Huahai Pharmaceutical Co., Ltd. (1)

16 Alembic Pharmaceuticals Limited@[Valsartan Manufacturing Company]Alembic Pharmaceuticals Limited (1)

17 [Starting material ‘venlafaxine hydrochloride’ manufacturing site] Alembic Pharmaceuticals Limited (API Division Panelav)@Alembic Pharmaceuticals Limited (API Division-II) (1)

18 [Starting material ‘venlafaxine hydrochloride’ manufacturing site] Alembic Pharmaceuticals Limited(API Division)@Alembic Pharmaceuticals Limited(API Unit-II) (1)

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01 India (110)

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Sungwoo Chemical Co., Ltd.
2017-07-11
Number 473-18-ND
Alembic Pharmaceuticals L...
India
Plot No.842-843, Village-...
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Kookjeon Pharmaceutical Co., Ltd.
2022-12-22
20221222-209-J-1427
Alembic Pharmaceuticals L...
India
API Division Karakhadi, P...
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Sangjin Trading Co., Ltd.
2013-05-03
20130503-191-I-145-06
Alembic Pharmaceuticals L...
India
Vill. Panelav, POTajpura,...
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Kyungdong Pharmaceutical Co., Ltd.
2022-06-23
20130503-191-I-145-06(1)
Alembic Pharmaceuticals L...
India
Vill. Panelav, POTajpura,...
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Leesung International Co., Ltd.
2018-05-29
Wed21-5-ND
Alembic Pharmaceuticals L...
India
API DIVISION, KARAKHADI.,...
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Kookjeon Pharmaceutical Co., Ltd.
2012-12-05
Number 342-9-ND
ALEMBIC PHARMACEUTICALS L...
India
Plot No. 842-843, Village...
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Leesung International Co., Ltd.
2020-04-02
20200402-209-J-326
Alembic Pharmaceuticals L...
India
Survey No. 144P1, 144P2, ...
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Hwail Pharmaceutical Co., Ltd.
2020-05-19
20200402-209-J-326(1)
Alembic Pharmaceuticals L...
India
Survey No. 144P1, 144P2, ...
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Mpeak Korea Co., Ltd.
2020-07-29
20200213-209-J-339(3)
Alembic Pharmaceuticals L...
India
Survey No. 144P1, 144P2, ...
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Ildong Pharmaceutical Co., Ltd.
2020-07-21
20200213-209-J-339(2)
Alembic Pharmaceuticals L...
India
Survey No. 144P1, 144P2, ...
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