As a pharmaceutical contract manufacturer with a manufacturing license in accordance with § 13 AMG, Topmedicare GmbH specialises in the production of sterile drug products in small batches. With the construction of our new sterile production facility in Saarbrücken in 2016, a production environment was created where diverse manufacturing processes can be implemented according to the latest scientific and technical standards.
In doing so, we implement the regulatory requirements with commitment and a sense of proportion, so that we can offer our customers economic solutions with the highest possible standards of safety and quality.
Our QM system, which covers the complete process chain and forms the basis for reliable processes and reliable results, makes an important contribution to this. We perform patient specific compounding of cytostatic and antibody preparations for pharmacies. Moreover we offer our customers in the pharmaceutical industry the production of investigational medicinal products as well as authorized drugs and their intermediates.
Topmedicare offers its services as a contract manufacturer across the entire product development chain:
- Project management and customer support
- Product and process development
- Qualification and validation of equipment and processes
- Procurement of primary packaging and starting materials including supplier qualification
- Quality control – in-house or provided by our contracted laboratories
- Production of small- and large-volume sterile liquid dosage forms, either aseptically filled or terminal sterilised, as well as dosage forms for dermal application in our clean rooms class A to C according to EU-GMP