01 1Janssen Pharmaceutica NV
02 1Janssen Pharmaceutical Sciences Unlimited Company
01 2Rirupibirin hydrochloride
01 2U.S.A
Registration Number : 229MF10184
Registrant's Address : Turnhoutseweg 30 B-2340 Beerse Belgium
Initial Date of Registration : 2017-10-06
Latest Date of Registration : 2017-10-06
Registration Number : 229MF10183
Registrant's Address : Little Island Industrial Estate, Little Island, Co. Cork, Ireland
Initial Date of Registration : 2017-10-06
Latest Date of Registration : 2021-07-09
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, COA and API Price 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, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Edurant Drug Master File in Japan (Edurant JDMF) empowers Edurant API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Edurant JDMF during the approval evaluation for pharmaceutical products. At the time of Edurant JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Edurant suppliers with JDMF on PharmaCompass.
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