01 1Shiratori Pharmaceutical Co., Ltd.
01 1Dochinrad manufacturing only
01 1Japan
Registration Number : 230MF10137
Registrant's Address : 6-11-24 Tsudanuma, Narashino City, Chiba Prefecture
Initial Date of Registration : 2018-10-01
Latest Date of Registration : 2018-10-01
A Dotinurad manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dotinurad, including repackagers and relabelers. The FDA regulates Dotinurad manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dotinurad 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 Dotinurad manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dotinurad supplier is an individual or a company that provides Dotinurad active pharmaceutical ingredient (API) or Dotinurad finished formulations upon request. The Dotinurad suppliers may include Dotinurad API manufacturers, exporters, distributors and traders.
click here to find a list of Dotinurad 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 Dotinurad Drug Master File in Japan (Dotinurad JDMF) empowers Dotinurad 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 Dotinurad JDMF during the approval evaluation for pharmaceutical products. At the time of Dotinurad 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 Dotinurad suppliers with JDMF on PharmaCompass.
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