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Master File  Registration

Drug Master Files and Certificate of suitability of Monographs for the Europian Pharmacopoeia

The means by which the data related to the manufacture of an active pharmaceutical ingredient (API) – data about the ingredient’s materials, manufacturing, processing, packaging, storage, quality, etc. – is registered in advance with regulatory authorities is called a Drug Master File (DMF). Our company submits DMFs not only in Japan but also in other countries throughout the world, especially in the West.  
 
DMF (Japan)
 
Japanese Pharmacopoeia (JP)
・L-Tyrosine
・L-Cysteine
・Acetylcysteine
・Ibudilast
・L-Cysteine Etylester Hydrochloride
 
Japanese Pharmaceutical Codex (JPC)
・L-Cysteine Malate
・L-Methylcysteine Hydrochloride
・L-Ethyltyrosine Hydrochloride
 
 
 
DMF (Other)
 
・L-Tyrosine (USA, Republic of Korea, Australia, UK, etc)
・Acetylcysteine  (USA, Republic of Korea, Southafrica)
・Aminolevulinic Acid Hydrochloride (USA)
 
 
 
CEP (EU)
 
・L-Tyrosine
・Acetylcysteine
 
 
 
CEP (L-Tyrosine)

CEP (Acetylcysteine)
 
Certificate of GMP Factory by Japanese Regulatory agency

Certificate of GMP Factory
by Japanese Regulatory agency