01 1PolyPeptide Laboratories (Sweden) AB
01 1Korea Ferring Pharmaceutical Co., Ltd.
01 1Degarelix
01 1Switzerland
Registrant Name : Korea Ferring Pharmaceutical Co., Ltd.
Registration Date : 2013-03-18
Registration Number : Su3127-1-ND
Manufacturer Name : PolyPeptide Laboratories (Sw...
Manufacturer Address : Hogerudsgatan 21 SE-216 13 Limhamn
A Degarelix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Degarelix, including repackagers and relabelers. The FDA regulates Degarelix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Degarelix 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 Degarelix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Degarelix supplier is an individual or a company that provides Degarelix active pharmaceutical ingredient (API) or Degarelix finished formulations upon request. The Degarelix suppliers may include Degarelix API manufacturers, exporters, distributors and traders.
click here to find a list of Degarelix 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 Degarelix Drug Master File in Korea (Degarelix KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Degarelix. The MFDS reviews the Degarelix KDMF as part of the drug registration process and uses the information provided in the Degarelix KDMF to evaluate the safety and efficacy of the drug.
After submitting a Degarelix 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 Degarelix API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Degarelix suppliers with KDMF on PharmaCompass.
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