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BASF offers the world's largest portfolio of chemical raw materials for the pharmaceutical industry, ensuring the needs of our partners are always met. Every step of biopharmaceutical manufacturing requires high-quality raw materials delivered through a transparent, sustainable supply chain. BASF Biopharma Ingredients is committed to meeting your requirements for every ingredient we supply to the biologics industry. At BASF, we create excipients that are safe, effective, and convenient for your customers. Whether you’re developing orally disintegrating formulations that require taste-masking or modified release tablets, BASF has ingredients to deliver the precision you need, every time. At BASF, we offer a comprehensive range of cutting-edge solubilization polymers, and have an unparalleled understanding of the corresponding process technologies. BASF offers an unparalleled portfolio of excipients for topical formulations, enabling you with the tools to overcome formulation challenges. With products based on over 150 years of industry experience, BASF is committed to maintaining the highest level of quality across the product spectrum. BASF offers a broad portfolio of chemistries designed to simplify the product development process. Coating polymers are suitable for a variety of oral formulation challenges. BASF's pharma grade lipid-based excipients are manufactured in GMP-compliant facilities with high quality and reliability in mind. Consisting of a broad portfolio of polyethylene glycols (PEGs), BASF's portfolio of ethoxylated polymer-solubilizers is known for its versatility across a myriad of dosage forms. BASF offers a broad portfolio of functional excipients including our pharmaceutical grade polysorbate and sorbitan esters. Povidones, copovidones, and crospovidones are versatile materials that serve as the foundation of oral solid dosage forms. BASF offers a broad portfolio of brand families that are suitable for oral, topical, parenteral, and biologic applications. Coprocessed excipients are combination, all-in-one solutions. Kollicoat® coating polymers are suitable for a variety of oral formulation challenges. Kollicream® pharma grade solvents and emollients are manufactured in GMP-compliant facilities with high quality and reliability in mind. Kollidon® povidones, copovidones, and crospovidones are versatile materials that are most commonly used for solid oral dosage forms. Kolliphor® solubilizers, emulsifiers, co-emulsifiers, and surfactants enable the development of safe and effective formulations. Kollisolv® solubilizers and solvents are suitable for a wide range of applications and processing methodologies. Kolliwax® structuring agents, moisture barriers, and lubricants enable the formulation of various dosage forms. Novata® hard fats are structuring agents and matrix builders. Soluplus® is a novel solubilizer, crystallization inhibitor, and a matrix forming polymer. Explore this collection of resources to learn more about our innovative research and pharma solutions.
  • U.S. Food and Drug Administration accepts Soluplus® branded excipient in its program to evaluate safety and acceptability of excipients for use in clinical trials, independent from a specific New Drug Application.
  • Excipients (inactive ingredients) such as the Soluplus® branded excipient play a critical role in enabling the drug development process for poorly soluble active pharmaceutical ingredients

Florham Park, New Jersey, December 5, 2022BASF Pharma Solutions announces today that the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Office of New Drugs, has accepted their excipient, Soluplus®, into the FDA’s Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME). The program seeks to reduce the risk and burden for pharmaceutical companies wishing to utilize novel excipients for modern drug development challenges as well as to provide a pathway for excipient manufacturers like BASF to obtain FDA review of their novel excipients prior to use in an FDA-approved drug.

The Soluplus® branded excipient has now moved into the next stage of the extensive evaluation process, and the FDA will share the results at the conclusion of this process.

“With our long history of developing novel excipients, it is especially rewarding that BASF is selected to participate in this pilot program,” states Jeff DeAlmeida, Senior Vice President, BASF Pharma Solutions. “We chose to submit this particular excipient for the FDA’s consideration as it can be used in the development of a wide range of vital medicines.”

The Soluplus® branded excipient (polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer) was specifically designed to improve the solubility and oral bioavailability of poorly soluble active pharmaceutical ingredients, which has been an ever-increasing challenge to the industry. “The review of novel excipients is a critical step in driving innovation in new materials to meet the global health challenges of today and the future,” states Dominik Odenbach, Director of Global Quality, Regulatory Compliance and External Affairs, BASF Pharma Solutions. Soluplus® is particularly suitable as a matrix polymer in hot melt extrusion, a key enabling technology utilized in numerous modern medicines.

“We would like to thank the FDA for introducing the novel excipient Pilot Program. IPEC-Americas, the IQ Pharma Consortium, and the USP all recognize the need for excipient innovation and the challenges for the adoption of novel excipients in drug development. The collaborative efforts among these groups have supported and advocated for this initiative. As the need for novel excipients has never been greater, we are optimistic that a successful pilot program will lead to a formal novel excipient review program in the near future,” says Nigel Langley, Global Technology Director at BASF and a Chair of IPEC-Americas.

BASF is a leader in innovation and has pioneered the development of novel excipients over several decades. More information about the FDA’s PRIME program can be found here: Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME) | FDA


About BASF

At BASF, we create chemistry for a sustainable future. We combine economic success with environmental protection and social responsibility. Around 111,000 employees in the BASF Group contribute to the success of our customers in nearly all sectors and almost every country in the world. Our portfolio comprises six segments: Chemicals, Materials, Industrial Solutions, Surface Technologies, Nutrition & Care and Agricultural Solutions. BASF generated sales of €78.6 billion in 2021. BASF shares are traded on the stock exchange in Frankfurt (BAS) and as American Depositary Receipts (BASFY) in the U.S. Further information at www.basf.com.

About BASF’s Nutrition & Health division

BASF Nutrition & Health provides a comprehensive product and service range for human and animal nutrition, pharmaceutical, and flavor & fragrance industries. With our science-driven portfolio, we address customers in globally growing markets to meet the demands of an expanding world population. Together with our customers, we play an active role in enhancing the nutrition, health and wellbeing of consumers all over the world. Our products fulfill the highest safety, regulatory and sustainability standards. BASF Nutrition & Health operates sites in Europe, North America and in Asia-Pacific. For more information, go to www.basf.com.

Deb Oliveri 

Pharma Solutions

  • +1 551-252-3567
  • deborah.oliveri@basf.com

Rebekka-Martina Müller

Media Relations Nutrition & Health

  • +49 151 65570069
  • rebekka-martina.mueller@partners.basf.com
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