01 1Derivados Quimicos sau
01 1Flutamide
01 1Spain
Registration Number : 217MF11174
Registrant's Address : Camino de Pliego, No. 150, Alcantarilla, 30820, Murcia, Spain
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2019-10-11
A Odyne manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Odyne, including repackagers and relabelers. The FDA regulates Odyne manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Odyne 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 Odyne manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Odyne supplier is an individual or a company that provides Odyne active pharmaceutical ingredient (API) or Odyne finished formulations upon request. The Odyne suppliers may include Odyne API manufacturers, exporters, distributors and traders.
click here to find a list of Odyne 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 Odyne Drug Master File in Japan (Odyne JDMF) empowers Odyne 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 Odyne JDMF during the approval evaluation for pharmaceutical products. At the time of Odyne 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 Odyne suppliers with JDMF on PharmaCompass.
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