AMINO has successfully registered a drug master file with the American Food and Drug Administration (FDA) for the production of L-aspartic acid.
“We are pleased to expand our US-DMF portfolio for regulated pharmaceutical applications.”, states Henrike Bertz, responsible for Regulatory Affairs at AMINO. “L-aspartic acid is one of the growing products of our broad product spectrum, hence we are pleased that this amino acid is now registered in the United States.”, adds Kai-Philipp Thomas, Marketing & Sales Director of AMINO GmbH. By registering with the FDA, AMINO is able to expand its sales further, particularly targeted at pharmaceutical companies in the U.S with the amino acid L-aspartic acid.
L-aspartic acid is a proteinogenic amino acid and is used in many pharmaceutical and nutritional products.
The company announced further that it plans to register additional amino acids with the FDA as part of its internationalization strategy. "With the construction of our new plant and the registration of our products, we intend to service the increasing demand from our existing and new customers," explains Dr. Lutz Thomas, managing director of AMINO GmbH.> Show less