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 Mesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betahistine Mesylate, including repackagers and relabelers. The FDA regulates Betahistine Mesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betahistine Mesylate 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 Mesylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Betahistine Mesylate supplier is an individual or a company that provides Betahistine Mesylate active pharmaceutical ingredient (API) or Betahistine Mesylate finished formulations upon request. The Betahistine Mesylate suppliers may include Betahistine Mesylate API manufacturers, exporters, distributors and traders.
click here to find a list of Betahistine Mesylate 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 Mesylate Drug Master File in Japan (Betahistine Mesylate JDMF) empowers Betahistine Mesylate 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 Mesylate JDMF during the approval evaluation for pharmaceutical products. At the time of Betahistine Mesylate 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 Mesylate suppliers with JDMF on PharmaCompass.
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