We develop hard-to-make medicines, from molecule to finished dosage form.
Polpharma Group synthesises the active substance and develops the finished dosage forms around it, specialising in complex sterile, inhaled and combination products, up to an oligonucleotide pipeline in development for registration.
Developed products
260+
products in development
100+
specialized r&d centers
6
Full time employees
300+
doctorates
37
invested in R&D since 2000
€0.5B+
FDF R&D Centers
R&D network specialised by dosage form.
Solid oral dosage forms
Sterile & complex injectable
Inhalation & non-sterile forms
Generic medicines development
API R&D Centers
Active-ingredient development specialized by potency.
Small molecules & oligonucleotides
Highly-potent compounds & ADC
The development standard
A product leaves R&D only when it is stable, bioequivalent, reproducible, and patent-clear.
Preformulation, analytical & stability development
Preformulation, method development and validation, and a stability programme that proves shelf-life chemically and physically, with no polymorphic shift. Impurity work builds nitrosamine control into the method from the start.
Synthesis, formulation & process development
Formulation, then scale-up to a process validated at commercial scale. IP and regulatory strategy are set at route assessment, so the form is built around a clear patent position from the first feasibility study.
Bioequivalence
& clinical studies
We support product registration through robust study design, coordination and execution. Working with experienced partners worldwide, we ensure compliance with international regulatory standards throughout the process.
what it takes
We carry a molecule all the way to marketing authorisation.
The process is run for the Group's own pipeline and for development partners, from the first feasibility study to granted authorisation.
innovation & pipeline
Innovation, from a generic tablet to a synthetic-RNA oligonucleotide.
From platform to oligonucleotide pipeline
Preservative-free eye drops
Dry-powder inhalers
Single-pill combinations
Group’s commentary
Our innovation comes from a new route of administration, formulation, or combination of actives, a device co-developed with the medicine, or a synthesis route engineered around the patent - protected by 52 patents granted in the last five years, with 32 applications pending.
Behind the pipeline
300+ scientists, 37 of them doctorates, and a research base that extends well beyond our own labs.
Polpharma has put more than €0.5 billion into R&D since 2000 - work co-funded by competitive grants, run alongside national research institutes, and fed by a talent pipeline the company trains itself.
External funding
Ten development programmes carry external grant funding that refunds 40 to 60 percent of specific phase costs - over €40 million secured across the programme, with a further €6.5 million pending decision.
Scientific partnerships
Active research partnerships with the Łukasiewicz Network, the National Medicines Institute, Medical University of Gdańsk, Medical University of Lódź, and the Institute of Bioorganic Chemistry of the Polish Academy of Sciences anchor the work in the national research base.
Talent pipeline
Industrial PhD candidates run their doctoral research on live development programmes, co-supervised by the company and their university - the talent pipeline that fills the product pipeline.
External innovation & industry partnerships
We don’t build everything ourselves. We work with external partners where it makes sense – to access technologies, speed up development and stay focused on what we do best.
PARTNERSHIP models
Develop with the platform we built for our own pipeline.
Own Pipeline
API Co-development
FDF Co-development
API CDMO
Strategic R&D Partnership
"In the development of a second-generation drug, we seek innovative technologies. Our main objectives are improving product stability, having a positive impact on the environment, and improving patient comfort. This requires extensive research work and takes from three to ten years, involving top-class specialists from many scientific disciplines.
Katarzyna Malik Head of r&d
WHY US
From the chemistry of the active substance to the finished pharmaceutical product, on one integrated platform.
Development, scale-up and manufacturing of the active substance and finished form run in one group that also registers and sells the medicine. R&D is built against commercial-scale manufacturability and each market's regulatory requirements.
Patent-clear by design
The chemistry is engineered clear of third-party patents, and the dossier is prepared and filed during the patent term, so marketing authorisation is in place the day it expires.
Proven in the clinic
The complex injectables, including long-acting injectables, are carried through human studies that go past simple bioequivalence, which their generic approval demands.
Owned past launch
R&D keeps working on products after launch - improving processes on marketed lines, and re-engineering products to meet nitrosamine limits when the guidance changed.