01 1Osaka Synthetic Organic Chemistry Laboratory Co., Ltd.
01 1Japanese Pharmacopoeia bromide Chimepijiumu production dedicated
01 1Japan
Japanese Pharmacopoeia Timepidium Bromide Hydrate For manufacturing purposes only
Registration Number : 218MF10686
Registrant's Address : 1-1-2 Nishinomiyahama, Nishinomiya City, Hyogo Prefecture
Initial Date of Registration : 2006-08-11
Latest Date of Registration : 2006-08-11
A Timepidium Bromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Timepidium Bromide, including repackagers and relabelers. The FDA regulates Timepidium Bromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Timepidium Bromide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Timepidium Bromide supplier is an individual or a company that provides Timepidium Bromide active pharmaceutical ingredient (API) or Timepidium Bromide finished formulations upon request. The Timepidium Bromide suppliers may include Timepidium Bromide API manufacturers, exporters, distributors and traders.
click here to find a list of Timepidium Bromide 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 Timepidium Bromide Drug Master File in Japan (Timepidium Bromide JDMF) empowers Timepidium Bromide 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 Timepidium Bromide JDMF during the approval evaluation for pharmaceutical products. At the time of Timepidium Bromide 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 Timepidium Bromide suppliers with JDMF on PharmaCompass.
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