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.

Cityscape of Milan with the illuminated Galleria Vittorio Emanuele II arch on the left and the Milan Cathedral on the right at dusk, with text promoting CPHI event in Milan from October 6-8, 2026, and a green button labeled '# 7A50'.

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.
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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

API R&D employees roking with a cryogenic equipment

We provide

professional support related to technology, analytical and special services.

R&D laboratory emplyees working on API manufacturing

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.

Employee overseeing commercial API manufacturing process

We support

and help you to overcome challenges during your formulation development through solutions tailored to your needs.

Delivering Experiences Through Meaningful Partnerships

Our zero-error mindset extends beyond the manufacturing process to ensure all projects go smoothly and stay on track.

Deep knowledge and technical support provided by Regulatory, analytical and chemistry in determining a strategy for potential genotoxic and elemental impurities as well as the experimental data needed to back it up. Finally, I have found Polpharma’s quality systems and people to be among the best that I have experienced.

CMC Consultant

The relationship we have with Polpharma represents a true partnership, Polpharma recognise that they are part of our Supply Chain and that they play a key role in ensuring that our patients are never without their product. This is demonstrated by Polpharma’s collaborative approach, their flexibility, their proactiveness in identifying opportunities, and their technical competence. The partnership that we have with Polpharma is a model that we aspire to developing with all our suppliers.

Senior Director Commercial Supply Chain

One of the most important benefits I see in working with Polpharma is the relationship of teamwork and transparency. It is remarkable that after almost 5 years on this project, the key team members including project leader, analytical chemistry, process chemistry, Regulatory and Quality, have remained essentially the same. I have never seen this with another CMO and the continuity that it provides has been invaluable.

CMC Expert
Cityscape of Milan with the illuminated Galleria Vittorio Emanuele II arch on the left and the Milan Cathedral on the right at dusk, with text promoting CPHI event in Milan from October 6-8, 2026, and a green button labeled '# 7A50'.

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.

Pharmaceutical Quality System per cGMP / EU GMP Part II (ICH Q7); QRM per ICH Q9; TrackWise QMS; validated data-integrity controls; batch records retained ≥8 years.
Inspected by FDA (2004, 2009, 2012, 2015, 2018), and by EMA/PIC-S authorities, PMDA (Japan), ANVISA (Brazil), and KFDA (Korea); GMP certificates listed in EudraGMP.
EU–US mutual recognition: for ANDA filings, the Polish authority's GMP report is accepted by FDA (no separate facility inspection required).
Client quality audits accommodated annually (and for-cause).ISO 14001 (environmental) and ISO 45001 (occupational H&S) certified; EcoVadis Silver, 74/100.

A Track Record of Compliance

Over 30 successful audits by global regulators and partners confirm our consistent
commitment to the highest standards.

US FDA

2018

Polish MPI

2019

Polish MPI

2020

Polish MPI

2021

ANVISA Inspection

2022

Polish MPI

2023

Expert Take on Industry Standards

Dawid Ignatowicz, Head of CDMO Global

“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."

Dawid Ignatowicz

Head of CDMO API
Cityscape of Milan with the illuminated Galleria Vittorio Emanuele II arch on the left and the Milan Cathedral on the right at dusk, with text promoting CPHI event in Milan from October 6-8, 2026, and a green button labeled '# 7A50'.

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

30
Process development specialists
40
Analytical development specialists
20
Regulatory & tech support specialists

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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API pilot plant equipment
API pilot plant equipment
API pilot plant equipment
API pilot plant equipment
API pilot plant equipment
API packing room
API micronizer

Micronizer (Jet Mill) 5 cm diameter.

Discharge of nutsche-filter

Discharge of nutshe-filter.

API pilot plant clean zone

Clean zone with vertical axe SS centrifuge and movable closed pressure nutshe-filter.

Crystalizers

Crystalizers:

100 dm3 GL, 250 dm3 GL and 500 dm3 GL.

Dissolutors

Dissolutors:

500 dm3 SS, 250 dm3 GL and 100 dm3 GL

Cityscape of Milan with the illuminated Galleria Vittorio Emanuele II arch on the left and the Milan Cathedral on the right at dusk, with text promoting CPHI event in Milan from October 6-8, 2026, and a green button labeled '# 7A50'.

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.

Dawid Ignatowicz

Dawid Ignatowicz

Head of CDMO API
Rafał Rostankowski

Rafał Rostankowski

Head of R&D API
Paweł Olszowy

Paweł Olszowy

Head of Analytical Development

Peter Mondolfi

CDMO BD US
Claudio Salvagnini

Claudio Salvagnini

CDMO BD Europe & Japan
Monika Kuźma

Monika Kuźma

KAM CDMO
Jolanta Pawłowska

Jolanta Pawłowska

Technical Advisor CDMO

Start Your Product Journey Today

Let’s connect and collaborate on your next project! Our specialists will be happy to guide you through the entire cooperation process from development to commercial launch.

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