Merck KGaA pigments get FDA approval
Merck KGaA has received approval from the US Food and Drug Association (FDA) for the safe use of Candurin pigments in oral pharmaceutical preparations.
Merck KGaA has received approval from the US Food and Drug Association (FDA) for the safe use of Candurin pigments in oral pharmaceutical preparations.
Candurin pigments are the only mica-based pearl effect pigments approved by FDA for oral applications, and are produced in compliance with Good Manufacturing Practices (GMPs), meeting the strict quality and safety requirements of the pharma industry.
Merck says that the FDA approval of Candurin pigments "will also have an international impact outside the USA", suggesting that other countries may follow FDA's example.
The pearl lustre effect achievable with Candurin can help reduce multi-medication errors, increase anti-counterfeiting properties, and improve brand differentiation and customer recognition, Merck claims.
The Candurin range is comprised of 16 pigments, all containing the natural mineral mica, which is then coated with approved colorants titanium dioxide and/or iron oxide, which can be combined to produce a variety of desired colour effects.