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

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01 Fresenius Kabi Austria GmbH (1)

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01 Fresenius Kavi Korea Co., Ltd. (1)

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01 Hydroxyethyl starch 130000 (1)

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01 Austria (1)

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Fresenius Kavi Korea Co., Ltd.
2022-06-22
20220622-210-J-1318
Fresenius Kabi Austria Gm...
Austria
Estermannstraße 17, 4020...
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Looking for 9005-27-0 / Hydroxyethyl Starch API manufacturers, exporters & distributors?

Hydroxyethyl Starch manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Hydroxyethyl Starch 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 Hydroxyethyl Starch manufacturer or Hydroxyethyl Starch supplier for your needs.

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

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

API | Excipient name

Hydroxyethyl Starch

Synonyms

9005-27-0, Starch, 2-hydroxyethyl ether, 2-hydroxyethyl starch, (2s,3r,4s,5s,6r)-6-(hydroxymethyl)oxane-2,3,4,5-tetrol;2-[[(2r,3r,4s,5r,6s)-3,4,5,6-tetrakis(2-hydroxyethoxy)oxan-2-yl]methoxy]ethanol, Hydroxyethyl starch 130/0.4, Starch, 2-hydroxyethyl ether, base-hydrolyzed

Cas Number

9005-27-0

About Hydroxyethyl Starch

Hydroxyethyl starch (HES/HAES) is a nonionic starch derivative. Hydroxyethyl starches (HES) are synthetic colloids commonly used for fluid resuscitation to replace intravascular volume. HES is a general term and can be sub-classified according to average molecular weight, molar substitution, concentration, C2/C6 ratio and Maximum Daily Dose.

Hydroxyethyl Starch Manufacturers

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

Hydroxyethyl Starch Suppliers

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

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

Hydroxyethyl Starch KDMF

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

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

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

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

Hydroxyethyl Starch Manufacturers | Traders | Suppliers

Hydroxyethyl Starch Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Hydroxyethyl Starch

Get in contact with the supplier of your choice:

  1. Fresenius Kabi Austria
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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