01 1Bussan Food Science Co., Ltd.
02 1Mitsubishi Corporation Life Sciences Ltd.
01 1Japanese Pharmacopoeia xylitol
02 1Xylitol
01 2Japan
Japanese Pharmacopoeia Xylitol
Registration Number : 218MF10313
Registrant's Address : 24-12 Kitahama-cho, Chita City, Aichi Prefecture
Initial Date of Registration : 2006-02-28
Latest Date of Registration : 2006-02-28
Registration Number : 217MF10326
Registrant's Address : 1-1-3 Yurakucho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-07-14
Latest Date of Registration : 2006-03-24
A Xylitol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Xylitol, including repackagers and relabelers. The FDA regulates Xylitol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Xylitol 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 Xylitol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Xylitol supplier is an individual or a company that provides Xylitol active pharmaceutical ingredient (API) or Xylitol finished formulations upon request. The Xylitol suppliers may include Xylitol API manufacturers, exporters, distributors and traders.
click here to find a list of Xylitol 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 Xylitol Drug Master File in Japan (Xylitol JDMF) empowers Xylitol 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 Xylitol JDMF during the approval evaluation for pharmaceutical products. At the time of Xylitol 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 Xylitol suppliers with JDMF on PharmaCompass.
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