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01 1Fresenius Kabi Austria GmbH

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Medizin 2025
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Medizin 2025
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Hydroxyethyl starch (130/0.4)

Registrant Name : Fresenius Kabi Korea Co., Ltd.

Registration Date : 2022-06-22

Registration Number : 20220622-210-J-1318

Manufacturer Name : Fresenius Kabi Austria GmbH

Manufacturer Address : Estermannstraße 17, 4020 Linz, Austria

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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
69

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.