01 1Alps Pharmaceutical Co., Ltd.
01 1Japanese Pharmacopoeia Butoropiumu bromide
01 1Japan
Japanese Pharmacopoeia Butropium Bromide
Registration Number : 221MF10173
Registrant's Address : 2-10-50 Mukaimachi, Furukawa-cho, Hida-shi, Gifu Prefecture
Initial Date of Registration : 2009-07-30
Latest Date of Registration : 2009-07-30
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PharmaCompass also assists you with knowing the Tiotropium Bromide API Price utilized in the formulation of products. Tiotropium Bromide API Price is not always fixed or binding as the Tiotropium Bromide Price is obtained through a variety of data sources. The Tiotropium Bromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A SPIRIVA RESPIMAT manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SPIRIVA RESPIMAT, including repackagers and relabelers. The FDA regulates SPIRIVA RESPIMAT manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SPIRIVA RESPIMAT 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 SPIRIVA RESPIMAT supplier is an individual or a company that provides SPIRIVA RESPIMAT active pharmaceutical ingredient (API) or SPIRIVA RESPIMAT finished formulations upon request. The SPIRIVA RESPIMAT suppliers may include SPIRIVA RESPIMAT API manufacturers, exporters, distributors and traders.
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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 SPIRIVA RESPIMAT Drug Master File in Japan (SPIRIVA RESPIMAT JDMF) empowers SPIRIVA RESPIMAT 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 SPIRIVA RESPIMAT JDMF during the approval evaluation for pharmaceutical products. At the time of SPIRIVA RESPIMAT 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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