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

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$ API Ref.Price (USD/KG) : 203Xls
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01 1Minakem Dunkerque Production

02 5Minakem Dunkerque production

03 1Athena Drug Delivery Solutions Pvt Ltd@[Esomeprazole Magnesium Dihydrate Manufacturer] Glenmark Life Sciences Limited

04 9Metrochem API PVT LTD

05 2Ethypharm@[Manufacturer of starting material 'S-omeprazole magnesium dihydrate'①] Cipla Limited@[Manufacturer of starting material 'S-omeprazole magnesium dihydrate'②] Cipla Limited

06 1Athena Drug Delivery Solutions Pvt Ltd@[Esomeprazole Magnesium Dihydrate Manufacturer]Glenmark Life Sciences Limited

07 2Chong Kun Dang Co., Ltd.

08 2Cipla Limited

09 2FIS Fabbrica Italiana Sintetici SpA

10 4Glenmark Life Sciences Limited

11 2Glenmark Life Sciences Limited.

12 1Glenmark Lifesciences Limited

13 2Glenmark Pharmaceuticals Limited

14 1Hanmi Fine Chemical Co., Ltd.

15 1Hanseochem Co., Ltd.@[Chooseomeprazole Sodium Manufacturer] Shouguang Fukang Pharmaceutical Co.,Ltd.

16 2Hetero Drugs Limited

17 5Hetero Drugs Limited (Unit-IX)

18 1Hetero Drugs Limited Unit I

19 1Hetero Drugs Limited.

20 1Hetero Labs Limited

21 1Jiangsu Zhongbang Pharmaceutical Co.,Ltd

22 3Jubilant Pharmova Limited

23 1Korea Biochem Pharmaceutical Co., Ltd. @[Fukang Pharmaceutical Co., Ltd.] Shouguang Fukang Pharmaceutical Co., Ltd

24 1Kyungbo Pharmaceutical Co., Ltd.@Jiangsu Zhongbang Pharmaceutical Co., Ltd.

25 1Kyungdong Pharmaceutical Co., Ltd.

26 10Lee Pharma Limited

27 3Lee Pharma Limited.

28 1Lee Pharma Limited@Lee Pharma Limited

29 1Nosch Labs PVT LTD., Unit-IV

30 2Nosch Labs Pvt. Ltd

31 3Nosch Labs Pvt. Ltd(Unit-II)

32 2Nosch Labs. PVT.LTD.

33 1Samjin Pharmaceutical Co., Ltd. @[Manufacturer of starting material ‘Esomeprazole Potassium’] Guilin Hwasun Pharmaceutical Co., Ltd.

34 1Shinpoong Pharmaceutical Co., Ltd.

35 1Union Quimico Farmaceutica, S.A.,

36 1Vasudha Pharma Chem Limited

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

Esomeprazole Magnesium Trihydrate

Registrant Name : Daehan New Farm Co., Ltd.

Registration Date : 2020-03-11

Registration Number : 20180627-127-H-339-30(4)

Manufacturer Name : Minakem Dunkerque production

Manufacturer Address : 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht Dunkerque, 59640 France

Minakem Comapny Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAthena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

Esomeprazole Magnesium Dihydrate

Registrant Name : Korea United Pharmaceutical Co., Ltd.

Registration Date : 2021-08-10

Registration Number : 20200904-127-H-381-38(1)

Manufacturer Name : Athena Drug Delivery Solutio...

Manufacturer Address : Plot No. A-1 to A-5, MIDC, Chemical zone, Ambernath(W), Thane 421 501 Maharashtra Sta...

Athena Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

Esomeprazole Magnesium Salt Trihydrate

Registrant Name : Samo Pharmaceutical Co., Ltd.

Registration Date : 2020-03-04

Registration Number : 20151230-127-H-290-20(4)

Manufacturer Name : Metrochem API PVT LTD

Manufacturer Address : Unit-I, Plot No. 62/C/6, Pipeline Road, Phase-I, IDA, Jeedimetla, Quthbullapur(M), Me...

Metrochem

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Esomeprazole Magnesium Dihydrate

Registrant Name : Samchundang Pharmaceutical Co., Ltd.

Registration Date : 2015-05-20

Registration Number : 20131031-127-H-243-13(1)

Manufacturer Name : Ethypharm@[Manufacturer of s...

Manufacturer Address : Zone industrielle de Saint-Arunoult 28 170 Chateauneuf-en-Thymerais, France@Old Madra...

Ethypharm

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

Esomeprazole Magnesium Trihydrate

Registrant Name : Mpeak Korea Co., Ltd.

Registration Date : 2019-12-24

Registration Number : 20180627-127-H-339-30(2)

Manufacturer Name : Minakem Dunkerque production

Manufacturer Address : 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht Dunkerque, 59640 France

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06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

Esomeprazole Magnesium Trihydrate

Registrant Name : Aging Life Science Co., Ltd.

Registration Date : 2018-06-27

Registration Number : 20180627-127-H-339-30

Manufacturer Name : Minakem Dunkerque production

Manufacturer Address : 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht Dunkerque, 59640 France

Minakem Comapny Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

Esomeprazole Magnesium Trihydrate

Registrant Name : Pharma Solution Co., Ltd.

Registration Date : 2019-04-04

Registration Number : 20180627-127-H-339-30(1)

Manufacturer Name : Minakem Dunkerque production

Manufacturer Address : 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht Dunkerque, 59640 France

Minakem Comapny Banner

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

Esomeprazole Magnesium Trihydrate

Registrant Name : AstraZeneca Korea Co., Ltd.

Registration Date : 2010-10-29

Registration Number : 20101029-127-H-21-05

Manufacturer Name : Minakem Dunkerque Production

Manufacturer Address : 224 avenue de la Dordogne Zone d'Entreprises du Nord Gracht 59640 Dunkerque, France

Minakem Comapny Banner

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

Esomeprazole Magnesium Trihydrate

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2020-02-06

Registration Number : 20180627-127-H-339-30(3)

Manufacturer Name : Minakem Dunkerque production

Manufacturer Address : 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht Dunkerque, 59640 France

Minakem Comapny Banner

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

Esomeprazole Magnesium Dihydrate

Registrant Name : Samo Pharmaceutical Co., Ltd.

Registration Date : 2020-03-04

Registration Number : 20140902-127-H-256-15(3)

Manufacturer Name : Metrochem API PVT LTD

Manufacturer Address : Unit-I, Plot No. 62/C/6, Pipeline Road, Phase-I, IDA, Jeedimetla, Quthbullapur(M), Me...

Metrochem