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List of Korea Drug Master Files (KDMF) for Esomeprazole Sodium Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Flag France
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AstraZeneca Korea Co., Ltd.
2011-11-04
20111104-127-H-192-07
Minakem Dunkerque Product...
France
224 avenue de la Dordogne...
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Pharmapia Co., Ltd.
2019-11-05
20171031-127-H-320-29(2)
Metrochem API Private Lim...
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Hiple Co., Ltd.
2017-10-31
20171031-127-H-320-29
Metrochem API Private Lim...
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Samo Pharmaceutical Co., Ltd.
2016-05-20
20160520-127-H-304-23
Sun Pharmaceutical Indust...
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AstraZeneca Korea Co., Ltd.
2010-12-30
20101230-127-H-12-05
AstraZeneca AB
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Forskargatan 18, Sodertal...
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Korea Pharmbio Co., Ltd.
2018-07-30
20180730-127-H-338-32
Glenmark Pharmaceuticals ...
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Seongui Bio Co., Ltd.
2013-07-26
20130422-127-H-230-10(1)
Union Quimico Farmaceutic...
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Poligon Industrial Moli d...
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Sungjin Exim Co., Ltd.
2013-04-22
20130422-127-H-230-10
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  • INJECTABLE;INTRAVENOUS - EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE;INTRAVENOUS - EQ 40MG BASE/VIAL

Looking for 161796-78-7 / Esomeprazole Sodium API manufacturers, exporters & distributors?

Esomeprazole Sodium manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Esomeprazole Sodium 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 Sodium manufacturer or Esomeprazole Sodium supplier for your needs.

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

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

API | Excipient name

Esomeprazole Sodium

Synonyms

Esomeprazole (sodium), H199/18 sodium, Esomeprazole (as sodium), Esomeprazole sodium [usan], 161796-78-7, Esomeprazole sodium (usan)

Cas Number

161796-78-7

Unique Ingredient Identifier (UNII)

L2C9GWQ43H

About Esomeprazole Sodium

The S-isomer of omeprazole.

Esomeprazole Sodium Manufacturers

A Esomeprazole Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esomeprazole Sodium, including repackagers and relabelers. The FDA regulates Esomeprazole Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esomeprazole Sodium 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 Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Esomeprazole Sodium Suppliers

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

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

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

After submitting a Esomeprazole Sodium 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 Sodium API can apply through the Korea Drug Master File (KDMF).

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

Esomeprazole Sodium Manufacturers | Traders | Suppliers

Esomeprazole Sodium Manufacturers, Traders, Suppliers 1
59

We have 6 companies offering Esomeprazole Sodium

Get in contact with the supplier of your choice:

  1. Minakem
  2. Metrochem API Private Limited
  3. Sun Pharmaceutical Industries Limited
  4. AstraZeneca
  5. Glenmark Life Sciences
  6. UQUIFA
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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