# Leucine - AI for Pharma

> Leucine provides enterprise software for pharmaceutical manufacturing, quality operations and laboratories. Its products connect electronic batch records, logbooks, cleaning validation, investigations and regulatory intelligence, with AI assistance and controlled approval workflows.

- **Founded:** 2019
- **Headquarters:** New York, United States
- **Founders:** Vivek Gera (Co-founder and CEO), Mustaq Singh Bijral (Co-founder and Chief Product Officer)
- **Products:** Leucine MES, LeucineOS / AI-QMS, CLEEN, FDA Tracker, Leucine 10X
- **Notable:** Company reports 400+ GMP facilities on its current website., Valent BioSciences study reports batch review falling from 20 days to one., Cipla study reports 30 sites and 84 million data entries.

## Products & services

- **Leucine MES** — Manufacturing execution, electronic batch records, scheduling, dispensing, electronic logbooks and batch analytics.
- **LeucineOS / AI-QMS** — Connected quality applications for documents, training, deviations, CAPA, changes, complaints, suppliers and laboratory workflows.
- **CLEEN** — Cleaning validation with health-based exposure-limit calculations, protocol generation and traceable reporting.
- **FDA Tracker** — FDA inspection, Form 483 and warning-letter intelligence; offers free and paid access tiers.
- **Leucine 10X** — AI framework introduced in beta in October 2023 for specialised pharmaceutical manufacturing tasks.

## Achievements

- Company reports 400+ GMP facilities on its current website.
- Valent BioSciences study reports batch review falling from 20 days to one.
- Cipla study reports 30 sites and 84 million data entries.
- Piramal study reports digitisation at 10+ facilities.
- Current About page claims $10M+ raised in total; dates and composition beyond the verified Series A are unspecified.

## Latest updates

- **2025-11** — Rx-360 announced complimentary FDA Tracker Premium for consortium members.
- **2026-02** — CPO Mustaq Singh published an AI roadmap describing a unified data architecture and agentic platform.
- **2026-08** — Company LinkedIn posts describe participation in the PDA India Global Vaccine Ecosystems Forum and demonstrate manufacturing, cleaning and investigation tools.

## Links

- Website: https://www.leucine.io/
- LinkedIn: https://www.linkedin.com/company/leucine/
- Twitter/X: https://twitter.com/LeucineHQ
- YouTube: https://www.youtube.com/@Leucine10X

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Profile page: https://yespress.io/leucine-ai-for-pharma
Published by YesPress — https://yespress.io
Last updated: 2026-10-03