Bosnalijek receives EU GMP certificate for new facility, enabling export of all products to EU market

SARAJEVO, (Patria) - The largest domestic pharmaceutical company Bosnalijek d.d. Sarajevo has successfully completed the process of obtaining the EU GMP certificate for its liquid and semi-solid dosage form production facility, which was opened last year.

This ensures that the full capacity of the newly opened facility can be utilized. The facility, into which 50 million KM was invested, has a maximum annual production volume of 34 million packages of liquid and semi-solid dosage form medicines, which is a five-fold increase compared to previous capacities.

With the successful certification of the new facility, the entire production process at Bosnalijek is aligned with EU GMP rules and guidelines, meaning that all conditions have been met for all products to be placed on the European Union market, Bosnalijek announced.

This effectively completes a significant development cycle for the company, as Bosnalijek has held similar certificates for some time, ensuring exports to markets on three continents.

Company Director Nedim Uzunović points out that following the receipt of this certificate, the first concrete deals in the European Union market will follow very soon, which will ensure further expansion of exports and company development, as well as the creation of new jobs.

"By obtaining this certificate, it has been confirmed once again that all processes within our company are aligned with the best global practices and standards, and that all our products are of the highest quality. Our main priority is to meet the highest expectations of our product users, which we ensure through the production of highly effective, safe, and quality medicines, as confirmed once again by obtaining this certificate. Our strategic commitment is to open new export markets, and we have now created all the necessary prerequisites for export to all European Union countries, both for our own products and for contract manufacturing and cooperation with major global pharmaceutical companies. We are proud that Bosnalijek is one of the leading exporters in BiH, and the largest when it comes to medicine production. The amount of half a billion KM in exports over the past five years, with continuous annual growth in export value, best illustrates this," said Uzunović.

After successfully obtaining the EU GMP certificate, Bosnalijek also has open doors to initiate the process of obtaining the necessary approvals from the US FDA, based on the Agreement on Mutual Recognition of Inspections of Manufacturing Facilities for Human Medicines between the USA and the EU, which would create the conditions for meeting the formal requirements for export, not only to the United States but practically to all countries in the world.