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 purposes 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 purposes 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
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PharmaCompass offers a list of Dl-Histidine Monohydrochloride Monohydrate 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 Dl-Histidine Monohydrochloride Monohydrate manufacturer or Dl-Histidine Monohydrochloride Monohydrate supplier for your needs.
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PharmaCompass also assists you with knowing the Dl-Histidine Monohydrochloride Monohydrate API Price utilized in the formulation of products. Dl-Histidine Monohydrochloride Monohydrate API Price is not always fixed or binding as the Dl-Histidine Monohydrochloride Monohydrate Price is obtained through a variety of data sources. The Dl-Histidine Monohydrochloride Monohydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A L-Histidine monohydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Histidine monohydrochloride, including repackagers and relabelers. The FDA regulates L-Histidine monohydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Histidine monohydrochloride 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 L-Histidine monohydrochloride supplier is an individual or a company that provides L-Histidine monohydrochloride active pharmaceutical ingredient (API) or L-Histidine monohydrochloride finished formulations upon request. The L-Histidine monohydrochloride suppliers may include L-Histidine monohydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of L-Histidine monohydrochloride 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 monohydrochloride Drug Master File in Japan (L-Histidine monohydrochloride JDMF) empowers L-Histidine monohydrochloride 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 monohydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of L-Histidine monohydrochloride 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 monohydrochloride suppliers with JDMF on PharmaCompass.
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