01 2meito Co., Ltd.
01 1Dextran 40
02 1Dextran sulfate sodium sulfur 18
01 2Japan
Registration Number : 217MF11169
Registrant's Address : 41, 2-chome, Sasazuka-cho, Nishi-ku, Nagoya City, Aichi Prefecture
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2018-10-01
Dextran sulfate sodium sulfur 18
Registration Number : 218MF10826
Registrant's Address : 2-41 Sasazuka-cho, Nishi-ku, Nagoya City, Aichi Prefecture
Initial Date of Registration : 2006-10-20
Latest Date of Registration : 2006-10-20
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A Rondex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rondex, including repackagers and relabelers. The FDA regulates Rondex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rondex 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 Rondex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Rondex supplier is an individual or a company that provides Rondex active pharmaceutical ingredient (API) or Rondex finished formulations upon request. The Rondex suppliers may include Rondex API manufacturers, exporters, distributors and traders.
click here to find a list of Rondex suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Rondex Drug Master File in Japan (Rondex JDMF) empowers Rondex 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 Rondex JDMF during the approval evaluation for pharmaceutical products. At the time of Rondex 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 Rondex suppliers with JDMF on PharmaCompass.
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