01 1Glaxo Wellcome Manufacturing Pte. Ltd@[Micronized Manufacturing Plant]Catalent Micron Technologies Limited
02 1Shionogi Pharma Co., Ltd.@[Some process manufacturers] Fujimoto Chemicals Co., Ltd. Senboku Plant
01 2GlaxoSmithKline Inc.
01 1Dolutegravir sodium
02 1Dolutegravir sodium (micronized)
01 1Japan
02 1United Kingdom
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2020-08-13
Registration Number : Su231-19-ND
Manufacturer Name : Glaxo Wellcome Manufacturing...
Manufacturer Address : 1 Pioneer Sector 1, Singapore 628413@[Micronising Manufactory]Crossways Boulevard, Cr...
Dolutegravir sodium (micronized)
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2014-08-01
Registration Number : Su2480-14-ND
Manufacturer Name : Shionogi Pharma Co., Ltd.@[S...
Manufacturer Address : 224-20, Hiraishiebisuno, Kawauchi-cho, Tokushima, Tokushima 771-0132, Japan@1-24, Rin...
A Dolutegravir / rilpivirine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dolutegravir / rilpivirine, including repackagers and relabelers. The FDA regulates Dolutegravir / rilpivirine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dolutegravir / rilpivirine 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 Dolutegravir / rilpivirine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dolutegravir / rilpivirine supplier is an individual or a company that provides Dolutegravir / rilpivirine active pharmaceutical ingredient (API) or Dolutegravir / rilpivirine finished formulations upon request. The Dolutegravir / rilpivirine suppliers may include Dolutegravir / rilpivirine API manufacturers, exporters, distributors and traders.
click here to find a list of Dolutegravir / rilpivirine 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 Dolutegravir / rilpivirine Drug Master File in Korea (Dolutegravir / rilpivirine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dolutegravir / rilpivirine. The MFDS reviews the Dolutegravir / rilpivirine KDMF as part of the drug registration process and uses the information provided in the Dolutegravir / rilpivirine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dolutegravir / rilpivirine 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 Dolutegravir / rilpivirine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dolutegravir / rilpivirine suppliers with KDMF on PharmaCompass.
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