01 1Janssen Pharmaceutical Sciences Unlimited Company.
01 1Korea Janssen Co., Ltd.
01 1Darunavir ethanolate
01 1U.S.A
Registrant Name : Korea Janssen Co., Ltd.
Registration Date : 2009-07-20
Registration Number : Su-217-10-ND
Manufacturer Name : Janssen Pharmaceutical Scien...
Manufacturer Address : Little Island Industrial EST., Little Island, Co. Cork, Ireland
A Prezista manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prezista, including repackagers and relabelers. The FDA regulates Prezista manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prezista 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 Prezista manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prezista supplier is an individual or a company that provides Prezista active pharmaceutical ingredient (API) or Prezista finished formulations upon request. The Prezista suppliers may include Prezista API manufacturers, exporters, distributors and traders.
click here to find a list of Prezista 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 Prezista Drug Master File in Korea (Prezista KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Prezista. The MFDS reviews the Prezista KDMF as part of the drug registration process and uses the information provided in the Prezista KDMF to evaluate the safety and efficacy of the drug.
After submitting a Prezista 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 Prezista API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Prezista suppliers with KDMF on PharmaCompass.
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