01 1AMPAC Fine Chemicals LLC_x000D_
02 1Cambrex Charles City, Inc_x000D_
03 1Estifarm Co., Ltd.
01 3Gilead Sciences Korea Ltd.
01 3Sofosbuvir
01 1South Korea
02 2U.S.A
Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2015-09-07
Registration Number : No. 6273-4-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 : No. 6273-2-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 : No. 6273-1-ND
Manufacturer Name : Estifarm Co., Ltd.
Manufacturer Address : 231, Hyeop-ro, Siheung-si, Gyeonggi-do
A Sofosbuvir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sofosbuvir, including repackagers and relabelers. The FDA regulates Sofosbuvir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sofosbuvir 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 Sofosbuvir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sofosbuvir supplier is an individual or a company that provides Sofosbuvir active pharmaceutical ingredient (API) or Sofosbuvir finished formulations upon request. The Sofosbuvir suppliers may include Sofosbuvir API manufacturers, exporters, distributors and traders.
click here to find a list of Sofosbuvir 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 Sofosbuvir Drug Master File in Korea (Sofosbuvir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sofosbuvir. The MFDS reviews the Sofosbuvir KDMF as part of the drug registration process and uses the information provided in the Sofosbuvir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sofosbuvir 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 Sofosbuvir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sofosbuvir suppliers with KDMF on PharmaCompass.
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