01 1Kanto Chemical Co., Ltd.
02 1SperaNexus Inc.
03 1Tokuyama Corporation
01 1Betahistine mesylate
02 1Japanese Pharmacopoeia betahistine mesylate (production only)
03 1Mesylate betahistine
01 3Japan
Registration Number : 217MF10043
Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-20
Latest Date of Registration : 2008-06-10
Registration Number : 221MF10123
Registrant's Address : 3-2-8 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2009-06-23
Latest Date of Registration : 2016-02-29
Japanese Pharmacopoeia Betahistine Mesilate (For manufacturing only)
Registration Number : 221MF10067
Registrant's Address : 1-1 Mikage-cho, Shunan City, Yamaguchi Prefecture
Initial Date of Registration : 2009-03-26
Latest Date of Registration : 2013-08-12
A Betahistine Dimesilate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betahistine Dimesilate, including repackagers and relabelers. The FDA regulates Betahistine Dimesilate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betahistine Dimesilate 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 Betahistine Dimesilate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Betahistine Dimesilate supplier is an individual or a company that provides Betahistine Dimesilate active pharmaceutical ingredient (API) or Betahistine Dimesilate finished formulations upon request. The Betahistine Dimesilate suppliers may include Betahistine Dimesilate API manufacturers, exporters, distributors and traders.
click here to find a list of Betahistine Dimesilate 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 Betahistine Dimesilate Drug Master File in Japan (Betahistine Dimesilate JDMF) empowers Betahistine Dimesilate 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 Betahistine Dimesilate JDMF during the approval evaluation for pharmaceutical products. At the time of Betahistine Dimesilate 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 Betahistine Dimesilate suppliers with JDMF on PharmaCompass.
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