Who We Are
Global Life Science Company
Custom Chemical Development
Ingredient (API) Manufacturing
SK biotek is a global life science company driven by desire and passion to help enhance and extend patient’s lives. We are renowned for custom chemical development, advanced intermediates and active pharmaceutical ingredient (API) manufacturing. Our array of solutions and services, unique technologies and expertise, commitment to operational excellence, dedication to service delivery and complete customer satisfaction, help to create and successfully launch new therapeutics for our customers into global markets.
SK biotek Ireland is based in Swords, Co. Dublin – less than 6 kilometres from Dublin Airport – nestled between the US and Continental Europe. Our location’s proximity to the European headquarters of numerous global pharmaceutical companies, who have chosen Ireland to base their external manufacturing groups, enables us to build and grow strong relationships with our customers.
Our Swords Campus has a strong legacy and a rich history with over 50 years of active pharmaceutical ingredients (API) manufacturing experience. It is the birth place of some of the world’s leading therapeutics. A plant renowned for providing customers with both process development and commercial manufacturing expertise; its robust adherence to cGMP standards ensures right first time.
As leaders in continuous improvement, Swords Campus became the launch and manufacturing site for APIs for one of the world’s leading pharmaceutical companies as well as its Manufacturing, Science and Technology (MS&T) Centre of Excellence for APIs. As a result the Swords Campus has built exceptional technical capabilities within the MS&T group, with extensive experience in custom development from clinical phases to commercial launch, scale-up for products and manufacturing for global pharmaceutical markets. We are a world-leader in continuous flow processes from development to commercial manufacturing. Our constant innovation and development of improved processes ensures the manufacture of API in a cost efficient manner.
The wealth of experience, expertise and talent developed over the last 50+ years ensures quality and reliability of all processes which are paramount in the regulatory approval process and the transition to commercial manufacturing. Our Campus’ quality track-record and systems, as well as its strong compliance reputation is renowned. Our strict adherence to standards and strong reputation gives customers peace of mind including the reduced risk of regulatory agency observations and of course patient safety. We are regulated by numerous regulatory agencies e.g. FDA, HPRA, Japan’s PMDA and Korea’s MFDS. Our quality team deliver on regulatory approval processes and inspections; the depth and breadth of their knowledge, responsiveness, dependability, professionalism is what our customers value by their side, delivering exceptional quality and service, helping them to quickly and cost-effectively achieve their objectives.
Safety is a core value for us, both our employees and our wider community. We adhere to multiple safety and environmental standards; we hold an Industrial Emissions License from the EPA and are certified by SGS to ISO 14001 Environmental Management Systems Standards.
As an SK biotek Ireland customer we commit to work with you and stand over your product as if it were our own; after all we have been doing it for over 50 years’ producing the world’s most recognized drugs.