Strategies & Solutions for Launching OTC & Rx Gummies

In this session, Aaron Dely, Vice President of R&D at PLD Pharma Services, explores the opportunities and challenges of developing over-the-counter (OTC) and Rx gummies. Dely explains why consumer demand for gummies – driven by improved compliance – is fuelling rapid growth and premium pricing in this dosage form. He highlights key technical and regulatory hurdles, from API suitability and heat stability to taste masking, texture, and FDA expectations. Drawing on real-world examples, Dely showcases how PLD leverages decades of formulation and manufacturing expertise, a dedicated R&D lab, and its state-of-the-art gummy facility in New York. The presentation details PLD’s proprietary solutions, including a custom 4-way blending process for exceptional product uniformity, precise pH and viscosity controls, and deposit accuracy in the single digits far exceed typical confectionery standards. Attendees will gain practical insights into overcoming formulation challenges and responsibly commercialising safe, high-quality gummies.