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

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01 Minakem Dunkerque Production (1)

02 Minakem Dunkerque production (5)

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

04 Metrochem API PVT LTD (9)

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

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

07 Chong Kun Dang Co., Ltd. (2)

08 Cipla Limited (2)

09 FIS Fabbrica Italiana Sintetici SpA (2)

10 Glenmark Life Sciences Limited (4)

11 Glenmark Life Sciences Limited. (2)

12 Glenmark Lifesciences Limited (1)

13 Glenmark Pharmaceuticals Limited (2)

14 Hanmi Fine Chemical Co., Ltd. (1)

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

16 Hetero Drugs Limited (2)

17 Hetero Drugs Limited (Unit-IX) (5)

18 Hetero Drugs Limited Unit I (1)

19 Hetero Drugs Limited. (1)

20 Hetero Labs Limited (1)

21 Jiangsu Zhongbang Pharmaceutical Co.,Ltd (1)

22 Jubilant Pharmova Limited (3)

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

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

25 Kyungdong Pharmaceutical Co., Ltd. (1)

26 Lee Pharma Limited (10)

27 Lee Pharma Limited. (3)

28 Lee Pharma Limited@Lee Pharma Limited (1)

29 Nosch Labs PVT LTD., Unit-IV (1)

30 Nosch Labs Pvt. Ltd (2)

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

32 Nosch Labs. PVT.LTD. (2)

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

34 Shinpoong Pharmaceutical Co., Ltd. (1)

35 Union Quimico Farmaceutica, S.A., (1)

36 Vasudha Pharma Chem Limited (1)

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01 Aging Life Science Co., Ltd. (3)

02 AstraZeneca Korea Co., Ltd. (1)

03 CTC Bio Co., Ltd. (1)

04 Chong Kun Dang Co., Ltd. (4)

05 Daehan New Farm Co., Ltd. (1)

06 Daesin Pharmaceutical Co., Ltd. (2)

07 Dasan Pharmaceutical Co., Ltd. (1)

08 Farm East Co., Ltd. (2)

09 FarmChem Service Co., Ltd. (1)

10 Grace Farm (1)

11 Hana Pharmaceutical Co., Ltd. (1)

12 Hanmi Fine Chemical Co., Ltd. (1)

13 Hanmi Pharmaceutical Co., Ltd. (1)

14 Hanseochem Co., Ltd. (1)

15 Hiple Co., Ltd. (2)

16 Hwail Pharmaceutical Co., Ltd. (1)

17 IMCD Korea Co., Ltd. (1)

18 JHAT Co., Ltd. (1)

19 Kookjeon Pharmaceutical Co., Ltd. (2)

20 Korea Biochem Pharmaceutical Co., Ltd. (1)

21 Korea United Pharmaceutical Co., Ltd. (2)

22 Kyungbo Pharmaceutical Co., Ltd. (1)

23 Kyungdong Pharmaceutical Co., Ltd. (1)

24 Leaders Bio Co., Ltd. (1)

25 Leesung International Co., Ltd. (3)

26 Medi Poem Co., Ltd. (1)

27 Mpeak Korea Co., Ltd. (4)

28 Narsha Farm Co., Ltd. (1)

29 Otran Farm Korea Co., Ltd. (1)

30 Pampia Co., Ltd. (1)

31 Pharma Solution Co., Ltd. (1)

32 Pharmapia Co., Ltd. (8)

33 SG Biochem Co., Ltd. (3)

34 SK Chemicals Co., Ltd. (1)

35 Samchundang Pharmaceutical Co., Ltd. (1)

36 Samjin Pharmaceutical Co., Ltd. (1)

37 Samo Pharmaceutical Co., Ltd. (3)

38 Sangjin Trading Co., Ltd. (1)

39 Seongui Bio Co., Ltd. (1)

40 Shinpoong Pharmaceutical Co., Ltd. (1)

41 Sungjin Exim Co., Ltd. (1)

42 Sungwoo Chemical Co., Ltd. (3)

43 Toru Co., Ltd. (3)

44 UN Generic Co., Ltd. (2)

45 UNUST Co., Ltd. (2)

46 Wooshin Rabotachi Co., Ltd. (2)

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01 Esomeprazole (4)

