As the Pharma Centre of Excellence within the Schur Flexibles Group, Danapak Flexibles offers a broad range of complex and high-quality laminates for the pharmaceutical and healthcare market segments.
The inroad to the pharmaceutical industry started with development and manufacturing of high barrier laminates to the transdermal therapeutic industry, in which Danapak Flexibles has been the global market leader for decades.
Our expertise and competencies have successively been extended with development, manufacturing and quality control of additional complex laminates for various product applications within the pharmaceutical and healthcare market segments.
High barrier child resistant lidding materials for blister packaging, sealing against all common materials such as e.g. PVC/PVDC, PET and PP is the latest product introductions by Danapak Flexibles.
Read more about our specialized competencies within selective product applications:
As a specialized manufacturer of complex laminates – we focus on matching the strict regulatory requirement of both national and international authorities.
REGULATORY IN SHORT
- Drug Master Files on selective TDS products
- Extractables testing on key TDS products
EMA: EMEA/CVMP/205/04 /CPMP/QWP/4359/03
MWTR USP <671>
- CR testing in accordance with EN 14375/US 16 CFR§1700.20 on key TDS products
- Biological Reactivity - USP 87 (in vitro) & 88 (in vivo)
- Food stuff compliance – EU regulations