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

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01 Aceclofenac (1)

02 Alogliptin Benzoate (1)

03 Altioctate Tromethamine salt (1)

04 Apixaban (1)

05 Atorvastatin Calcium (1)

06 Azathioprine (1)

07 Azelastine hydrochloride (1)

08 Azilsartan (1)

09 Biphenyldimethyldicarboxylate (1)

10 Choline Alposcerate (3)

11 Cilostazol (1)

12 Dapagliflozin citrate (1)

13 Dapagliflozin propanediol hydrate (1)

14 Dexlansoprazole hydrate (1)

15 Edoxabantosylate hydrate (1)

16 Empagliflozin (1)

17 Esomeprazole Magnesium Trihydrate (1)

18 Fenofibrate (1)

19 Fenofibrate Choline (1)

20 Fenofibric acid (1)

21 Indigo Carmine (1)

22 Ipragliflozin L-proline (1)

23 Loxoprofen sodium hydrate (1)

24 Mirabegron (1)

25 Mosapride citrate hydrate (1)

26 Nizatidine (1)

27 Pitavastatin Calcium Hydrate (1)

28 Rabeprazole sodium (1)

29 Ramosetron hydrochloride (1)

30 Rosuvastatin Calcium (1)

31 Sarpogrelate hydrochloride (1)

32 Sitagliptin hydrochloride hydrate (1)

33 Sitagliptin phosphate hydrate (1)

34 Tenofovir disoproxil fumarate (1)

35 Tofacitinib Citrate (1)

36 Tolterodine-L-tartrate (1)

37 Trimebutine (1)

38 Trimebutine maleate (2)

39 Tromethamine thiocnate salt (1)

40 Ursodeoxycholic acid (1)

41 Vonoprazan fumarate (1)

42 althioctic acid (1)

43 amlodipine besylate (1)

44 clopidogrel camsylate (1)

45 clopidogrel sulfate (1)

46 donepezil (1)

47 donepezil hydrochloride (1)

48 duloxetine hydrochloride (1)

49 ezetimibe (1)

50 facebooksostart (1)

51 laputidine (1)

52 peramivir hydrate (1)

53 polar prezinc (1)

54 valsartan (1)

55 vildagliptin (1)

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01 Korea Biochem Pharmaceutical Co., Ltd. (58)

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01 Korea Biochem Pharmaceutical Co., Ltd. (40)

02 Korea Biochem Pharmaceutical Co., Ltd. @Chongqing Southwest No.2 Pharmaceutical Factory Co., Ltd. (1)

03 Korea Biochem Pharmaceutical Co., Ltd. @Jiangsu Baoshenglongcheng Pharmaceutical Co. Ltd. (Zonizatidine Manufacturer)@M/s GMFC LABS PVT LTD (1)

04 Korea Biochem Pharmaceutical Co., Ltd. @Jiangsu Smk Pharmaceutical Co., Ltd. (starting material manufacturer) @Zhejiang Tianyu Pharmaceutical Co., Ltd. (1)

05 Korea Biochem Pharmaceutical Co., Ltd. @Maithili Life Sciences Private Limited (1)

06 Korea Biochem Pharmaceutical Co., Ltd. @Zhejiang East-Asia Pharmaceutical Co., Ltd. (1)

07 Korea Biochem Pharmaceutical Co., Ltd. @Zhejiang Tianyu Pharmaceutical Co., Ltd. (1)

08 Korea Biochem Pharmaceutical Co., Ltd. @Zhongshan Belling Biotechnology Co., Ltd (1)

09 Korea Biochem Pharmaceutical Co., Ltd. @[(4th Act) Pharmaceutical Manufacturer] Henan Dongtai Pharmaceutical Co.,Ltd._x000D_ @Magma Industries Ltd (1)

10 Korea Biochem Pharmaceutical Co., Ltd. @[Fukang Pharmaceutical Co., Ltd.] Shouguang Fukang Pharmaceutical Co., Ltd (1)

