Jun 3, 2013

Alkaloid’s antibiotic for the first time in Germany, France and Austria

After a 3-year procedure of analysis, estimations and controls by expert teams, the placement of Alkaloid’s antibiotic has been approved on the markets in major European countries.

Alkaloid is an export-oriented company that places over 60% of its products in over 30 countries in the world, through its 16 offices outside of Macedonia. In addition to the countries from Southeastern Europe, EU countries are the first on the list of priorities, where Alkaloid obtained over 200 marketing authorizations (licenses for placement of medications on markets), issued by relevant institutions, more than half of which have been obtained in accordance with the strictest regulated EU procedures (Mutual Recognition Procedure and Decentralized Procedure)

The process of harmonization with the EU began in Alkaloid AD Skopje more than 10 years ago. In that respect, the company is fully prepared to adapt the already accepted legal standards and rules of operation, which it practices on the markets in Bulgaria, Romania, Slovenia, the Czech Republic, Poland, Slovakia, and Croatia.

At the end of the previous month, Alkaloid AD Skopje obtained the first license for placement of its product in major European countries, markets of old Europe’s powers: Germany, France and Austria, which in the history of this company is the first individual marketing authorization of medication in these countries.

The medication is Cefadroxil, a cephalosporin antibiotic, known in the Republic of Macedonia as Alicef, indicated for the treatment of respiratory infections, skin infections and soft tissue and urinary infections.

The entire project - from the medication development to the completion of the authorization procedure - lasted around 5 years, starting from market analysis, a careful monitoring of national legal specifications of the aforementioned countries, harmonization of the product with the latest European regulations for pharmaceutical products, as well as proper analysis at Drug Agencies. An estimation of the quality, safety and efficiency of this antibiotic was the subject of analysis by over 40 experts from all drug agencies in the countries involved in the procedure, and the final positive decision was based on the consensus of all countries. This antibiotic will be available on the markets in Germany, France and Austria in September this year.

Pharmaceutical products are the most regulated category of products in the world. Being a controlled, safe and reliable manufacturer of medications, Alkaloid AD Skopje regularly passes the audits by renowned multinational pharmaceutical companies that are our partners, as well as the inspections by several European food and medication agencies.