01 1Curia Spain S. A. U.
01 1Mifepristone micronized
01 1U.S.A
Registration Number : 302MF10146
Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain
Initial Date of Registration : 2020-12-15
Latest Date of Registration : 2020-12-15
A Mifepristone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mifepristone, including repackagers and relabelers. The FDA regulates Mifepristone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mifepristone 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 Mifepristone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mifepristone supplier is an individual or a company that provides Mifepristone active pharmaceutical ingredient (API) or Mifepristone finished formulations upon request. The Mifepristone suppliers may include Mifepristone API manufacturers, exporters, distributors and traders.
click here to find a list of Mifepristone 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 Mifepristone Drug Master File in Japan (Mifepristone JDMF) empowers Mifepristone 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 Mifepristone JDMF during the approval evaluation for pharmaceutical products. At the time of Mifepristone 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 Mifepristone suppliers with JDMF on PharmaCompass.
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