Kollicoat® IR now listed in the FDA’s Inactive Ingredient Database

FLORHAM PARK, NJ, December 3, 2015 - BASF’s multifunctional pharmaceutical excipient Kollicoat^® IR is listed on the Inactive Ingredient Database (IID) of the U.S. Food and Drug Administration (FDA).

Kollicoat® IR is a robust, yet flexible, polyvinyl alcohol-polyethylene glycol graft copolymer used for a variety of functional applications, such as instant release coating and peroxide-free binding. It was specifically designed to fulfill the highest performance, quality and safety standards.

In addition to being monographed in all major markets, Kollicoat® IR has received key registrations and listings in the pharmaceutical and dietary supplements industries; which is of increasing importance to these industries.

“Over the past few years many BASF partners have developed superior formulations based on the Kollicoat^® IR platform,” said Daniele Piergentili, Vice President Global Marketing and R&D at BASF. “Its listing on the IID represents a major regulatory milestone for BASF and for all the formulators who benefit from the unique properties of this polymer”.

• Major monographies and registrations
• Ph. Eur.(Macrogol Poly(Vinyl alcohol) Grafted Copolymer)
• USP-NF(Ethylene Gylcol and Vinyl Alcohol Graft Copolymer)
• JPE (Polyvinyl Alcohol-Polyethylene Glycol Graft Copolymer)
• IID listing (Polyvinyl Alcohol Graft Polyethylene Glycol Copolymer (3:1; 45000 MW))
• Self-affirmed Generally Regarded As Safe (GRAS)

Kollicoat^® IR is an ideal water-soluble film former for manufacturing instant-release coatings for solid dosage forms. Its low viscosity and flexibility allows processing at both low temperatures as well as high solids content, while always delivering optimal coating results. Kollicoat^® IR uniquely combines no peroxide formation with very strong binding capacity for solid oral dosage, comparable with classic polyvinylpyrrolidon (PVP). In addition, its comparably low viscosity makes it easy to process, even when a high binder percentage is used.

About BASF

BASF Corporation, headquartered in Florham Park, New Jersey, is the North American affiliate of BASF SE, Ludwigshafen, Germany. BASF has more than 17,000 employees in North America, and had sales of $20.6 billion in 2014. For more information about BASF’s North American operations, visit www.basf.us.

At BASF, we create chemistry – and have been doing so for 150 years. Our portfolio ranges from chemicals, plastics, performance products and crop protection products to oil and gas. As the world’s leading chemical company, we combine economic success with environmental protection and social responsibility. Through science and innovation, we enable our customers in nearly every industry to meet the current and future needs of society. Our products and solutions contribute to conserving resources, ensuring nutrition and improving quality of life. We have summed up this contribution in our corporate purpose: We create chemistry for a sustainable future. BASF had sales of over €74 billion in 2014 and around 113,000 employees as of the end of the year. Further information on BASF is available on the Internet at www.basf.com.

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