• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

ADDING MULTIMEDIA EMD Chemicals Inc. Achieves FDA Approval for Its Candurin(R) Pearl Effect Colors for Use in Drugs

Posted on: Wednesday, 26 July 2006, 18:00 CDT

EMD Chemicals Inc., the North American specialty chemicals affiliate of Merck KGaA, Darmstadt, Germany, has announced it will begin marketing its patent-pending Candurin(R) Pearl Effect Colors to the pharmaceutical industry in the United States. This comes upon the heels of learning that the United States Food and Drug Administration has published a Notice of Effectiveness on the final ruling concerning mica-based pearlescent pigments as of July 20, 2006.

This is a significant accomplishment in the world of color additives and represents the culmination of over eight years of hard work by company associates. This new regulation allows for the use of Candurin(R) Pearl Effect Colors as color additives in ingested drugs (tablets, capsules and oral suspensions) in levels up to 3% of the final product weight. The complete regulation may be viewed on the FDA's website (www.fda.gov under the Code of Federal Regulations, 21 CFR, Part 73, subpart B, Section 73.1128).

Candurin(R) Pearl Effect Colors are available in a vibrant range of colors including: silver white, interference, gold, bronze and red. Used alone or in combination with other approved color additives, Candurin(R) Pearl Effect Colors can help drug formulators achieve an endless variety of exquisite pearl effects for their pharmaceutical products. The unique effects produced by the incorporation of Candurin(R) Pearl Effect Colors in drug products provides the consumer with an extra measure of safety against medication errors while giving the manufacturer a product with a distinctive brand identity that is not easily imitated.

Rigorously tested, proven safe and made under cGMP conditions, these pigments are very easy to work with due to their stability at high temperatures, acid/alkali resistance, neutral taste and insoluble nature. The low use levels required to achieve their color effects also make Candurin(R) Pearl Effect Colors an economical choice for pharmaceutical formulations.

Francois Marchio, Senior Vice President Pigments, sees the FDA approval as proof of EMD's commitment to innovation in pigments and credits this success to a strong team of dedicated individuals within EMD and its parent company Merck KGaA, Darmstadt Germany. " I congratulate in particular the U.S. team led by Dan Giambattisto for its efforts that have spanned more than eight years."

About EMD Chemicals

EMD Chemicals represents the North American chemical sector of Merck KGaA, Darmstadt, Germany. As an international organization with 1,100 employees and revenues of approx. $US 400 million, EMD Chemicals focuses on innovative specialty chemicals for pharmaceutical, biotech, cosmetic, agricultural, coatings, plastics, electronics and other industrial applications

About Merck KGaA

Merck KGaA, Darmstadt, Germany is a global pharmaceutical and chemical company with sales of EUR 5.9 billion in 2005, a history that began in 1668, and a future shaped by 29,133 employees in 54 countries. The former U.S. subsidiary, Merck & Co., has been completely independent of the Merck Group since 1917.

Source: Business Wire

More News in this Category