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List of Drug Master Files (KDMF) for DSSTox_CID_3581 Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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$ API Ref.Price (USD/KG) : 227Xls
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01 1AUROBINDO PHARMA LIMITED

02 1Artemis Biotech (A Division of Themis Medicare Ltd)

03 2Aurobindo Pharma Limited

04 10Biocon Limited

05 1Biocon Limited@Hwail Pharmaceutical Co., Ltd.

06 1Boryung Pharmaceutical Co., Ltd.

07 1Daewoong Bio Co., Ltd.

08 1Krebs Biochemicals & Industries Limited

09 1Kyungbo Pharmaceutical Co., Ltd.

10 2LUPIN Limited

11 1Lupine Limited

12 2M/s Hetero Labs Limited

13 1MSD International GmbH (Singapore Branch)

14 1MSD International GmbH@[Manufacturer of key intermediate (Simvastatin Ammonium Salt)①] Merck & Co., Inc. (Flint River Plant)@[Manufacturer of key intermediate (Simvastatin Ammonium Salt)②] Divi's Laboratories Limited (Unit-2)

15 1Merck Sharp & Dohme Ltd

16 1Sandoz Industrial Products SpA

17 4Shangyu Jingxin Pharmaceutical Co., Ltd. Ltd

18 2Shaoxing Jingxin Pharmaceutical Co., Ltd. Ltd@Livzon Group (Ningxia) Pharmaceutical Co., Ltd.

19 1Shaoxing Jingxin Pharmaceutical Co., Ltd.@Livzon Group (Ningxia) Pharmaceutical Co.,Ltd.

20 1TEVA Pharmaceutical Works Company Limited@Sterling Biotech Limited@Livzon Group (Ningxia) Pharmaceutical Co.,Ltd.

21 1Trustee: Samo Pharmaceutical

22 1Zhejiang Apeloa Pharmaceutical Co., Ltd

23 1Zhejiang Hisun Pharmaceutical Co., Ltd.

24 1Zhejiang Jiangbei Pharm Co., Ltd

25 2Zhejiang Jiangbei Pharm Co., Ltd.

26 1Zhejiang Jiangbei Pharmaceutical Co.,Ltd@Chongqing Daxin@Sterling Biotech Limited

27 1Zhejiang Jiangbei Pharmaceutical Co.,Ltd@Manufacturer of starting material 'Lovastatin' ① Chongqing Daxin@Manufacturer of starting material 'Lovastatin' ② Sterling Biotech Limited

28 1Zhejiang jiangbei Pharm Co.,Ltd.

29 1Zhejiang jiangbei Pharm Co.,Ltd.@[Starting material lovastatin manufacturer ①] Chongquing Daxin@[Starting material lovastatin manufacturer ② Sterling Biotech Limited]

30 1Zhejiang jiangbei Pharm Co.ltd

31 2Zhejiang jiangbei Pharm Co.ltd@Manufacturer of starting material 'Lovastatin' ① Chongqing Daxin@Manufacturer of starting material 'Lovastatin' ② Sterling Biotech Limited

32 1Zhejiang jiangbei Pharm Co.ltd@[Starting material lovastatin manufacturer ①] Chongquing Daxin@[Starting material lovastatin manufacturer ② Sterling Biotech Limited]

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PharmaCompass

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Simvastatin

Registrant Name : Abbott Korea Co., Ltd.

Registration Date : 2020-09-29

Registration Number : 20200929-29-B-437-28

Manufacturer Name : Krebs Biochemicals & Industr...

Manufacturer Address : Survey No. 157& 158, Kothapalli(V), Kasimkota(M) Visakhapatnam District Andhra Prades...

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Simvastatin

Registrant Name : Lihu Healthcare Co., Ltd.

Registration Date : 2018-04-11

Registration Number : 20180411-29-B-409-27

Manufacturer Name : Zhejiang Hisun Pharmaceutica...

Manufacturer Address : 56 Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province 318000

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Simvastatin

Registrant Name : Hanyoung Farm Co., Ltd.

Registration Date : 2021-04-06

Registration Number : 20120217-29-B-327-26(11)

Manufacturer Name : Zhejiang Jiangbei Pharmaceut...

Manufacturer Address : Dongdai Zhang'an Street Jiaojiang Taizhou City, China @Manufacturer of starting mater...

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Simvastatin

Registrant Name : Gapi Bio Co., Ltd.

Registration Date : 2020-05-19

Registration Number : 20120217-29-B-327-26(10)

Manufacturer Name : Zhejiang Jiangbei Pharmaceut...

Manufacturer Address : Dongdai Zhang'an Street Jiaojiang Taizhou City, China@No.21 . Founder Road, Shuitu To...

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Simvastatin

Registrant Name : Hiple Co., Ltd.

Registration Date : 2016-05-02

Registration Number : 20120217-29-B-327-26(8)

Manufacturer Name : Zhejiang Jiangbei Pharm Co.,...

Manufacturer Address : Dongdai village Zhang an Street, Jiaojiang, Taizhlu, Zhejiang

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Simvastatin

Registrant Name : Renew Medical Co., Ltd.

Registration Date : 2021-07-07

Registration Number : 20120217-29-B-327-26(12)

Manufacturer Name : Zhejiang jiangbei Pharm Co.l...

Manufacturer Address : Dongdai village Zhang an Street, Jiaojiang, Taizhou, Zhejiang @Manufacturer of starti...

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Simvastatin

Registrant Name : Hanjin Pharmaceutical

Registration Date : 2016-11-14

Registration Number : 20120217-29-B-327-26(9)

Manufacturer Name : Zhejiang Jiangbei Pharm Co.,...

Manufacturer Address : Dongdai village Zhang an Street, Jiaojiang, Taizhlu, Zhejiang, China

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Simvastatin

Registrant Name : Korea United Pharmaceutical Co., Ltd.

Registration Date : 2018-02-02

Registration Number : 20100930-29-B-306-24(5)

Manufacturer Name : Shangyu Jingxin Pharmaceutic...

Manufacturer Address : No 31, Weisan Road, Hangzhou Bay, Shangyu Economic and Technological Development Area

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Simvastatin

Registrant Name : Narsha Farm Co., Ltd.

Registration Date : 2016-11-22

Registration Number : 20100930-29-B-306-24(4)

Manufacturer Name : Shangyu Jingxin Pharmaceutic...

Manufacturer Address : No 31, Weisan Road, Zhejiang Hangzhou Bay Shangyu Industrial Area,Shangyu City, Zheji...

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Simvastatin

Registrant Name : Toru Co., Ltd.

Registration Date : 2021-10-26

Registration Number : 20100930-29-B-306-24(6)

Manufacturer Name : Shaoxing Jingxin Pharmaceuti...

Manufacturer Address : No.31, Weisan Road, Hangzhou Bay Shangyu Economic and Technological Development Area,...

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