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
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A 3-(Di-2-thienylmethylene)-5-methoxy-1,1-dimethyl-piperidinium bromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 3-(Di-2-thienylmethylene)-5-methoxy-1,1-dimethyl-piperidinium bromide, including repackagers and relabelers. The FDA regulates 3-(Di-2-thienylmethylene)-5-methoxy-1,1-dimethyl-piperidinium bromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 3-(Di-2-thienylmethylene)-5-methoxy-1,1-dimethyl-piperidinium 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 3-(Di-2-thienylmethylene)-5-methoxy-1,1-dimethyl-piperidinium bromide supplier is an individual or a company that provides 3-(Di-2-thienylmethylene)-5-methoxy-1,1-dimethyl-piperidinium bromide active pharmaceutical ingredient (API) or 3-(Di-2-thienylmethylene)-5-methoxy-1,1-dimethyl-piperidinium bromide finished formulations upon request. The 3-(Di-2-thienylmethylene)-5-methoxy-1,1-dimethyl-piperidinium bromide suppliers may include 3-(Di-2-thienylmethylene)-5-methoxy-1,1-dimethyl-piperidinium bromide 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 3-(Di-2-thienylmethylene)-5-methoxy-1,1-dimethyl-piperidinium bromide Drug Master File in Japan (3-(Di-2-thienylmethylene)-5-methoxy-1,1-dimethyl-piperidinium bromide JDMF) empowers 3-(Di-2-thienylmethylene)-5-methoxy-1,1-dimethyl-piperidinium 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 3-(Di-2-thienylmethylene)-5-methoxy-1,1-dimethyl-piperidinium bromide JDMF during the approval evaluation for pharmaceutical products. At the time of 3-(Di-2-thienylmethylene)-5-methoxy-1,1-dimethyl-piperidinium bromide 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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