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01 2Evonik Rexim S. A. S.
02 1Kyowa Hakko Bio Co., Ltd.
03 1Shanghai Ajinomoto Amino Acid Co., Ltd.
01 2Japanese Pharmacopoeia L- lysine hydrochloride (production only)
02 2L- lysine hydrochloride, L-Lysine Hydrochloride
01 2Germany
02 2Japan
Registration Number : 226MF10123
Registrant's Address : 33, Rue de Verdun Ham, France
Initial Date of Registration : 2014-06-18
Latest Date of Registration : 2019-07-19
Registration Number : 225MF10189
Registrant's Address : 33, Rue de Verdun Ham, France
Initial Date of Registration : 2013-10-09
Latest Date of Registration : 2013-10-09
Japanese Pharmacopoeia L-Lysine Hydrochloride (for manufacturing only)
Registration Number : 223MF10042
Registrant's Address : No. 718, Rongle East Road, Songjiang District, Shanghai, People's Republic of China
Initial Date of Registration : 2011-03-10
Latest Date of Registration : 2011-03-10
Japanese Pharmacopoeia L-Lysine Hydrochloride (for manufacturing only)
Registration Number : 224MF10009
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 L-Lysine-Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Lysine-Hydrochloride, including repackagers and relabelers. The FDA regulates L-Lysine-Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Lysine-Hydrochloride 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-Lysine-Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Lysine-Hydrochloride supplier is an individual or a company that provides L-Lysine-Hydrochloride active pharmaceutical ingredient (API) or L-Lysine-Hydrochloride finished formulations upon request. The L-Lysine-Hydrochloride suppliers may include L-Lysine-Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of L-Lysine-Hydrochloride 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-Lysine-Hydrochloride Drug Master File in Japan (L-Lysine-Hydrochloride JDMF) empowers L-Lysine-Hydrochloride 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-Lysine-Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of L-Lysine-Hydrochloride 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-Lysine-Hydrochloride suppliers with JDMF on PharmaCompass.
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