Our Linz facility provides process development and chemical production of intermediates and APIs for clinical and commercial supply under cGMP and ISO conditions, combined with the ability to solve complex challenges for our customers. Alongside our Regensburg, Germany and Florence, SC (both East and West) sites, Linz is part of our fully integrated global network of API facilities across North America & Europe.
The Linz facility is located in ChemiePark Linz, which features over 40 science, healthcare, and pharmaceutical companies.
- Small molecule and polymer API production for clinical and commercial materials (cGMP, Halal, Kosher)
- Production scales ranging from 100 kg to hundreds of metric tons
- Optimization and upscaling of chemical processes, QbDapproach (Quality by Design)
- Process development from early clinical phase up to commercial production
- Analytical method development and phase appropriate method validations Proven Acceptable Range (PAR), process safety studies, stability studies and solid state investigations
- Micro reactors/flow chemistry for developmental quantities and commercial productions
- Process transfers
- Raw material sourcing and outsourcing, external manufacturing
- Registration, validation, product launch
- Support customer’s filing activities (CMC, DMF) -FDA, EMA, PMDA, etc.
- Regulatory support (audits of any regulatory authorities, registration/validation, ICH stability studies, support and consultancy in filing strategy, filing of regulatory documents for submission [NDA/CMC, DMF])
This site features a strong regulatory inspection history from all major international regulatory agencies, including an FDA inspection in June 2017 with no 483s.
Learn more about the specific equipment and capabilities at this site by downloading our Site Fact Sheet.