01 1Ajinomoto Health & Nutrition North America, Inc.
02 1Kamiishiwa Anko Acid Co., Ltd.
03 1Kyowa Hakko Bio Co., Ltd.
01 3Japanese Pharmacopoeia L- histidine (production only)
01 2Japan
02 1Blank
Japanese Pharmacopoeia L-Histidine (for manufacturing only)
Registration Number : 224MF10006
Registrant's Address : 4020 Ajinomoto Drive Raleigh, North Carolina 27610, USA
Initial Date of Registration : 2012-01-18
Latest Date of Registration : 2012-01-18
Japanese Pharmacopoeia L-Histidine (for manufacturing only)
Registration Number : 224MF10011
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2012-01-18
Latest Date of Registration : 2012-01-18
Japanese Pharmacopoeia L-Histidine (for manufacturing only)
Registration Number : 229MF10078
Registrant's Address : No. 158, Xinduan Road, Gongyuan District, Qingpu, Shanghai City, China
Initial Date of Registration : 2017-04-11
Latest Date of Registration : 2017-04-11
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A L-Histidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Histidine, including repackagers and relabelers. The FDA regulates L-Histidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Histidine 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-Histidine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Histidine supplier is an individual or a company that provides L-Histidine active pharmaceutical ingredient (API) or L-Histidine finished formulations upon request. The L-Histidine suppliers may include L-Histidine API manufacturers, exporters, distributors and traders.
click here to find a list of L-Histidine 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-Histidine Drug Master File in Japan (L-Histidine JDMF) empowers L-Histidine 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-Histidine JDMF during the approval evaluation for pharmaceutical products. At the time of L-Histidine 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-Histidine suppliers with JDMF on PharmaCompass.
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