01 1Ajinomoto Co., Inc.
02 1Kyowa Hakko Bio Co., Ltd.
01 2Japanese Pharmacopoeia L- arginine (production only)
01 2Japan
Japanese Pharmacopoeia L-Arginine (for manufacturing only)
Registration Number : 218MF10640
Registrant's Address : 1-15-1 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2006-07-20
Latest Date of Registration : 2006-07-20
Japanese Pharmacopoeia L-Arginine (for manufacturing only)
Registration Number : 218MF10702
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2006-08-11
Latest Date of Registration : 2008-03-14
A L-Arginine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Arginine, including repackagers and relabelers. The FDA regulates L-Arginine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Arginine 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-Arginine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Arginine supplier is an individual or a company that provides L-Arginine active pharmaceutical ingredient (API) or L-Arginine finished formulations upon request. The L-Arginine suppliers may include L-Arginine API manufacturers, exporters, distributors and traders.
click here to find a list of L-Arginine 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-Arginine Drug Master File in Japan (L-Arginine JDMF) empowers L-Arginine 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-Arginine JDMF during the approval evaluation for pharmaceutical products. At the time of L-Arginine 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-Arginine suppliers with JDMF on PharmaCompass.
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