01 1Osaka Synthetic Organic Chemistry Laboratory Co., Ltd.
01 1Deferasirox manufacturing only
01 1Japan
Deferasirox Manufacturing Only
Registration Number : 231MF10012
Registrant's Address : 1-1-2 Nishinomiyahama, Nishinomiya City, Hyogo Prefecture
Initial Date of Registration : 2019-01-11
Latest Date of Registration : 2021-05-17
A Deferasirox manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Deferasirox, including repackagers and relabelers. The FDA regulates Deferasirox manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Deferasirox 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 Deferasirox manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Deferasirox supplier is an individual or a company that provides Deferasirox active pharmaceutical ingredient (API) or Deferasirox finished formulations upon request. The Deferasirox suppliers may include Deferasirox API manufacturers, exporters, distributors and traders.
click here to find a list of Deferasirox 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 Deferasirox Drug Master File in Japan (Deferasirox JDMF) empowers Deferasirox 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 Deferasirox JDMF during the approval evaluation for pharmaceutical products. At the time of Deferasirox 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 Deferasirox suppliers with JDMF on PharmaCompass.
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