01 1Synergy Health Ede BV@Janssen Pharmaceutica NV@Janssen Pharmaceutical Sciences Unlimited Company
01 1Korea Janssen Co., Ltd.
01 1Rilpivirine
01 1U.S.A
Registrant Name : Korea Janssen Co., Ltd.
Registration Date : 2021-11-08
Registration Number : Su81-25-ND
Manufacturer Name : Synergy Health Ede BV@Jansse...
Manufacturer Address : Soevereinstraat 2, Etten-Leur 4879NN, Netherlands@Janssen Pharmaceuticalaan 3, Geel, ...
A Rilpivirine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rilpivirine, including repackagers and relabelers. The FDA regulates Rilpivirine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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 Rilpivirine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rilpivirine supplier is an individual or a company that provides Rilpivirine active pharmaceutical ingredient (API) or Rilpivirine finished formulations upon request. The Rilpivirine suppliers may include Rilpivirine API manufacturers, exporters, distributors and traders.
click here to find a list of 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 Rilpivirine Drug Master File in Korea (Rilpivirine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rilpivirine. The MFDS reviews the Rilpivirine KDMF as part of the drug registration process and uses the information provided in the Rilpivirine KDMF to evaluate the safety and efficacy of the drug.
After submitting a 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 Rilpivirine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rilpivirine suppliers with KDMF on PharmaCompass.
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