01 1FIS - Fabbrica Italiana Sintetici SpA
02 1finite chemical
01 2Gilead Sciences Korea Ltd.
01 2Elvitegravir
01 1Italy
02 1South Korea
Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2016-06-29
Registration Number : No. 6273-7-ND
Manufacturer Name : FIS - Fabbrica Italiana Sint...
Manufacturer Address : Viale Milano 26, 36075 Montecchio Maggiore, Vicenza, Italy
Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2016-06-29
Registration Number : No. 6273-6-ND
Manufacturer Name : finite chemical
Manufacturer Address : 45 Jiwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do
A Elvitegravir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elvitegravir, including repackagers and relabelers. The FDA regulates Elvitegravir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elvitegravir 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 Elvitegravir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Elvitegravir supplier is an individual or a company that provides Elvitegravir active pharmaceutical ingredient (API) or Elvitegravir finished formulations upon request. The Elvitegravir suppliers may include Elvitegravir API manufacturers, exporters, distributors and traders.
click here to find a list of Elvitegravir 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 Elvitegravir Drug Master File in Korea (Elvitegravir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Elvitegravir. The MFDS reviews the Elvitegravir KDMF as part of the drug registration process and uses the information provided in the Elvitegravir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Elvitegravir 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 Elvitegravir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Elvitegravir suppliers with KDMF on PharmaCompass.
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