Solid state chemistry
- Particle size modulation and optimization
- Polymorph study and crystalization, new salts
- Co-crystals and adducts
European CDMO Partner
and API Manufacturer since 1951
We deliver quality
FDA-approved and cGMP-Compliant production site
ABOUT USWe are:
significant European producer of Active Pharmaceutical Ingredients
Delivering 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;
provider of one-stop shop solution of vertically integrated services
API development to FDF formulation and manufacturing, scale-up capabilities based on in-house or external custom developed technologies, to regulatory support;
reliabile and credibile partner towards business partners around the world
Regular FDA audits enabled us to register and sell a number of APIs in the US market. At Polpharma quality comes first.
06
CONTINENTS
60
Countries
We invest with your future in mind
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.
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Hazardous chemistry
The 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:
- Grignard Chemistry, Hydrogenation
- Strong base handling – Sodium metal, hydride
- Reactions with Lewis Acid
- Reactions with liquid and/or gas ammonia and Chlorine
- Bromination, Bisphosphonation
- Chemoinformatics
- Friedel Crafts Alkylation
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Production facilities
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.
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Our capacity
Equipment type:
- Reactors
- Columns
- Crystallizers
- Centrifuges
- Dryers
- Filter-dryers
- Mills Micronizers
Operating ranges:
- Temp. -20°C to +200°C
- Pressure -1 to +10 bars
- pH in the full range
Operating ranges Pilot Plant:
- Temp. -80°C to +200°C
- Pressure -1 to +10 bars
- pH in the full range
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Green Chemistry
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.
- Integrated Pollution prevention and Control Licence (IPPC)
- Certificate of ISO 14001:2004 (UKAS accreditation)
- Certificate of ISO 18001:2007 (OHSAS and PN-N, UKAS accreditation)
- Waste management (own waste incinerator; capacity 200 kg/h, solids and liquids)
- Sewage management (own waste water treatment plant; capacity 8500 m3/day)
- VOC Emission Control System
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Network of alliances
- Impurity synthesis
- Chiral purification
- Continuous process
- Biocatalysis
- Supercritical fluid chemistry and analysis
- Peptide chemistry
- Polymerisation chemistry
- Supply chain management
Our Products
Quality, optimization and customer satisfaction are the driving forces behind our work
Our products are manufactured in accordance with the most stringent
requirements of our customers and health authorities.
Alimentary tract
& metabolism
& metabolism
Antipyretic, analgesic
and anti-inflammatory
and anti-inflammatory
Antineoplastic
& immunomodulating agents
& immunomodulating agents
Blood & blood forming organs
Cardiovascular system
Genito-urinary system
& sex hormones
& sex hormones
Musculo-skeletal system
Nervous system
Respiratory system
Injectable forms
R&D
Expertise, Development and Cooperation
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.
Competitive competences
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 MOREOur Priorities
Development 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 is a part of Polpharma Group
Polpharma 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.