01 1Daito Co., Ltd.
02 1Yoshindo Co., Ltd.
01 1Azelastine hydrochloride
02 1Day stations azelastine hydrochloride (production only)
01 2Japan
Japanese Pharmacopoeia Azelastine Hydrochloride (for manufacturing purposes only)
Registration Number : 221MF10060
Registrant's Address : 326 Yokamachi, Toyama City, Toyama Prefecture
Initial Date of Registration : 2009-03-19
Latest Date of Registration : 2009-03-19
Registration Number : 218MF10125
Registrant's Address : 3697-8 Hagishima, Fuchu-machi, Toyama City, Toyama Prefecture
Initial Date of Registration : 2006-01-30
Latest Date of Registration : 2009-11-09
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PharmaCompass offers a list of Azelastine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Azelastine Hydrochloride manufacturer or Azelastine Hydrochloride supplier for your needs.
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A Azelastine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azelastine HCl, including repackagers and relabelers. The FDA regulates Azelastine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azelastine HCl 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 Azelastine HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Azelastine HCl supplier is an individual or a company that provides Azelastine HCl active pharmaceutical ingredient (API) or Azelastine HCl finished formulations upon request. The Azelastine HCl suppliers may include Azelastine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Azelastine HCl 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 Azelastine HCl Drug Master File in Japan (Azelastine HCl JDMF) empowers Azelastine HCl 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 Azelastine HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Azelastine HCl 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 Azelastine HCl suppliers with JDMF on PharmaCompass.
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