Polpharma API CDMO
Polpharma API is a leading European CDMO that develops and manufactures high-potency/oncology APIs
with containment to OEL 10 ng/m³ (OEB 6);
payload–linkers for ADC and oligonucleotides from early clinical development through to commercial GMP supply, for pharma and biotech worldwide.
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A New Standard in CDMO Excellence for Small Molecule Development
Built on more than 20 years as a service provider and 75 years of API manufacturing expertise.
We develop and manufacture high-potency/oncology APIs with containment to OEL 10 ng/m³ (OEB 6), payload–linkers for ADC and oligonucleotides, from early clinical development through to commercial GMP supply, for pharma and biotech worldwide.
We deliver broad synthetic chemistry; particle engineering and polymorph control; full analytical development and stability from our FDA-approved, EU-GMP-certified European site.
What We Promise, We Deliver

We provide
professional support related to technology, analytical and special services.

We collaborate
closely with you in order to search for and suggest solutions on a day-to-day basis working in parallel with your technicians and analysts to offer the best solutions along the way.

We support
and help you to overcome challenges during your formulation development through solutions tailored to your needs.
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Quality & Regulatory track record
Our cutting-edge facilities for R&D, pilot production, manufacturing, and quality control, combined with the extensive expertise in developing and manufacturing highly complex APIs, enable us to offer a diverse range of services across the entire value chain. Supported by an engaged, highly skilled, and accountable team of nearly 500 experts, we partner with clients throughout the entire product life cycle, from early-stage clinical candidates to commercial launches, ensuring seamless collaboration and consistent results at every stage.
Expert Take on Industry Standards
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“Inexperienced or overstretched CDMOs can run into delays, deviations, and compliance issues that can jeopardize a project or regulatory submission. At Polpharma, we follow a zero-error approach, as demonstrated by over 30 successful audits and EU GMP certifications across all departments, which ensures processes are consistent and fully compliant. We help our clients stay aligned and keep projects on track from early trials to commercial launch through rigorous quality standards and transparent communication."
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Specialized Capabilities
Equipment Type
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- GL/SST/HST
- Columns
- Crystallizers
- Centrifuges
- Lyophilizer
- Dryers
- Filter-dryers
- Mills
- Micronizers
- Hydrogenation
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On-Site Expertise
Process Chemistry Capabilities
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- Amidation
- Acetylation
- Bromination
- Chlorination
- Chlorosulphonation
- Cyclization
- Coupling
- Carboxylation
- Dehydrogenation
- Lithiation (with BuLi)
- Chlorosulphonation
- Esterefication
- Friedl-Craft’s alcylation
- Grignard’s reaction
- Hydrogenation
- MethylationMetho-
/Ethoxylation - Oxidation/Reduction
- Phosegenation (with triphosgene)
- Saponification
- Strong base reaction
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Partnership You Can Rely On
A trusted CDMO partner for 20 years, delivering transparency,
flexibility, and reliable execution across the product lifecycle.
Talk to Our Team
Make your vision a reality! Connect with our enthusiastic and dedicated team and have trusted partners on your side.




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