Highly Potent APIs (HPAPIs) CDMO Services

Product Description

ESTEVE CDMO supports high-potency small-molecule programs from process and analytical development through cGMP manufacturing and commercial supply.

Our dedicated Highly Potent API capabilities include a specialized R&D laboratory in Barcelona and an industrial manufacturing sites, designed to handle compounds with OELs down to 30 ng/m³.

Integrated containment systems support reactor charging and sampling, filtration and drying, milling and sieving, dispensing, packaging and quality control testing.

Our process development, analytical, EHS, engineering, quality and manufacturing teams work together to assess containment and scale-up requirements early, define a clear path to plant and develop robust, scalable processes with visible technical control at every stage.

ESTEVE CDMO

  • Country/Region:
    Spain
  • On CPHI since:
    2015
  • Certificates:
    4
  • Employees:
    1000 - 4999
Company types
CMO/CDMO
Contract Service
Manufacturer/Innovator
Primary activities
API Producer
Chemical Development
Contract Manufacturer
Custom Manufacturing/Custom Synthesis
Intermediates Manufacturer
Specifications
  • Selling Points
    Quality Service; Sustainability;
    • Development-to-manufacturing continuity 
    • Containment capabilities down to 30 ng/m³ 
    • Controlled handling across critical unit operations 
    • Integrated process, analytical, EHS and quality expertise 
    • Industrial development designed for scale-up 
    • Visible technical control and direct expert access
  • Supplied from
    China; Mexico; Spain; United States

ESTEVE CDMO

  • Country/Region:
    Spain
  • On CPHI since:
    2015
  • Certificates:
    4
  • Employees:
    1000 - 4999
Company types
CMO/CDMO
Contract Service
Manufacturer/Innovator
Primary activities
API Producer
Chemical Development
Contract Manufacturer
Custom Manufacturing/Custom Synthesis
Intermediates Manufacturer

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ESTEVE CDMO resources (9)

  • News ESTEVE CDMO acquires Regis Technologies, expanding U.S. presence and capabilities

    This strategic move allows ESTEVE CDMO (actively operating under the Esteve Química brand) a physical presence in the United States, expanding its contract development and manufacturing solutions for innovative small-molecule active pharmaceutical ingredients (APIs) across the entire drug development lifecycle from pre-clinical to commercial manufacturing.
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  • News Esteve Named Global Champion in Small-Molecule API Category at the 2025 CDMO Leadership Awards

    Esteve was honoured with the 2025 CDMO Leadership Award in the Small Molecule API – Global category and also recognized with the Champion Award, delivered to the CDMO with the highest ranking in this category.
    These prestigious recognitions reflect not only our commitment to excellence in pharmaceutical development and manufacturing but also the trust and collaboration of our clients and partners worldwide. We would like to extend our deepest gratitude to everyone who has made this journey possible. ​And above all, a heartfelt thank you to our incredible team at who has provided the opportunity of receiving such remarkable achievements ESTEVE. You are the driving force behind our success.​​

    This award is the result of a shared effort, a collective commitment to delivering value, innovation, and better health for people everywhere. Let's keep advancing health together!​
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  • News Esteve invests €100 million in new manufacturing plant in Spain

    Spain-headquartered CMO Esteve expands its manufacutring capacity in plants in Girona, Spain to increase global API offerings with advanced technological solutions, through a weighty investment of €100 million. 

  • Whitepaper Lightspeed Global API Delivery - Case Study

    ESTEVE CDMO industrialized and delivered 20 metric tons of API in nine months, with manufacturing starting just 70 days after project award. Success was driven by coordinated multi-site execution, a harmonized quality system, a global supply chain and close collaboration with the customer.

    Read the full case study to discover how the program was delivered at speed and scale.

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