01 1Roman Industries Co., Ltd.
01 1Ribarabin
01 1Japan
Registration Number : 217MF10488
Registrant's Address : 1-10-4 Fukuura, Kanazawa-ku, Yokohama, Kanagawa Prefecture
Initial Date of Registration : 2005-09-06
Latest Date of Registration : 2009-09-04
A Ribavarin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ribavarin, including repackagers and relabelers. The FDA regulates Ribavarin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ribavarin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Ribavarin supplier is an individual or a company that provides Ribavarin active pharmaceutical ingredient (API) or Ribavarin finished formulations upon request. The Ribavarin suppliers may include Ribavarin API manufacturers, exporters, distributors and traders.
click here to find a list of Ribavarin 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 Ribavarin Drug Master File in Japan (Ribavarin JDMF) empowers Ribavarin 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 Ribavarin JDMF during the approval evaluation for pharmaceutical products. At the time of Ribavarin 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 Ribavarin suppliers with JDMF on PharmaCompass.
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