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Cutting-edge technology and hard-to-make molecules, standard plants can't run.

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High-potent oncology, oligonucleotides and cryogenic synthesis at FDA-approved European sites - and a flexible partnership approach, open to long-term work across products, customers and geographies.

APIS in Portfolio

70+

APIs in commercial supply

40+

FDA inspections passed

5

Patents granted aCROSS Portfolio

65

Audits hosted per year

35+

Certificates across all departments

EU GMP

Technology platforms you don't have to build.

The synthesis technology behind an API decides which therapeutic categories a generics business can enter. We develop each molecule in our own laboratories and run it at commercial scale, with the analytical and regulatory teams that file it.

Cryogenic

Low-temperature reaction systems down to -90 C across pilot, kilo-lab and commercial scale. Lithiation, metallation and superbase chemistry running on the same floor as commercial production, in Hastelloy and glass-lined reactors up to 6,300 L.
TO -90 C · UP TO 6,300 L

Hazardous Chemistry

High-energy reactions built deliberately into the route, from Grignard and lithiation to phosgenation and Friedel-Crafts. Step counts drop, impurity profiles clean up, and molecules that would otherwise need a long way around become viable at commercial scale.
GRIGNARD · LITHIATION · PHOSGENATION · BISPHOSPHONATION

High-Potent API

Containment for cytotoxic, hormonal and other high-activity compounds at OEB 5/6, with exposure limits down to 10 ng/m3. The platform that opens oncology - seven targeted oncology actives are already in development on it - and the modalities whose handling sits beyond a standard generics plant.
OEB 5/6 · TO 10 NG/M3 · GMP + FDA

Oligonucleotides

Solid-phase synthesis with sterile downstream and lyophilisation, at clinical and early-commercial scale up to 50 g per batch under GMP. The platform behind our oligonucleotide pipeline, with nusinersen in development for registration and the antisense chemistry that carries it.
STERILE DOWNSTREAM · LYOPHILISATION · 50 G GMP

Payloads & Linkers

Cytotoxic payload synthesis and linker chemistry on the same OEB 5/6 containment as our high-potent platform. The route into antibody-drug conjugates, where the small-molecule warhead and its linker are made under the potency limits an ADC demands.
ADC CHEMISTRY · OEB 5/6

Solid State Chemistry

Polymorph engineering and crystal-form selection across the portfolio - every API in our catalogue is filed with its solid form characterised. The form a molecule takes decides whether we design around the originator's patent and launch at expiry, and hold the line against the next generic entrant.
POLYMORPH ENGINEERING · IP DESIGN-AROUND

Group’s commentary

With reactor volume from 150 L to 6 000 L in 6 interconnected buildings, operating from -50°C to +200°C pressure up to 10 bar, and highly automated units for reaction parameters monitoring and control, we are being positioned among top European API CDMOs.

API manufacturing network

Active ingredients made in Europe. Held to one quality system.

Starogard Gdański
,
Poland
ZF Polpharma

Full-scale synthesis and high-potent

The Group's FDA-approved, cGMP API plant. A pilot plant, six interconnected production buildings, the dedicated High-Potent facility, and the wet-chemistry and instrumental QC labs that release every batch. Process, analytical and regulatory work all run on one campus - a molecule is developed, scaled and supplied without ever leaving it.
Warsaw
,
Poland
ZF Polpharma

Registered production and intermediates

Where proven chemistry is produced at volume. Registered API production for eleven substances and six intermediates from the developed portfolio - EU GMP, audit-current, on the same dossiers and quality system as Starogard. It holds commercial capacity on established products, freeing Starogard for the platform-intensive development work.

70+ APIs across the therapeutic spectrum.

The portfolio runs deepest in cardiology, neurology, musculoskeletal and oncology, with anticoagulation, and an emerging oligonucleotide platform. Of 70+ active substances, around 40 are in commercial supply with filed dossiers.

See our full GMP-compliant API Portfolio
Oncology & advanced therapies
Oligonucleotides
Nusinersen sodium is in development, the Group's first oligonucleotide active, via solid-phase synthesis with sterile downstream processing and lyophilisation.
RX
Oncology & advanced therapies
Oncology
All oncology actives are in development as high-potency (HPAPI, OEB 5/6) substances: palbociclib, abemaciclib, talazoparib, enzalutamide, vismodegib, trametinib and inavolisib.
RX
Women's & men's health
Urology
The PDE5 actives sildenafil, tadalafil and vardenafil are commercial on CEP and multiple DMFs, alongside tolterodine for overactive bladder.
RX
/
CHC
Women's & men's health
Gynecology
Elagolix sodium is in development for endometriosis, with US and EU DMFs pending.
RX
/
CHC
Immunology & inflammation
Immunology
The JAK1/JAK2 inhibitor baricitinib, on US and EU DMFs, and the S1P modulator etrasimod are in development for inflammatory and autoimmune disease.
RX
Immunology & inflammation
Musculoskeletal
The bisphosphonates alendronate, ibandronate, risedronate and zoledronic acid are commercial on CEP with injectable grade, alongside baclofen and etodolac, with apremilast in development.
RX
/
CHC
Respiratory, ophthalmic & ENT
Allergology
The antihistamines antazoline (hydrochloride, mesylate and sulfate) and clemastine fumarate are in commercial supply on EU DMF.
RX
/
CHC
Respiratory, ophthalmic & ENT
Otorhinolaryngology
Xylometazoline hydrochloride, a nasal decongestant, is in commercial supply on CEP and EU DMF.
RX
/
CHC

PARTNERSHIP models

Start at any point between first route and routine supply.