11 Korea Biochem Pharmaceutical Co., Ltd. @[Jopum Manufacturing Company] Hainan Shatingning Pharmaceutical Co., Ltd. (1)

12 Korea Biochem Pharmaceutical Co., Ltd. @[Manufacturer of starting material (atorvastatin tinterbutyl ester)] Zheijang LEPU pharmaceutical Co., Ltd. (1)

13 Korea Biochem Pharmaceutical Co., Ltd. @[thioctic acid manufacturing plant] KINSY, SL (1)

14 Korea Biochem Pharmaceutical Co., Ltd.@[Jopum Manufacturer①] Zhejiang Charioteer Pharmaceutical Co., Ltd.@[Jopum Manufacturer②] Lantech pharmaceuticals limited (1)

15 Korea Biochem Pharmaceutical Co., Ltd.@[Manufacturer of starting material (phthaloyl amlodipine)] Changzhou Ruming Pharmaceutical Company Ltd (1)

16 Korea Biochem Pharmaceutical Co., Ltd.@[Method 1][Crude Powder Manufacturer]Jiangsu ToHope Pharmaceutical Co., Ltd.@[Method 2][Crude Rthioctic Acid Manufacturer] Hainan Shatingning Pharmaceutical Co.,Ltd. (1)

17 Korea Biochem Pharmaceutical Co., Ltd.@[Second method crude product manufacturer①] Suzhou Fushilai Pharmaceutical Co., Ltd.@[Second method crude product manufacturer②] Shanghai Shyndec Pharmaceutical(Haimen) Co.,Ltd. (1)

18 Korea Biochem Pharmaceutical Co., Ltd.@[Suzhou Fushilai Pharmaceutical Co.,Ltd._x000D_ (1)

19 Korea United Biochem Pharmaceutical Co., Ltd. (1)

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01 South Korea (58)

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Korea Biochem Pharmaceutical Co., Ltd.
2011-12-15
20111216-31-C-290-16
Korea Biochem Pharmaceuti...
South Korea
204 Sandan-gil, Jeonui-my...
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Korea Biochem Pharmaceutical Co., Ltd.
2023-05-17
2152-20-ND
Korea Biochem Pharmaceuti...
South Korea
204, Sandan-gil, Jeonui-m...
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Korea Biochem Pharmaceutical Co., Ltd.
2017-12-15
20171215-166-I-541-13
Korea Biochem Pharmaceuti...
South Korea
204, Sandan-gil, Jeonui-m...
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Korea Biochem Pharmaceutical Co., Ltd.
2017-04-05
20170405-166-I-520-09
Korea Biochem Pharmaceuti...
South Korea
204 Sandan-gil, Jeonui-my...
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Korea Biochem Pharmaceutical Co., Ltd.
2014-07-21
20140721-130-H-264-44
Korea Biochem Pharmaceuti...
South Korea
204, Sandan-gil, Jeonui -...
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Korea Biochem Pharmaceutical Co., Ltd.
2022-09-21
2152-18-ND
Korea Biochem Pharmaceuti...
South Korea
204 Sandan-gil, Jeonui-my...
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Korea Biochem Pharmaceutical Co., Ltd.
2014-02-21
20140221-132-H-258-27
Korea Biochem Pharmaceuti...
South Korea
204@No.259 , Sandan-gil, ...
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Korea Biochem Pharmaceutical Co., Ltd.
2018-01-16
20180116-209-J-53
Korea Biochem Pharmaceuti...
South Korea
204 Sandan-gil, Jeonui-my...
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Korea Biochem Pharmaceutical Co., Ltd.
2014-06-30
20140630-44-C-331-10
Korea Biochem Pharmaceuti...
South Korea
204 Sandan-gil, Jeonui-my...
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Korea Biochem Pharmaceutical Co., Ltd.
2024-01-10
2152-22-ND
Korea Biochem Pharmaceuti...
South Korea
204, Sandan-gil, Jeonui-m...
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