Solid state chemistry
- Particle size modulation and optimization
- Polymorph study and crystalization, new salts
- Co-crystals and adducts
FDA-approved and cGMP-Compliant production site
ABOUT USDelivering products to pharmaceutical companies worldwide. We are present on 6 continents, in 60+ countries, and our market share is constantly growing. Our well-balanced and expanding portfolio, along with our scientific know-how and experience, allow us to offer attractive solutions for drug developers;
API development to FDF formulation and manufacturing, scale-up capabilities based on in-house or external custom developed technologies, to regulatory support;
Regular FDA audits enabled us to register and sell a number of APIs in the US market. At Polpharma quality comes first.
Our API Contract development and manufacturing service is dedicated for clients looking for European manufacturing site. We invest in innovative technologies which enhance production efficiency, the comfort of medication delivery and safety of our processes for humans and the environment.
SEE MOREThe use of hazardous chemistry has an aim to reduce the number of synthesis steps as well as the amount of impurities. Our key hazardous chemistry includes:
Polpharma utilizes up-to-date technologies, which ensure the safety of products, employees, and the
natural environment.
We have the capabilities to provide customers with materials ranging from clinical quantities up to
in-market supply. We have full and vertical integration of processes from R&D, pilot plant, scale-up
to the manufacturing leverage of our competences in place so that cost-effective and on-time
solutions are delivered to our partners. API manufacturing is carried out in cGMP-compliant and
FDA-approved multipurpose plant.
Equipment type:
Operating ranges:
Operating ranges Pilot Plant:
Polpharma is engaged in efforts to make its environmental contribution more extensive than ever. We pledge to contribute to a sustainable future for the environment through technological innovation that reduces pollution. We follow the European ISO Standards.
Our products are manufactured in accordance with the most stringent
requirements of our customers and health authorities.
The key to our success is the combination of experience
and expertise of our own research team as well as effective
cooperation with scientific institutions.
We deliver a broad range of added value services to your business: technology development strategies for first generic launch for IP-regulated markets and for early launch in non-IP and non-regulated markets as well as API differentiation.
SEE MOREDevelopment and commercialization of new, attractive APIs, highly qualified professionals as well as strategic partnerships are priorities of the POLPHARMA API R&D Department.
SEE MOREPolpharma API Unit is world-class provider of high-quality products and services
with customized support as well as its international and professional sales team.
Possessing strong R&D centers is able to provide Partners with tailor-made
solutions addressing all of their business needs.