Audit # JA-568
Region Asia
Standards API/Excipients
Company Kyowa Hakko Bio Co., Ltd (Hofu Plant)
Location Yamaguchi, Japan
Date 6-7 August 2015
Materials Excipient:;-Histidine USP/EP/JP;- L-alanine, injectable (RM37831);- L-arginine, injectable (RMB2066);- L-arginine monohydrochloride, injectable;(RMB2067);- L-asparagine monohydrate, injectable;(RMB2068);- L-aspartic acid, injectable (RM37832),;- L-glutamic acid, anhydrous, injectable;(RMB2077);- L-histidine, injectable (RMB2080);- L-histidine monohydrochloride;monohydrate, injectable (RMB2081);- L-Histidine, MonoHCI, Monohydrate, EP;- L-isoleucine,media grade (RMB2082);- L-leucine,media grade (RMB2083);- L-lysine monohydrochloride, injectable;(RMB2084);- L-methionine, injectable (RMB2085);- L-phenylalanine,media grade (RMB2086);- L-threonine, injectable (RMB2089);- L-tryptophan,media grade (RMB2092);- L-tyrosine, injectable (RMB2093);- L-valine, injectable (RMB2095);- L- Histidine;- L-Histid ine, USP/EP;- L-Arginine Hydrochloride, USP;Raw Material/ Basic Chemicals;- L- Leucine;- L-arginine Merck 1.01587 10Kg LSA;- L- Histidine;- Valine;- L-Asparagine, Monohydrate; API:;-Amino Acid Mixture C;-Phenylalanine;-Tryptophan;- L-Ornithine L-Aspartate (Ornithine Aspartate);-Amino Acid Blend F;- L-Aianyi-L-Giutamine (injection grade);

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