The manufacturing authorization of AS Kevelt permits manufacture of sterile small-volume parenterals, sterile semi-solid forms and biological medicinal products as well as repackaging and relabeling of medicinal products in immediate packages.
AS Kevelt holds a wholesale distribution authorisation of medicinal products. We are licenced to import medicinal products from outside the EU and release/certify batches for EU market.
AS Kevelt is also authorized to manufacture and import human medicinal products for clinical research.
On a contractual basis AS Kevelt has produced different sterile medical devices (stem cell cryopreservation solutions) and non-sterile semi-solid cosmetic products.
Our team has in-depth knowledge and long-term practical experience of aseptic manufacturing. The production of sterile medicinal products is supported by in-house quality and microbiology labs, quality systems and a team of highly skilled technicians to support the manufacturing needs.