Master File Registration

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・CEP

DMF (Japan)

L-Tyrosine L-Cysteine Acetylcysteine Ibudilast L-Cysteine Etylester Hydrochloride 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, Taiwan, Southafrica) Aminolevulinic Acid Hydrochloride (USA)

CEP(EU)

L-Tyrosine Acetylcysteine

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