Registration Number : 222MF10223
Registrant's Address : Great Eastern Chambers, CBD Belapur, Navi Mumbai-400 614, India
Initial Date of Registration : 2010-09-03
Latest Date of Registration : 2013-01-18
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A 1-(aminomethyl)cyclohexaneacetic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1-(aminomethyl)cyclohexaneacetic acid, including repackagers and relabelers. The FDA regulates 1-(aminomethyl)cyclohexaneacetic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1-(aminomethyl)cyclohexaneacetic acid 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 1-(aminomethyl)cyclohexaneacetic acid supplier is an individual or a company that provides 1-(aminomethyl)cyclohexaneacetic acid active pharmaceutical ingredient (API) or 1-(aminomethyl)cyclohexaneacetic acid finished formulations upon request. The 1-(aminomethyl)cyclohexaneacetic acid suppliers may include 1-(aminomethyl)cyclohexaneacetic acid 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 1-(aminomethyl)cyclohexaneacetic acid Drug Master File in Japan (1-(aminomethyl)cyclohexaneacetic acid JDMF) empowers 1-(aminomethyl)cyclohexaneacetic acid 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 1-(aminomethyl)cyclohexaneacetic acid JDMF during the approval evaluation for pharmaceutical products. At the time of 1-(aminomethyl)cyclohexaneacetic acid 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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