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

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$ API Ref.Price (USD/KG) : 959Xls
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01 1Acebright (India) Pharma Private Limited

02 1Cdymax (India) Pharma Private Limited

03 3Cipla Limited

04 1Cipla Limited.

05 1Estifarm Co., Ltd._x000D_

06 1FIS FABBRICA ITALIANA SINTETICI SPA@FIS FABBRICA ITALIANA SINTETICI SPA

07 1Hetero Labs Limited(Unit-I)

08 1Intas Pharmaceuticals Limited

09 1Jari Pharmaceutical Co., Ltd.

10 1Jeil Pharmaceutical Co., Ltd.

11 1Kyungbo Pharmaceutical Co., Ltd.

12 1Lee Yeon Pharmaceutical Co., Ltd.

13 1Mac-Chem Products (India) Pvt.Ltd.

14 4Natco Pharma Limited

15 3Nosch Labs Pvt. Ltd

16 1PLIVA Croatia Ltd.

17 1Qilu Tianhe Pharmaceutical

18 1SUN PHARMACEUTICAL INDUSTRIES LTD.

19 1Shilpa Medicare Limited

20 1Shilpa Pharma Lifesciences Limited

21 1Shin Poong Pharmaceutical Co., Ltd.

22 1Suven Life Sciences Ltd

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PharmaCompass

01

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

Imatinib mesylate

Registrant Name : Alvogen Korea Co., Ltd.

Registration Date : 2019-06-27

Registration Number : Su522-2-ND

Manufacturer Name : Acebright (India) Pharma Pri...

Manufacturer Address : #116/117, KIADB Industrial Area, Jigani, Anekal, Taluk, Bangalore-560105, India

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02

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

Imatinib mesylate

Registrant Name : Toru Corporation

Registration Date : 2023-02-16

Registration Number : No. 522-2-ND(A)

Manufacturer Name : Cdymax (India) Pharma Privat...

Manufacturer Address : #116/117, KIADB Industrial Area, Jigani, Anekal, Taluk, Bangalore-560105, India

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03

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

Imatinib mesylate

Registrant Name : Novartis Korea Ltd.

Registration Date : 2022-10-18

Registration Number : 196-24-ND

Manufacturer Name : FIS FABBRICA ITALIANA SINTET...

Manufacturer Address : Via Massimo D'Antona, 13, 86039 Termoli Campobasso, Italy@Viale Milano, 26, 36075 Mon...

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04

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

Imatinib mesylate

Registrant Name : Samoh Pharmaceutical Co., Ltd.

Registration Date : 2022-04-08

Registration Number : 207-54-ND

Manufacturer Name : Intas Pharmaceuticals Limite...

Manufacturer Address : Plot No. 457 & 458, Village Matoda, Bavla road and Plot No. 191/218 P, Village Chacha...

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05

Discovery on Target
Not Confirmed
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Discovery on Target
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Imatinib mesylate

Registrant Name : Kyungbo Pharmaceutical Co., Ltd.

Registration Date : 2020-06-23

Registration Number : 1673-35-ND

Manufacturer Name : Jari Pharmaceutical Co., Ltd...

Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do @No. 18 Zhenhua Road, Lianyungang, China

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06

Discovery on Target
Not Confirmed
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Discovery on Target
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Imatinib mesylate

Registrant Name : Hyundai Bioland Co., Ltd.

Registration Date : 2022-08-04

Registration Number : 22-5-ND(B)

Manufacturer Name : Natco Pharma Limited

Manufacturer Address : Chemical Division, Mekaguda Village, Nandigama Mandal, Rangareddy District, Telagana ...

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07

Discovery on Target
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Discovery on Target
Not Confirmed

Imatinib mesylate

Registrant Name : Klasia Co., Ltd.

Registration Date : 2020-01-08

Registration Number : 22-5-ND(A)

Manufacturer Name : Natco Pharma Limited

Manufacturer Address : Chemical Division Mekaguda Village Nandigama Mandal Rangareddy District, Telangana, I...

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08

Discovery on Target
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Discovery on Target
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Imatinib mesylate

Registrant Name : Sungwoo Chemical Co., Ltd.

Registration Date : 2017-08-03

Registration Number : No. 3838-5-ND(2)

Manufacturer Name : Nosch Labs Pvt. Ltd

Manufacturer Address : Sy.No.14, Gaddapotharam (Village), IDA, Kazipally, Jinnaram (Mandal), Medak District,...

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09

Discovery on Target
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Discovery on Target
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Imatinib mesylate

Registrant Name : Sampoong Pharmachem Co., Ltd.

Registration Date : 2016-04-05

Registration Number : No. 5643-4-ND

Manufacturer Name : Qilu Tianhe Pharmaceutical

Manufacturer Address : No. 849 Dongjia Town, Licheng District, Jinan City, Shangdong Province, China

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10

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

Imatinib mesylate

Registrant Name : Sungwoo Chemical Co., Ltd.

Registration Date : 2019-09-02

Registration Number : 473-23-ND

Manufacturer Name : Hetero Labs Limited(Unit-I)

Manufacturer Address : Survey No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telan...

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