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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dolutegravir, including repackagers and relabelers. The FDA regulates Dolutegravir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dolutegravir 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dolutegravir supplier is an individual or a company that provides Dolutegravir active pharmaceutical ingredient (API) or Dolutegravir finished formulations upon request. The Dolutegravir suppliers may include Dolutegravir API manufacturers, exporters, distributors and traders.
click here to find a list of Dolutegravir 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 Drug Master File in Korea (Dolutegravir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dolutegravir. The MFDS reviews the Dolutegravir KDMF as part of the drug registration process and uses the information provided in the Dolutegravir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dolutegravir 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dolutegravir suppliers with KDMF on PharmaCompass.
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