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

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

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

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01 Esomeprazolestrontium tetrahydrate (1)

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01 South Korea (1)

URL Supplier Web Content
Hanmi Fine Chemical Co., Ltd.
2010-12-30
20101230-127-H-115-02
Hanmi Fine Chemical Co., ...
South Korea
57 Gyeongje-ro, Siheung-s...
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Looking for 934714-36-0 / Esomeprazole Strontium API manufacturers, exporters & distributors?

Esomeprazole Strontium manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Esomeprazole Strontium

Synonyms

S-omeprazole strontium hydrate, Fm0f67, Esomeprazole strontium [usan], 934714-36-0, Fm-0f67, C5n25h3803

Cas Number

934714-36-0

Unique Ingredient Identifier (UNII)

C5N25H3803

About Esomeprazole Strontium

The S-isomer of omeprazole.

Esomeprazole Strontium Manufacturers

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

Esomeprazole Strontium Suppliers

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

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

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

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

Esomeprazole Strontium Manufacturers | Traders | Suppliers

Esomeprazole Strontium Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Esomeprazole Strontium

Get in contact with the supplier of your choice:

  1. Hanmi Pharmaceutical
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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