As pharmaceutical and consumer healthcare companies look to expand into the US market, manufacturing strategy has become just as important as product innovation. Regulatory complexity, evolving quality expectations and the need for reliable supply chains are driving more global brand owners to seek experienced US-based manufacturing partners that understand how to navigate one of the world's most demanding healthcare markets.
At CPHI Milan, contract development and manufacturing organisation Formulated Solutions will showcase how companies can commercialise products for the US market through an integrated approach to formulation development, manufacturing and regulatory support.
For more than 25 years, the company has worked with pharmaceutical, consumer health and personal care companies to take concepts through to commercial products manufactured in the United States. Its offering extends beyond contract manufacturing, with the company partnering with customers throughout development, scale-up, validation and commercial production to reduce technical risk and accelerate market readiness.
The company's capabilities span a broad range of topical dosage forms and delivery systems, including creams, lotions, gels, ointments, solutions, suspensions, foams and aerosol products. It also specialises in advanced container closure technologies, including Bag-on-Valve (BoV) systems, which can improve product stability, dosing consistency and patient experience for sensitive formulations.
Formulated Solutions manufactures across multiple regulatory classifications, operating FDA-registered facilities supporting prescription pharmaceuticals, over-the-counter (OTC) drug products, cosmetics, consumer healthcare products and combination products. Its quality systems are designed to meet current Good Manufacturing Practice (cGMP) requirements while providing customers with the documentation and regulatory support needed for commercialisation in the United States.
For European companies, entering the US market often presents distinct challenges. Product classifications can differ significantly from those in the European Union, requiring careful evaluation of regulatory pathways, labelling requirements, manufacturing controls and quality expectations. Working with an experienced US partner early in development can help avoid costly delays while ensuring products are designed for regulatory success from the outset.
Beyond regulatory expertise, supply chain resilience has become a strategic advantage. Manufacturing in the United States gives companies greater flexibility, shorter lead times for North American distribution and a dependable production footprint that supports long-term commercial growth.
Innovation also remains a key differentiator. Formulated Solutions combines formulation science, analytical development, process engineering and packaging expertise to develop products intended not only to meet regulatory requirements but also to deliver improved consumer and patient experiences – whether optimising a topical foam for better adherence, selecting an aerosol delivery system or engineering a differentiated container closure solution.
CPHI Milan offers European and global innovators an opportunity to learn how US-based manufacturing can accelerate market access while strengthening product performance and supply chain confidence. Organisations planning to launch or expand into the United States can visit the Formulated Solutions team at the show to discuss its integrated development and manufacturing capabilities.
For more information
Visit: www.formulatedsolutions.com
Why global brands are choosing US manufacturing: Formulated Solutions to exhibit at CPHI Milan
