01 1Esteve Huayi Pharmaceutical Co., Ltd.
02 1Gilead Alberta ULC
01 2Gilead Sciences Korea Ltd.
01 2Bictegravir sodium
01 1China
02 1U.S.A
Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2019-01-17
Registration Number : Su205-16-ND
Manufacturer Name : Esteve Huayi Pharmaceutical ...
Manufacturer Address : Linhai Road, Yuecheng District, Shaoxing, 312071 Zhejiang China
Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2018-12-24
Registration Number : Su205-15-ND
Manufacturer Name : Gilead Alberta ULC
Manufacturer Address : 1021 Hayter Road, Edmonton, Alberta T6S 1A1, Canada
A Bictegravir Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bictegravir Sodium, including repackagers and relabelers. The FDA regulates Bictegravir Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bictegravir Sodium 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 Bictegravir Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bictegravir Sodium supplier is an individual or a company that provides Bictegravir Sodium active pharmaceutical ingredient (API) or Bictegravir Sodium finished formulations upon request. The Bictegravir Sodium suppliers may include Bictegravir Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Bictegravir Sodium 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 Bictegravir Sodium Drug Master File in Korea (Bictegravir Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bictegravir Sodium. The MFDS reviews the Bictegravir Sodium KDMF as part of the drug registration process and uses the information provided in the Bictegravir Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bictegravir Sodium 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 Bictegravir Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Bictegravir Sodium suppliers with KDMF on PharmaCompass.
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