01 1Corden Pharma Switzerland LLC
01 1Sanofi-Aventis Korea Co., Ltd.
01 1Eliglustat tartrate
01 1Germany
Registrant Name : Sanofi-Aventis Korea Co., Ltd.
Registration Date : 2019-09-26
Registration Number : Su63-7-ND
Manufacturer Name : Corden Pharma Switzerland LL...
Manufacturer Address : Eichenweg 1, 4410 Liestal, Switzerland
A Eliglustat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eliglustat, including repackagers and relabelers. The FDA regulates Eliglustat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eliglustat 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 Eliglustat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eliglustat supplier is an individual or a company that provides Eliglustat active pharmaceutical ingredient (API) or Eliglustat finished formulations upon request. The Eliglustat suppliers may include Eliglustat API manufacturers, exporters, distributors and traders.
click here to find a list of Eliglustat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price 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 Eliglustat Drug Master File in Korea (Eliglustat KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eliglustat. The MFDS reviews the Eliglustat KDMF as part of the drug registration process and uses the information provided in the Eliglustat KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eliglustat 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 Eliglustat API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Eliglustat suppliers with KDMF on PharmaCompass.
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