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