Amruta Mhashilkar

Director, Formulation and Process Development at Catalent

Speaker

Amruta Mhashilkar is Director of Formulation and Process Development at Catalent, where she leads a team of 35+ scientists and technical professionals and oversees a portfolio of 80+ programs spanning preclinical through commercial stages. She specializes in lipid-based drug delivery systems, including softgels and complex oral formulations, with a focus on enabling bioavailability and scalable, phase-appropriate manufacturing solutions. Amruta has supported over 100 client programs across leading pharmaceutical and biotechnology companies and has contributed to multiple successful Rx product launches. Her expertise spans CMC strategy, formulation development, scale-up, and regulatory support across IND, NDA, ANDA, and ANADA pathways. She is known for combining deep technical expertise with strong execution and cross-functional leadership to accelerate development timelines and translate complex molecules into commercially viable therapies.