The largest domestic pharmaceutical company Bosnalijek successfully completed the process of obtaining EU GMP certification for the facility for the production of liquid and semi-solid pharmaceuticals, which opened last year. In this way, it was ensured that the full capacity of the newly opened facility could be fully utilized, in which 50 million BAM was invested, with a maximum annual production volume of 34 million packages of liquid and semi-solid pharmaceutical forms, which is a fivefold increase over the existing capacities.
With the successful certification of the new plant, the entire production process at Bosnalijek is in line with the rules and guidelines of the EU GMP, which means that all the products can be placed on the European Union market.
This has practically rounded off a significant development cycle for the company, given that Bosnalijek has previously obtained similar certificates that guarantee it exports to countries on three continents.
The director of the company Nedim Uzunovic points out that after obtaining this certificate, the first concrete jobs in the European Union market will soon follow, which will ensure further expansion of the company’s export and development, and creation of new jobs.
“By obtaining this certificate, we have once again confirmed that all processes within our company are in accordance with the best world practices and standards, and that all our products are of the highest quality. Our main priority is to fulfill the highest expectations of the users of our products, which we ensure through the production of medicines of high efficiency, safety and quality, which has been confirmed once again by obtaining this certificate. Our strategic commitment is to open new export markets and now we have created all the prerequisites necessary for exporting to all EU countries, both in terms of our own products, but also when it comes to contract manufacturing and cooperation with major world pharmaceutical companies,” Uzunovic said, Ekapija reports.
After successfully obtaining EU GMP certification, Bosnalijek opened the door 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 of human medicines between the USA and the EU, which would create the conditions for meeting the formal requirements for export, not just to the United States, but to virtually every country in the world.