About Us

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.

Polpharma API

API R&D laboratory team working together

Our flexible cooperation models enable us to meet the specific needs of our partners. By collaborating closely with others in the pharmaceutical sector, we achieve shared successes and provide innovative, effective therapies for patients. Together, we are dedicated to advancing healthcare through strong partnerships.

Best fit

CDMO partners: pharma and biotech developing their own molecules — including high-potency, oncology and other complex programs — seeking a hands-on European partner from clinical scale to commercial supply.
Generics buyers: generic-drug manufacturers and procurement teams sourcing dossier-ready APIs with reliable European supply.
Contract Manufacturing (CMO): We offer manufacturing services to other companies, which can be beneficial if they need manufacturing support but still want to focus on other aspects of their business. For FDF CMO services of Polpharma Group, visit Polpharma CMO.

Why partnering with Polpharma API?

Capabilities

Broad type of technologies with end-to-end solutions from process development to large-scale production

Global reach

FDA-approved plant located in Central Europe with presence on +70 markets around the world

Fast execution

Fully integrated Business Unit, from R&D, IO, Supply Chain to Commercial with fast-decision making

Key numbers

+75

years of experience

years of trusted partnerships

markets

patents

500

employees

+70

products

continents

audits per year

Quality, Regulatory & Sustainability

Pharmaceutical Quality System per cGMP / EU GMP Part II (ICH Q7); TrackWise QMS; QRM (ICH Q9)

Inspected by FDA, EMA/PIC-S authorities, PMDA, ANVISA and KFDA; GMP certificates in EudraGMP

ISO 14001, ISO 45001, ISO/IEC 17025-aligned labs; EcoVadis Silver (74/100); Diversity Policy; Sustainable Development Strategy

World map with API certification authorities.

API Manufacturing Sites

Aerial view of a large industrial complex with multiple modern buildings, surrounded by trees and roads on a clear day.

We are the largest Polish manufacturer of active pharmaceutical ingredients.

Scale & capacity
‍~370 m³ of installed capacity across 227 reactors (5 L–6,300 L; glass-lined, stainless steel, Hastelloy).
Batch scales from grams (kilo lab) to 800 kg (commercial); ~60–70% utilization (available capacity).

‍Technical strengths
‍High-potency/oncology APIs with containment to OEL 10 ng/m³ (OEB 6);
payload–linkers for ADC; oligonucleotides; cryogenic chemistry down to −90°C; broad synthetic chemistry; particle engineering and polymorph control; full analytical development and stability.

API Manufacturing

Starogard Site View

Warsaw Site View