01 1Ajinomoto Co., Inc.
02 3Nippon Rika Pharmaceuticals Co., Ltd.
03 1SAFC Biosciences, Inc.
04 1Sigma-Aldrich Company Limited Trading As SAFC
01 1Japanese Pharmacopoeia L- Tyrosine (production only)
02 2Japanese Pharmacopoeia L- tyrosine
03 2Medium/medium additive R7B-2 w/o L-Tyrosine
04 1Outsiders regulations L- tyrosine
01 4Japan
02 2U.S.A
Japanese Pharmacopoeia L-Tyrosine (for manufacturing only)
Registration Number : 226MF10025
Registrant's Address : 1-15-1 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2014-02-05
Latest Date of Registration : 2014-02-05
Japanese Pharmacopoeia L-Tyrosine
Registration Number : 224MF10026
Registrant's Address : 2-2 Nihonbashi Honcho 4-chome, Chuo-ku, Tokyo
Initial Date of Registration : 2012-02-01
Latest Date of Registration : 2012-02-01
Extra-official regulations L-tyrosine
Registration Number : 217MF10059
Registrant's Address : 4-2-2 Nihonbashi Honcho, Chuo Ward, Tokyo
Initial Date of Registration : 2005-05-20
Latest Date of Registration : 2006-10-06
Japanese Pharmacopoeia L-Tyrosine
Registration Number : 219MF10337
Registrant's Address : 2-2 Nihonbashi Honcho 4-chome, Chuo-ku, Tokyo
Initial Date of Registration : 2007-11-21
Latest Date of Registration : 2007-11-21
Medium/Medium additives・R7B-2 w/o L-Tyrosine
Registration Number : 304MF40022
Registrant's Address : 13804 West 107th Street Lenexa, Kansas 66215 USA
Initial Date of Registration : 2022-05-18
Latest Date of Registration : 2022-05-18
Medium/Medium additives・R7B-2 w/o L-Tyrosine
Registration Number : 304MF40021
Registrant's Address : Second Avenue Heatherhouse Industrial Estate Irvine, Scotland, United Kingdom KA12 8N...
Initial Date of Registration : 2022-05-18
Latest Date of Registration : 2022-05-18
A L-Tyrosine API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Tyrosine API, including repackagers and relabelers. The FDA regulates L-Tyrosine API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Tyrosine API 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 L-Tyrosine API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Tyrosine API supplier is an individual or a company that provides L-Tyrosine API active pharmaceutical ingredient (API) or L-Tyrosine API finished formulations upon request. The L-Tyrosine API suppliers may include L-Tyrosine API API manufacturers, exporters, distributors and traders.
click here to find a list of L-Tyrosine API 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 L-Tyrosine API Drug Master File in Japan (L-Tyrosine API JDMF) empowers L-Tyrosine API 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 API JDMF during the approval evaluation for pharmaceutical products. At the time of L-Tyrosine API 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 L-Tyrosine API suppliers with JDMF on PharmaCompass.
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