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
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PharmaCompass offers a list of L-Arginine API API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right L-Arginine API manufacturer or L-Arginine API supplier for your needs.
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A (2S)-2-amino-5-guanidinopentanoic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (2S)-2-amino-5-guanidinopentanoic acid, including repackagers and relabelers. The FDA regulates (2S)-2-amino-5-guanidinopentanoic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (2S)-2-amino-5-guanidinopentanoic 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 (2S)-2-amino-5-guanidinopentanoic acid supplier is an individual or a company that provides (2S)-2-amino-5-guanidinopentanoic acid active pharmaceutical ingredient (API) or (2S)-2-amino-5-guanidinopentanoic acid finished formulations upon request. The (2S)-2-amino-5-guanidinopentanoic acid suppliers may include (2S)-2-amino-5-guanidinopentanoic 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 (2S)-2-amino-5-guanidinopentanoic acid Drug Master File in Japan ((2S)-2-amino-5-guanidinopentanoic acid JDMF) empowers (2S)-2-amino-5-guanidinopentanoic 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 (2S)-2-amino-5-guanidinopentanoic acid JDMF during the approval evaluation for pharmaceutical products. At the time of (2S)-2-amino-5-guanidinopentanoic 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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We have 2 companies offering (2S)-2-amino-5-guanidinopentanoic acid
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