World class service
Polpharma provides a one-stop shopping solution of integrated services ranging from API development
to finished dosage formulation and scale-up capabilities based on in-house or customer developed technology and the support of the registration file.
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Full support from molecule development to drug delivery
We offer:
- Development, production and marketing of generic APIs
- Custom synthesis and toll manufacturing
- Intellectual Property review services
- Non-infringing process development
- US and European DMFs in a common format
- Wide reaction classes in FDA approved facilities
- Multipurpose production lines
- High GMP standards
- Product quality
Cost-effective solutions tailored to the customers` needs
We constantly seek ways to add value to everything that we do for our customers. We ensure to keep our API portfolio updated and expand it with new, attractive compounds.
Our cGMP capacity combined with a short development time and competitive pricing make us a natural choice for pharmaceutical companies interested in outsourcing their manufacturing activities. We have gained an exceptional reputation among our customers worldwide for the quality of our contract manufacturing services.
Out-licensing offer
Our services include EU standard dossiers for finished dosage formulations based on APIs developed in-house or sourced externally. Our out-licensing portfolio secures the most comprehensive offer for our clients.
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. DMF documentation for all our products is prepared in accordance with the latest requirements of EDQM (CEP), ICH (EuDMF, CTD), and FDA (US DMF).
Material and product testing is performed according to the European and United States Pharmacopeias. However, our products can be additionally tested in compliance with the customer’s specifications.