Registration Number : 221MF10003
Registrant's Address : Kaiser-Wilhelm-Allee 1,51373 Leverkusen, Germany
Initial Date of Registration : 2009-01-13
Latest Date of Registration : 2009-01-13
A Iopromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iopromide, including repackagers and relabelers. The FDA regulates Iopromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iopromide 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 Iopromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Iopromide supplier is an individual or a company that provides Iopromide active pharmaceutical ingredient (API) or Iopromide finished formulations upon request. The Iopromide suppliers may include Iopromide API manufacturers, exporters, distributors and traders.
click here to find a list of Iopromide 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 Iopromide Drug Master File in Japan (Iopromide JDMF) empowers Iopromide 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 Iopromide JDMF during the approval evaluation for pharmaceutical products. At the time of Iopromide 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 Iopromide suppliers with JDMF on PharmaCompass.
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