01 1Nippon Rika Pharmaceuticals Co., Ltd.
01 1Outsiders regulations hydrochloric acid L- ethyl tyrosine
01 1Japan
Extra-official regulation L-ethyl tyrosine hydrochloride
Registration Number : 217MF10065
Registrant's Address : 2-2 Nihonbashi Honcho 4-chome, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-20
Latest Date of Registration : 2009-09-24
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A L-Tyrosine Ethyl Ester Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Tyrosine Ethyl Ester Hydrochloride, including repackagers and relabelers. The FDA regulates L-Tyrosine Ethyl Ester Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Tyrosine Ethyl Ester Hydrochloride 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 L-Tyrosine Ethyl Ester Hydrochloride supplier is an individual or a company that provides L-Tyrosine Ethyl Ester Hydrochloride active pharmaceutical ingredient (API) or L-Tyrosine Ethyl Ester Hydrochloride finished formulations upon request. The L-Tyrosine Ethyl Ester Hydrochloride suppliers may include L-Tyrosine Ethyl Ester Hydrochloride 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 L-Tyrosine Ethyl Ester Hydrochloride Drug Master File in Japan (L-Tyrosine Ethyl Ester Hydrochloride JDMF) empowers L-Tyrosine Ethyl Ester Hydrochloride 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 L-Tyrosine Ethyl Ester Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of L-Tyrosine Ethyl Ester Hydrochloride 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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