01 1ERREGIERRE S. p. A.
01 1Nitric acid isoconazole
01 1Italy
Registration Number : 217MF10587
Registrant's Address : VIA F. BARACCA 19-24060 SAN PAOLO D'ARGON (BERGAMO) ITALY
Initial Date of Registration : 2005-09-14
Latest Date of Registration : 2021-06-01
A Isoconazole Nitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isoconazole Nitrate, including repackagers and relabelers. The FDA regulates Isoconazole Nitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isoconazole Nitrate 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 Isoconazole Nitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isoconazole Nitrate supplier is an individual or a company that provides Isoconazole Nitrate active pharmaceutical ingredient (API) or Isoconazole Nitrate finished formulations upon request. The Isoconazole Nitrate suppliers may include Isoconazole Nitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Isoconazole Nitrate 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 Isoconazole Nitrate Drug Master File in Japan (Isoconazole Nitrate JDMF) empowers Isoconazole Nitrate 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 Isoconazole Nitrate JDMF during the approval evaluation for pharmaceutical products. At the time of Isoconazole Nitrate 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 Isoconazole Nitrate suppliers with JDMF on PharmaCompass.
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