01 1AMPAC Fine Chemicals LLC_x000D_
02 1Cambrex Charles City, Inc_x000D_
03 1ST Pharm Co., Ltd.
01 3Gilead Sciences Korea Ltd.
01 3Sophosbuvir
01 1South Korea
02 2U.S.A
Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2015-09-07
Registration Number : Su6273-4-ND
Manufacturer Name : AMPAC Fine Chemicals LLC_x00...
Manufacturer Address : Highway 50 & Hazel Avenue, Rancho Cordova, CA 95670, USA
Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2015-08-26
Registration Number : Su6273-2-ND
Manufacturer Name : Cambrex Charles City, Inc_x0...
Manufacturer Address : 1205 11th Street, Charles City, lowa(IA) 50616, USA
Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2015-07-06
Registration Number : Su6273-1-ND
Manufacturer Name : ST Pharm Co., Ltd.
Manufacturer Address : 231 Hyeopnyeop-ro, Siheung-si, Gyeonggi-do
86
PharmaCompass offers a list of Sofosbuvir 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 Sofosbuvir manufacturer or Sofosbuvir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sofosbuvir manufacturer or Sofosbuvir supplier.
A EPCLUSA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of EPCLUSA, including repackagers and relabelers. The FDA regulates EPCLUSA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. EPCLUSA 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 EPCLUSA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A EPCLUSA supplier is an individual or a company that provides EPCLUSA active pharmaceutical ingredient (API) or EPCLUSA finished formulations upon request. The EPCLUSA suppliers may include EPCLUSA API manufacturers, exporters, distributors and traders.
click here to find a list of EPCLUSA 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 EPCLUSA Drug Master File in Korea (EPCLUSA KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of EPCLUSA. The MFDS reviews the EPCLUSA KDMF as part of the drug registration process and uses the information provided in the EPCLUSA KDMF to evaluate the safety and efficacy of the drug.
After submitting a EPCLUSA 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 EPCLUSA API can apply through the Korea Drug Master File (KDMF).
click here to find a list of EPCLUSA suppliers with KDMF on PharmaCompass.
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