BioAmber launches a pharmaceutical grade for its bio-succinic acid
June 19, 2017 - BioAmber Inc. has launched BIO-SA pharmaceutical grade. This new grade of material provides a USP/NF and FCC Grade of bio-succinic acid manufactured under the United States Food and Drug Administration's (FDA) good manufacturing practices (GMP) for food and Excipients.
The United States Pharmacopeia (USP), the National Formulary (NF), and the Food Chemicals Codex (FCC) are the public pharmacopeia standards for medicines, food ingredients, dietary supplement products, and ingredients.
These standards are used by regulatory agencies and manufacturers to ensure products are of the appropriate identity, strength, quality, purity and consistency.
“Having met the stringent requirements contained in the NF and FCC reflects BioAmber’s continued dedication to quality through our best-in-class production and purification processes. By achieving this new benchmark, our global customers in the food, pharmaceutical and dietary supplement industries can be assured BioAmber’s facility adheres to the rigorous quality control standards set by the United States Food and Drug Administration (FDA).” said Fabrice Orecchioni, BioAmber’s president and COO. “This grade will allow BioAmber to supply these high-value industries with commercial volumes of an FDA regulated bio-succinic acid, a grade previously unavailable to these markets before today”, he added.