01 1Guerbet Ireland ULC
01 1Ioversol
01 1Ireland
Registration Number : 226MF10059
Registrant's Address : Damastown, Mulhuddart, Dublin 15 Ireland
Initial Date of Registration : 2014-03-06
Latest Date of Registration : 2014-03-06
A Ioversol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ioversol, including repackagers and relabelers. The FDA regulates Ioversol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ioversol 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 Ioversol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ioversol supplier is an individual or a company that provides Ioversol active pharmaceutical ingredient (API) or Ioversol finished formulations upon request. The Ioversol suppliers may include Ioversol API manufacturers, exporters, distributors and traders.
click here to find a list of Ioversol 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 Ioversol Drug Master File in Japan (Ioversol JDMF) empowers Ioversol 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 Ioversol JDMF during the approval evaluation for pharmaceutical products. At the time of Ioversol 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 Ioversol suppliers with JDMF on PharmaCompass.
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