01 1Janssen Pharmaceutica NV
01 1Korea Janssen Co., Ltd.
01 1Etravirine
01 1U.S.A
Registrant Name : Korea Janssen Co., Ltd.
Registration Date : 2008-05-07
Registration Number : Su217-3-ND
Manufacturer Name : Janssen Pharmaceutica NV
Manufacturer Address : Janssen Pharmaceuticalaan 3B-2440 Geel, Belgium
A Etravirine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Etravirine, including repackagers and relabelers. The FDA regulates Etravirine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Etravirine 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 Etravirine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Etravirine supplier is an individual or a company that provides Etravirine active pharmaceutical ingredient (API) or Etravirine finished formulations upon request. The Etravirine suppliers may include Etravirine API manufacturers, exporters, distributors and traders.
click here to find a list of Etravirine 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 Etravirine Drug Master File in Korea (Etravirine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Etravirine. The MFDS reviews the Etravirine KDMF as part of the drug registration process and uses the information provided in the Etravirine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Etravirine 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 Etravirine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Etravirine suppliers with KDMF on PharmaCompass.
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