01 1Cambrex Charles City, Inc
02 1Esteve Huayi Pharmaceutical Co., Ltd.
03 1Fabbrica Italiana Sintetici SpA
04 2Gilead Alberta ULC
05 1Zenji Pharmaceuticals (Suzhou) Ltd.
01 5Gilead Sciences Korea Ltd.
02 1Sampoong Pharmachem Co., Ltd.
01 6Remdesivir
01 2China
02 1Italy
03 3U.S.A
Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2020-07-24
Registration Number : Su205-19-ND
Manufacturer Name : Cambrex Charles City, Inc
Manufacturer Address : 1205 11th Street - Charles City, IA 50616, USA
Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2020-07-24
Registration Number : Su205-20-ND
Manufacturer Name : Esteve Huayi Pharmaceutical ...
Manufacturer Address : Linhai Road Shaoxing Paojiang Industrial Zone Yuecheng District Shaoxing Zhejiang 312...
Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2020-07-24
Registration Number : Su205-17-ND
Manufacturer Name : Fabbrica Italiana Sintetici ...
Manufacturer Address : Viale Milano, 26 Montecchio Maggiore 36075 Italy
Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2024-11-25
Registration Number : Su205-28-ND
Manufacturer Name : Gilead Alberta ULC
Manufacturer Address : 1021 Hayter Road, Edmonton, Alberta, T6S 1A1, Canada
Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2020-07-24
Registration Number : Su205-18-ND
Manufacturer Name : Gilead Alberta ULC
Manufacturer Address : 1021 Hayter Road, Edmonton, Alberta, T6S 1A1, Canada
Registrant Name : Sampoong Pharmachem Co., Ltd.
Registration Date : 2022-03-30
Registration Number : No. 582-8-ND
Manufacturer Name : Zenji Pharmaceuticals (Suzho...
Manufacturer Address : No. 122, Xuqing Road, Xuguan, Suzhou City, Jiangsu Province, PR China
A Remdesivir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Remdesivir, including repackagers and relabelers. The FDA regulates Remdesivir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Remdesivir 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 Remdesivir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Remdesivir supplier is an individual or a company that provides Remdesivir active pharmaceutical ingredient (API) or Remdesivir finished formulations upon request. The Remdesivir suppliers may include Remdesivir API manufacturers, exporters, distributors and traders.
click here to find a list of Remdesivir 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 Remdesivir Drug Master File in Korea (Remdesivir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Remdesivir. The MFDS reviews the Remdesivir KDMF as part of the drug registration process and uses the information provided in the Remdesivir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Remdesivir 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 Remdesivir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Remdesivir suppliers with KDMF on PharmaCompass.
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