01 1Fresenius Kabi Austria GmbH
01 1Fresenius Kabi Korea Co., Ltd.
01 1Hydroxyethyl starch (130/0.4)
01 1Austria
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
47
PharmaCompass offers a list of Hydroxyethyl Starch API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.
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, and COA related information on PhamaCompass.
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, and COA related information on PharmaCompass.
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.
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