Polpharma API

Poland Europe

Polpharma API

part of Polpharma Group

About the plant

Polpharma API is a part of Polish leading multinational pharmaceutical group trusted by millions of patients and business partners for over 90 years. Polpharma API CDMO. Thanks to over 75 years of experience in process development, scale-up and cGMP manufacturing, we support both emerging and established pharmaceutical customers in the development and commercialization of their small molecule API clinical candidates. At our FDA-approved plant located in Central Europe, we provide end-to-end solutions from API development to scale-up allowing smooth process transfer for commercial-scale manufacturing capabilities, with world-class regulatory support. Our strong R&D management team, experienced in the development of chemical processes and complex projects, provides a wide range of solutions to our customers, applying a variety of chemical reactions and conditions, including cryogenic, High Pressure, strong base reactions, and tailor-made particle size distribution modifications. At Polpharma quality comes first. Regular FDA audits prove our reliability and credibility towards business partners around the world. Our team of highly qualified, skilled and enthusiastic experts combined with state-of-the-art equipment and facilities provides our partners with an outstanding customer experience.

We are one of the leading European CDMO companies with over seven decades of experience in supporting patients’ health with high-quality APIs.

We offer comprehensive capabilities that span a broad spectrum of cutting-edge technologies and end-to-end solutions—from process development to large-scale commercial production. Our expertise includes:

High Potency APIs (HP APIs)
Payloads & Linkers
Oligonucleotides
Cryogenic processes

Compliance

EMA (EU GMP)
FDA (cGMP)
ECOVADIS

Activity

Injectables, FDF / DRUG PRODUCTS, SERVICES, OLIGONUCLEOTIDES manufacturing

Features

Uses: Human
Toxicity (OEB classification): 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
Controlled substance: N/A
BSL: N/A
Therapeutic areas: (N) Nervous system
Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada)

Batch Size / Reactor

Small, Medium, Large

Services

Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Preformulation studies, R&D, Formulation / Galenic design, Process development, Process optimization, Process validation, Lyophilization cycle development, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Scale-up, Batch records, Analytical methods development, Analytical methods validation, Analytical methods transfer, Batch certification / release, GMP documentation, Purity / Potency, Oligonucleotides & Nucleic acids, API / Excipient – Liquid, API / Excipient – Solid