Registration Number : 224MF10186
Registrant's Address : 8145 Blazer Drive, Wilmington, DE, 19808, United States
Initial Date of Registration : 2012-09-03
Latest Date of Registration : 2023-07-05
A Mitotane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mitotane, including repackagers and relabelers. The FDA regulates Mitotane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mitotane 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 Mitotane manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mitotane supplier is an individual or a company that provides Mitotane active pharmaceutical ingredient (API) or Mitotane finished formulations upon request. The Mitotane suppliers may include Mitotane API manufacturers, exporters, distributors and traders.
click here to find a list of Mitotane 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 Mitotane Drug Master File in Japan (Mitotane JDMF) empowers Mitotane 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 Mitotane JDMF during the approval evaluation for pharmaceutical products. At the time of Mitotane 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 Mitotane suppliers with JDMF on PharmaCompass.
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