Leucine - AI for Pharma
Pharmaceutical ManufacturingNew York, United States51-200 Employees
Leucine is an AI-powered platform designed for pharmaceutical manufacturing to support regulatory compliance and audit readiness, with the goal of reliable first-time batch release. It enables manufacturing, quality assurance, and quality control teams to boost productivity and reduce deviations from cGMP across thousands of regulated workflows from material receipt to batch release. The solution spans multiple modalities, including small molecules, biologics, gene therapies, and vaccines, and functions as a collaborative co-pilot on the shop floor by digitizing SOPs, creating a digital twin, and assisting with dynamic production planning and rapid root cause analysis of deviations. Based in New York, United States, Leucine operates as a mid-sized company with a broad global footprint, with its platform deployed at more than 50 pharmaceutical manufacturers across over 300 facilities in 10 countries. Its customers are manufacturers seeking to strengthen cGMP compliance and improve batch-delivery reliability across regulated processes from materials to release. In late 2025, Leucine announced a collaboration with Rx-360 to offer FDA Tracker Premium to consortium members.