01 1Ajinomoto Health & Nutrition North America, Inc.
02 1Kyowa Hakko Bio Co., Ltd.
01 2Japanese Pharmacopoeia L- histidine hydrochloride hydrate (production only)
01 2Japan
Japanese Pharmacopoeia L-Histidine Hydrochloride Hydrate (for manufacturing only)
Registration Number : 224MF10005
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 Hydrochloride Hydrate (for manufacturing only)
Registration Number : 224MF10014
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2012-01-18
Latest Date of Registration : 2012-01-18
A Dl-Histidine Monohydrochloride Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dl-Histidine Monohydrochloride Monohydrate, including repackagers and relabelers. The FDA regulates Dl-Histidine Monohydrochloride Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dl-Histidine Monohydrochloride Monohydrate 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 Dl-Histidine Monohydrochloride Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dl-Histidine Monohydrochloride Monohydrate supplier is an individual or a company that provides Dl-Histidine Monohydrochloride Monohydrate active pharmaceutical ingredient (API) or Dl-Histidine Monohydrochloride Monohydrate finished formulations upon request. The Dl-Histidine Monohydrochloride Monohydrate suppliers may include Dl-Histidine Monohydrochloride Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Dl-Histidine Monohydrochloride Monohydrate 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 Dl-Histidine Monohydrochloride Monohydrate Drug Master File in Japan (Dl-Histidine Monohydrochloride Monohydrate JDMF) empowers Dl-Histidine Monohydrochloride Monohydrate 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 Dl-Histidine Monohydrochloride Monohydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Dl-Histidine Monohydrochloride Monohydrate 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 Dl-Histidine Monohydrochloride Monohydrate suppliers with JDMF on PharmaCompass.
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