Highly Potent APIs (HPAPIs) CDMO Services
Product Description
ESTEVE CDMO
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Country/Region:Spain
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On CPHI since:2015
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Certificates:5
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Employees:1000 - 4999
Company types
Primary activities
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Categories
Specifications
ESTEVE CDMO
-
Country/Region:Spain
-
On CPHI since:2015
-
Certificates:5
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Employees:1000 - 4999
Company types
Primary activities
More Products from ESTEVE CDMO (3)
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Product Small-molecule API Research & Development
ESTEVE CDMO provides integrated, phase-appropriate API and HPAPI development services for complex small molecules, from early route design and reaction screening to process optimization, scale-up and pre-validation.
Our global R&D teams combine process chemistry, analytical development, proc... -
Product Small-molecule API Manufacturing
From clinical manufacturing to reliable commercial supply
ESTEVE CDMO provides flexible, reliable and fully integrated API and HPAPI manufacturing services, supporting complex small-molecule programs from clinical supply through validation and commercial production.
Across our... -
Product Spray Drying Development and Manufacturing Services
ESTEVE CDMO provides integrated API spray drying development and manufacturing services for complex small-molecule programmes, from early feasibility and process development through scale-up, cGMP spray drying, clinical supply and commercial manufacturing.
With more than 15 years of spray drying...
ESTEVE CDMO resources (10)
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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. -
Video ESTEVE CDMO Spray Drying Services
Choosing a Spray Drying Manufacturer: Why Flexibility and Customizability Matter.The spray drying of active pharmaceutical ingredients (APIs) is a technology... -
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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Brochure Spray Drying Services
Spray Drying - Adding value to your API. Esteve Quimica constantly strives to offer the best-in-class service to its customers. Understanding customer spec... -
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.
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Whitepaper Delivering GMP Certainty for Orphan Drug API Programs
A biotech company developing an orphan drug therapy partnered with ESTEVE CDMO to transform an inefficient, non-GMP synthesis into a robust, CGMP-ready process.
The original route showed clear limitations: poor scalability, inconsistent yields, and an amorphous API unsuitable for clinical and registration manufacturing.
The goal was clear: redesign the process to achieve a scalable, crystalline API capable of reliable multi-kilogram CGMP production and future commercial validation. -
Whitepaper Building a Resilient API Strategy
This case highlights ESTEVE CDMO’s strengths as a late-stage and commercial partner:
A global oncology biopharma company sought to de-risk its API supply by securing a secondary manufacturer outside China for a high-volume oncology therapy.ESTEVE CDMO was selected for its Global network, advanced capabilities in high-pressure hydrogenation and jet milling, and proven regulatory track record. By implementing a dual-site manufacturing strategy with synchronized tech transfer, safety validation, and analytical readiness, ESTEVE CDMO met an aggressive 18-month PPQ timeline. -
Whitepaper Fixing the Unscalable - Case Study
This case study highlights the importance of choosing a CDMO with the expertise and strategic capabilities to turn flawed processes into robust, scalable CGMP routes, delivering quality and speed under pressure.
ESTEVE CDMO specializes in refining processes that are not scalable or CGMP-compliant into reliable, robust manufacturing routes. -
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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Brochure Choosing a Spray Drying Manufacturer: Why Flexibility and Customizability Matter
The spray drying of active pharmaceutical ingredients (APIs) is a technology widely used to enhance bioavailability for poorly soluble materials, dry heat-se...