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