01 1Janssen Pharmaceutical Sciences Unlimited Company
01 1Janssen Korea Co., Ltd.
01 1rilpivirine hydrochloride
01 1U.S.A
Registrant Name : Janssen Korea Co., Ltd.
Registration Date : 2011-10-28
Registration Number : Su217-14-ND
Manufacturer Name : Janssen Pharmaceutical Scien...
Manufacturer Address : Little Island Industrial EST., Little Island, Co. Cork, Ireland_x000D_
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A Edurant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Edurant, including repackagers and relabelers. The FDA regulates Edurant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Edurant 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 Edurant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Edurant supplier is an individual or a company that provides Edurant active pharmaceutical ingredient (API) or Edurant finished formulations upon request. The Edurant suppliers may include Edurant API manufacturers, exporters, distributors and traders.
click here to find a list of Edurant suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Edurant Drug Master File in Korea (Edurant KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Edurant. The MFDS reviews the Edurant KDMF as part of the drug registration process and uses the information provided in the Edurant KDMF to evaluate the safety and efficacy of the drug.
After submitting a Edurant 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 Edurant API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Edurant suppliers with KDMF on PharmaCompass.
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