Our client Trepharm, a Kosovo-based pharmaceutical manufacturer with more than a decade of operating experience, has achieved European Good Manufacturing Practice (EU GMP) certification. EU GMP confirms that medicines are produced and controlled under strict international quality and safety standards. It is a demanding requirement for supplying regulated pharmaceutical markets.
For Trepharm, this is a major step forward. It shows that a manufacturer operating in Kosovo can meet the same regulated production standards expected in international pharmaceutical markets.
EU GMP certification does more than recognise quality. It removes regulatory obstacles, enables product registration in new countries, and allows companies to participate in international supply chains and partnerships that require verified compliance. In practical terms, it enables Trepharm to expand exports to more than 134 countries and to develop contract manufacturing (CMO) activities in regulated markets.
The milestone also has wider regional significance. As Europe seeks to strengthen supply resilience through nearshoring, Southeast Europe is gaining attention as a competitive and well-located manufacturing base. Trepharm’s certification is a clear example that companies from the region can operate at internationally accepted pharmaceutical standards and contribute to European supply security.
Trepharm currently produces and markets more than 120 products, including generic medicines, injectables, OTC products and dietary supplements. Its facilities are organised in segregated production units to ensure controlled material flows and prevent cross-contamination. The company supplies pharmacy chains across the region and exports to markets in Europe, Africa and Asia.
Building on this achievement, Trepharm is preparing a new greenfield investment in Vitamin D API ready-mix manufacturing. The project will expand regional production of pharmaceutical inputs and reduce dependence on imports. It has been selected by the European Commission for support among 450 applications.
ECIKS is acting as strategic and investment advisor in the preparation and structuring of this project, including development of the investment concept, financial modelling, and support for the proposal submitted to the European Commission.
Trepharm’s progress shows that pharmaceutical manufacturing in Kosovo can meet regulated international standards and integrate into European supply chains. ECIKS remains committed to supporting investments that strengthen industrial capability and international competitiveness in Southeast Europe.
