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Leucine - AI for Pharma

About

Leucine is an AI-powered platform that helps pharmaceutical manufacturers stay compliant and audit-ready while ensuring the right first-time batch release. Using Leucine, Manufacturing, QA, and QC teams can significantly increase productivity and reduce deviations from cGMP guidelines across thousands of complex regulated workflows from material receipt to batch release. Leucine supports manufacturers across all modalities such as small molecules, biologics, gene therapies, vaccines etc. We have built industry's first AI framework, Leucine10x, which is designed to serve as a co-pilot in pharmaceutical manufacturing processes. Built on proprietary LLM technology, Leucine 10X offers an army of AI co-pilots that perform highly specialized tasks such as digitizing paper-based SOPs, creating a digital twin of the shop floor, collaborating with Production Managers in creating dynamic production plans, thus ensuring on-time batch delivery. Most significant is its ability to speed up Root Cause Analysis (RCA) of deviations in the manufacturing process by quickly analyzing data, including text-based records, logs, and even staff interview transcripts, to identify potential issues or patterns that might not be readily apparent. Leucine is currently deployed at over 50 companies in over 300 pharmaceutical manufacturing facilities across 10 countries, including the US, India, Brazil, Mexico, UAE, and others. Our customers trust us to help them deliver safe medicine to patients worldwide. For more information, visit: https://www.leucine.io

Country

US

Address

New York

Company Type

Privately Held

Employees

111

Industry

Pharmaceutical Manufacturing

Specialties

21 CFR Part -11 ; EU GMP Annex-11; Data Integrity; FDA Validation; Artificial Intelligence; Machine Learning; GMP Compliance; Drug Product Quality; Quality Metrics; Manufacturing Execution System; Batch Planning; QC Planning; Investigations; Process Validation; Cleaning Validation; Product Changeover; Health-based Exposure Limits; Generative AI; Batch Execution; LLM; Batch Manufacturing Record

Top Decision Makers · 3

Director of Finance

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Heena Kosar

India

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Associate Product Manager

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Snehasis M.

India

Email

******@***.com

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(**) *** ****

Product & Strategy

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Rohan Kumar

India

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******@***.com

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(**) *** ****

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