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Leucine

No-code platform automating compliant drug manufacturing

Overview

Leucine.io provides a no-code orchestration platform for drug manufacturing that helps QA, manufacturing, and QC teams convert paper procedures into digitally signed, self-executing work instructions. Its Process Builder digitizes workflows, captures data, and enforces verifiable steps with built-in cGMP-compliant protocols. The system logs all quality events and offers dynamic batch scheduling suggestions to improve efficiency and compliance, with a subscription model targeting Fortune 500 pharmaceutical companies. The platform differentiates itself by offering ready-made compliance workflows, centralized logging, and scalable customization in a no-code interface tailored for large manufacturers.

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About Leucine

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Industries

Data & AnalyticsEnterprise SoftwareHealthcare

Company Size

51-200

Company Stage

Series A

Total Funding

$8M

Headquarters

Bengaluru, India

Founded

2015

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Simplify's take

What believers are saying

  • Amneal's Brookhaven packaging records went live on May 6, 2026.
  • OneSource Specialty Pharma went live with MES on April 29, 2026.
  • Piramal Pharma deployed CLEEN at Turbhe on March 11, 2026.

What critics are saying

  • Heavy reliance on pharma buyers leaves revenue exposed if validation cycles stall.
  • SAP, LIMS, and legacy MES vendors can bundle compliance modules faster.
  • If FDA rejects agentic AI records, one inspection failure could cripple sales.

What makes Leucine unique

  • LeucineOS unifies MES, QMS, CLEEN, and FDA Tracker on one ontology.
  • Its 2026 agentic layer automates deviation detection, batch review, and predictive CAPA.
  • Production runs at 400+ GMP facilities, including Cipla, Amneal, Piramal, and OneSource.

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Funding

Total Funding

$8M

Below

Industry Average

Funded Over

2 Rounds

Series A funding typically happens when a startup has a product and some customers, and now needs funding to scale. This money is usually used to grow the team, expand marketing, and improve the product. Venture capital firms are frequently the main investors here.
Series A Funding Comparison
Below Average

Industry standards

$15M
$7M
$8.2M
$15M
$30M

Benefits

  • Health Insurance
  • Meal Benefits
  • Parental Leave

Growth & Insights and Company News

6 month growth

0%

1 year growth

2%

2 year growth

0%
TechCrunch
Oct 16th, 2023
Leucine Makes Drug Manufacturing Compliance Less Onerous

The compliance process at pharmaceutical manufacturers is a complicated and prone to errors because many still use paper-based systems to record manufacturing steps. These paper records are reviewed by FDA auditors to ensure that guidelines were followed, but they are prone to errors, often leading to warnings. This results in higher costs and slower manufacturing. Leucine wants to make the compliance process more efficient with its compliance cloud platform for the pharmaceutical industry. It automatically creates digital manufacturing records and uses AI to identify the root cause of deviations.New York-based Leucine announced today it has raised a $7 million Series A led by strategic investor Ecolab Inc. Participants include returning investors like Pravega Ventures, Axilor Ventures, Techstars and angel investors

Cryptopolitan
Oct 16th, 2023
Leucine's Digital Solution Set to Revolutionize Pharmaceutical Manufacturing Compliance

New York-based start-up, Leucine, after securing a $7 million Series A funding led by Ecolab Inc., has unveiled its compliance cloud platform specifically tailored for the pharma sector.

Mealo Sports Supplements
Dec 24th, 2021
LeucineTech launches A Sports supplement in READY TO DRINK formulation “Gold series BCX Advanced” BCAA

For the First Time in India MealO has introduced A Sports supplement in READY TO DRINK formulation “Gold series BCX Advanced” BCAA is a tested and trusted workout supplement that features the branched chain amino acids Leucine, Isoleucine, and Valine, which work together to support improved performance, lean muscle building, and accelerated muscle recovery.

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