The accreditation corresponds to both US Food and Drug Administration (FDA) and European Union (EU) good manufacturing practice (GMP) rules.
Budenheim, which will produce the chemical at its combined manufacturing and distribution centre near Mainz in central Germany, said that certification significantly expands the potential market for its products.
The firm went on to say that it will seek similar GMP approval for its sodium phosphate manufacturing facility in the near future in a bid to strengthen its position in the pharmaceutical excipients market.