“Replek” confirms for the fifth time its compliance with the highest European standards for quality, safety and good manufacturing practice. The latest certification with the EU GMP certificate is proof of the company’s continuous commitment to improving production processes, which emphasizes its reliability and professionalism at every stage of production. The new, fifth in a row, EU GMP certificate includes the expansion of the scope of production with three new forms, namely suppositories, vaginal suppositories, as well as granules for oral use (sachets). This is confirmation of the continuous expansion of capacities with new pharmaceutical forms, which is the result of intensive investments in the modernisation of production lines, the application of state-of-the-art technologies, as well as continuously enhancing employee expertise.
In their closing remarks, the inspectors highlighted that “Replek” demonstrates a high level of maturity in the implementation of good manufacturing practices, highly standardized operational processes, as well as a robust quality system, which emphasizes the reliability and professionalism of the company at every stage of its operations. The certificate has already been officially published on the database of the European Medicines Agency (EMA).
“The new EU GMP certificate is a confirmation of our long-term commitment to quality, innovation and safety of the manufacturing portfolio. The expansion of the manufacturing scope is the result of continuous investments in technology and knowledge, as well as the dedication of the entire “Replek” team. The certificate is a recognition that further strengthens the trust of patients and partners, and confirms the company’s position as modern, competitive and ready to respond to the strictest European and international standards. It is a recognition that is the result of continuous investments in human capital, employee expertise and innovative technologies,” said Dushan Pecovski, CEO of “Replek”.
This achievement strengthens the position of “Replek” as a reliable and credible partner in the European and international markets, while reaffirming the continuous commitment to applying the highest standards in all segments of the operational processes. The new certification further strengthens the strategic positioning of “Replek” in the 450 million-consumer European market, where the company already places a significant part of its portfolio. This European GMP certificate also serves as a reference for partners from a large number of other markets, expanding opportunities for the placement of “Replek’s” products in additional countries.
This achievement confirms the company’s long-term strategy for sustainable and stable growth and development, strengthening its position in international markets, where “Replek” places over 75 percent of its portfolio and continues to increase its share through high consumer trust. Continuous improvement of high-quality standards and compliance with European regulations are an integral part of “Replek”‘s corporate strategy. The quality of manufacturing is also reflected in the company’s financial results for 2025, with a significant improvement in profitability, i.e. growth of 39% compared to 2024.