01 1Sicor Societa (') Italiana Corticosteroidi S. r. l.
01 1Mitomycin C
01 1Italy
Registration Number : 304MF10010
Registrant's Address : Piazzale Luigi Cadorna, 4 - 20123 MILANO, Italy
Initial Date of Registration : 2022-01-11
Latest Date of Registration : 2024-02-14
A Mitomycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mitomycin, including repackagers and relabelers. The FDA regulates Mitomycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mitomycin 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 Mitomycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mitomycin supplier is an individual or a company that provides Mitomycin active pharmaceutical ingredient (API) or Mitomycin finished formulations upon request. The Mitomycin suppliers may include Mitomycin API manufacturers, exporters, distributors and traders.
click here to find a list of Mitomycin 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 Mitomycin Drug Master File in Japan (Mitomycin JDMF) empowers Mitomycin 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 Mitomycin JDMF during the approval evaluation for pharmaceutical products. At the time of Mitomycin 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 Mitomycin suppliers with JDMF on PharmaCompass.
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