API Co-development
API Supply
API CDMO

API Co-development

Joint ownership of a new substance neither side has carried alone: the Group brings chemistry, regulatory infrastructure and commercial-scale manufacturing, you bring target, clinical strategy and market access. Cost, IP and split agreed up front.
Shared cost. Shared upside.

API Supply

Direct supply of a substance already developed, registered and in routine production. The DMF is already filed in every market where you plan to launch, so there's no development cycle on your side. Batches release-tested to both Ph. Eur. and USP, so one lot covers either market. Capacity reserved on long-term supply terms.
Our portfolio. Your launch.

API CDMO

A molecule with no route yet, developed from feasibility through to commercial supply, with the high-potent, oligonucleotide and cryogenic platforms available from the first step. Route assessment to CEP, EU and US DMF filing on one site, and contract manufacturing of an established substance runs as the commercial stage of the same model.
Your molecule. Our chemistry.

"After 15 years at Polpharma every day reassures me that the greatest assets we have are our committed, skilled scientists and the strong relationships we have built with our customers and business partners."

david ignatowicz Head of cDmo api

Scale continuity

A molecule moves from Phase 1 clinical batch to multi-tonne campaign without leaving the site.

Method re-validation, qualification batches and per-market audit cycles are handled as part of the operating routine.

1
Phases 1–2 · Development

Process development & tech transfer

Route assessment, lab-scale process development and phase-appropriate method validation. The route is built once and carried through scale-up on site.

Phases 1–2 · Development

Lab → kg scale

2
Phase 3 · cGMP batches

Process validation
& impurity control

Solid-state work and particle-size control via milling and crystallisation. Impurity characterisation covers nitrosamines, genotoxins and unknowns.

Phase 3 · cGMP batches

KG → PILOT SCALE

3
Registration

Regulatory submission
& approval

eCTD filed per launch market by the regulatory function that built the dossier. Quality and data systems: TrackWise, LIMS, EDMS and DCS.

Registration

Validation batches

4
Commercial

Commercial supply

Routine commercial supply continues the process developed in R&D. Batches run on the same plant and quality system that carried the launch.

Commercial

MULTI-TONNE

Previous
Next

Regulatory track record

An audit record built across two decades 
of FDA, EMA, and global regulator scrutiny.

FDA inspections in 2004, 2009, 2012, 2015 and 2018; ANVISA in 2022; Polish MPI every year, alongside customer quality teams and partner audits.

Track record at a glance

regulatory in numbers

5

FDA inspections

passed

35

Audits

hosted per year on site

65

Patents

‍granted across the technology portfolio

EU GMP

Certificates

across all departments and all API products

We manufacture our products in strict accordance with the highest standards set by our customers and health authorities.

Regulatory

Our DMF documentation for all products is prepared to comply with the latest regulations: EDQM (CEP), ICH (EU DMF, CTD), and FDA (US DMF). Furthermore, all material and product testing is conducted in alignment with the European and United States Pharmacopeias, ensuring the utmost quality and compliance.

Health Canada
·
Canada
NMPA
·
China
MFDS
·
South Korea
PMDA
·
Japan
ANVISA · CADIFA
·
Brazil
EAEU GMP
·
EAEU
US FDA
·
United States
URPL
·
Poland
GIF
·
Poland
EDQM · CEP
·
EU
EMA
·
EU

The team that operates the chemistry

Zero-Error Thinking. 
Powered by People.

500 experts work to one standard across chemistry, registration and quality. Partners deal directly with the people on their molecule, with full visibility from feasibility through multi-tonne supply.

Direct access to the experts

You work with the chemists, analysts and regulatory leads on your molecule. The team running the chemistry is the team you talk to.

The same team, years in

Project leads, chemists and quality contacts stay on a molecule for years. Partners have kept the same core team through a five-year engagement.

One shared workspace

A transparent project framework: a shared workspace for tracking, weekly updates, and full access to raw data.

Scale-up stays on site

R&D, pilot plant, production and QC share the Starogard campus. A process moves from bench to commercial reactors without changing sites.

“In the area of ​​business development, we focus on CDMO partnerships with emerging biopharmaceutical companies, which account for as much as 60% of oncology research conducted in 2023”

Shlomo Gang General Manager, POLPHARMA API

WHY US

We partner across the spectrum: 
From clinical-stage biotech to established generic manufacturers.

Emerging biotechs bringing a single molecule, and large pharma moving volume, we work across the full lifecycle, from first clinical candidate to commercial launch.

Biotech, clinical stage

A single molecule with no process yet. We develop the chemistry and carry it from gram-scale to first GMP batches.


Generic manufacturers

Established players sourcing registered API, or a second qualified supplier on an existing process.


Strategic & research partners

Joint development of new substances, and scientific collaboration - including academic work behind the rare-disease pipeline.