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, Price,and more, enabling you to easily find the right Azelastine Hydrochloride manufacturer or Azelastine Hydrochloride supplier for your needs.
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PharmaCompass also assists you with knowing the Azelastine Hydrochloride API Price utilized in the formulation of products. Azelastine Hydrochloride API Price is not always fixed or binding as the Azelastine Hydrochloride Price is obtained through a variety of data sources. The Azelastine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Viatris brand of azelastine hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Viatris brand of azelastine hydrochloride, including repackagers and relabelers. The FDA regulates Viatris brand of azelastine hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Viatris brand of azelastine hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Viatris brand of azelastine hydrochloride supplier is an individual or a company that provides Viatris brand of azelastine hydrochloride active pharmaceutical ingredient (API) or Viatris brand of azelastine hydrochloride finished formulations upon request. The Viatris brand of azelastine hydrochloride suppliers may include Viatris brand of azelastine hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Viatris brand of azelastine hydrochloride 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 Viatris brand of azelastine hydrochloride Drug Master File in Japan (Viatris brand of azelastine hydrochloride JDMF) empowers Viatris brand of azelastine hydrochloride 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 Viatris brand of azelastine hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Viatris brand of azelastine hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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