02 Esomeprazole Magnesium Dihydrate (30)

03 Esomeprazole Magnesium Granules (1)

04 Esomeprazole Magnesium Hydrate (6)

05 Esomeprazole Magnesium Salt (1)

06 Esomeprazole Magnesium Salt Trihydrate (1)

07 Esomeprazole Magnesium Trihydrate (32)

08 Esomeprazole Magnesium Trihydrate (micronized) (2)

09 Esomeprazole Magnesium Trihydrate Pellets (1)

10 Micronized S-omeprazole Magnesium Trihydrate (1)

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01 China (1)

02 France (9)

03 India (55)

04 Italy (2)

05 South Korea (10)

06 Spain (1)

07 Blank (1)

Daehan New Farm Co., Ltd.
2020-03-11
20180627-127-H-339-30(4)
Minakem Dunkerque product...
France
224 avenue de la Dordogne...
Korea United Pharmaceutical Co., Ltd.
2021-08-10
20200904-127-H-381-38(1)
Athena Drug Delivery Solu...
France
Plot No. A-1 to A-5, MIDC...
Samo Pharmaceutical Co., Ltd.
2020-03-04
20151230-127-H-290-20(4)
Metrochem API PVT LTD
India
Unit-I, Plot No. 62/C/6, ...
Samchundang Pharmaceutical Co., Ltd.
2015-05-20
20131031-127-H-243-13(1)
Ethypharm@[Manufacturer o...
France
Zone industrielle de Sain...
Pharma Solution Co., Ltd.
2019-04-04
20180627-127-H-339-30(1)
Minakem Dunkerque product...
France
224 avenue de la Dordogne...
Pharmapia Co., Ltd.
2020-02-06
20180627-127-H-339-30(3)
Minakem Dunkerque product...
France
224 avenue de la Dordogne...
AstraZeneca Korea Co., Ltd.
2010-10-29
20101029-127-H-21-05
Minakem Dunkerque Product...
France
224 avenue de la Dordogne...
Mpeak Korea Co., Ltd.
2019-12-24
20180627-127-H-339-30(2)
Minakem Dunkerque product...
France
224 avenue de la Dordogne...
Aging Life Science Co., Ltd.
2018-06-27
20180627-127-H-339-30
Minakem Dunkerque product...
France
224 avenue de la Dordogne...
Samo Pharmaceutical Co., Ltd.
2020-03-04
20140902-127-H-256-15(3)
Metrochem API PVT LTD
India
Unit-I, Plot No. 62/C/6, ...

Looking for 95382-33-5 / Esomeprazole Magnesium API manufacturers, exporters & distributors?

Esomeprazole Magnesium manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Esomeprazole Magnesium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Esomeprazole Magnesium manufacturer or Esomeprazole Magnesium supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Esomeprazole Magnesium manufacturer or Esomeprazole Magnesium supplier.

PharmaCompass also assists you with knowing the Esomeprazole Magnesium API Price utilized in the formulation of products. Esomeprazole Magnesium API Price is not always fixed or binding as the Esomeprazole Magnesium Price is obtained through a variety of data sources. The Esomeprazole Magnesium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Esomeprazole Magnesium

Synonyms

Omeprazole magnesium, 161973-10-0, Prilosec otc, H 168/68 magnesium, 95382-33-5, Omeprazole (as magnesium)

Cas Number

95382-33-5

Unique Ingredient Identifier (UNII)

426QFE7XLK

About Esomeprazole Magnesium

The S-isomer of omeprazole.

Esomeprazole Manufacturers

A Esomeprazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esomeprazole, including repackagers and relabelers. The FDA regulates Esomeprazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esomeprazole API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Esomeprazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Esomeprazole Suppliers

A Esomeprazole supplier is an individual or a company that provides Esomeprazole active pharmaceutical ingredient (API) or Esomeprazole finished formulations upon request. The Esomeprazole suppliers may include Esomeprazole API manufacturers, exporters, distributors and traders.

click here to find a list of Esomeprazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Esomeprazole KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Esomeprazole Drug Master File in Korea (Esomeprazole KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Esomeprazole. The MFDS reviews the Esomeprazole KDMF as part of the drug registration process and uses the information provided in the Esomeprazole KDMF to evaluate the safety and efficacy of the drug.

After submitting a Esomeprazole KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Esomeprazole API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Esomeprazole suppliers with KDMF on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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