Production of Medicines Tailor-Made for Europe

Cutting-edge Hemofarm factories, operating in compliance with the highest international pharmaceutical standards, as well as highly-qualified professional staff, have become a guarantee of the top-notch quality of medicines for numerous European countries, owing to which the production of more than 230 medicines was transferred from the factories located in the European Union to Hemofarm’s manufacturing plants over the course of the last 10 years.

World-class Quality in Local Setting

In the last year alone, 245 million packs of medicines were produced in Hemofarm, rendering 5.6 billion units if presented in the number of individually produced tablets, bottles or tubes, more than 60 percent of which is earmarked for the European market.

’The percentage is even higher in some plants. As a matter of fact, as much as 80 percent of production volume of the Vršac-based Solid Dosage Forms Plant, as well as Hemofarm’s Plants in Šabac, Banjaluka and Podgorica, is presently produced for the European market’, Olivera Vujnović, Pharmaceutical Technology Engineer and Specialist, and Manufacturing Science & Technology Cluster Head Southeast Europe and Ukraine, said.

Standards, Before All

Hemofarm has been a member of the German STADA Group, one of the largest generic pharmaceutical companies in the world, since 2006. The first transfers of pharmaceutical production from the factories located in the Western Europe to Hemofarm’s plants were initiated more than 10 years ago, and the compliance of Hemofarm’s factories with the strictest international pharmaceutical standards was one of the essential conditions.

’We are, primarily, talking about Good Manufacturing Practice (GMP) standards, the purpose of which is to ensure that production is consistently performed in accordance with controlled, clearly defined and standardized procedures. The entire system has been designed in such a manner to minimize all potential risks in production process, while covering all production aspects from starting material, space, processes, equipment, to staff. Certification is conducted periodically by the authorized European institutions which perform detailed audit of compliance with all GMP requirements. The auditors from the German region Hessen are our most frequent visitors’, explained Olivera Vujnović, who has been a member of the Transfer Team, that has been endeavouring, through its knowledge and dedicated work, to transfer as many products from the European Union to Hemofarm’s manufacturing plants ever since the beginning of the integration of Hemofarm into STADA Group.

Equal Quality of Medicinal Products for All

Over 230 different medicines are presently manufactured in Hemofarm for the European market, many of which are produced in huge quantities to meet the demand as per tenders and large health insurance funds such as AOK, BARMER, DAK, HEK, IKK….

‘Based on formulations obtained from STADA, we produce medicines for numerous European countries, including Austria, Germany, Italy, France, Switzerland, Poland, the Czech Republic, Slovakia, as well as Denmark, Sweden, Finland, the Netherlands, Ireland, Portugal, Spain, England….We produce exactly the same medicines, based on the equivalent formulations and same starting materials also for the Serbian market, with an inscription on the pack in the Serbian language as the only difference’, Vujnović pointed out.

Production transfer process is very demanding, and preparatory activities per medicine take about two years.

’Each of those medicines must be identical to the medicine which was previously produced in a factory in Europe. It is not sufficient that a product has only the identical formulation or the demanding content of the active substance, but it also needs to have the identical stability features under different humidity and temperature conditions, identical active substance dissolution over the expected period, and so on. If you take into account that we are talking about hundreds of different medicines, you can only assume what a strenuous job it is’, Olivera Vujnović, industrial pharmacy specialist, added.

People as the Biggest Potential

Highly-qualified employees in Hemofarm, organized in multidisciplinary teams, are certainly the key to company success.

’A multidisciplinary team singles Hemofarm out among regional pharmaceutical companies, in which the experts in only one field are generally favoured. Our team comprises not only technology, pharmacy, chemistry, biology engineers, but also mechanical and electrical engineers, whose role is important, from purchasing, installing and maintaining highly-sophisticated equipment, to solving serious engineering problems. Their knowledge is also indispensable in ensuring the specific manufacturing conditions in terms of adequate humidity and temperature, designing and making the corresponding tools for production of medicines, etc.’, our collocutor explained.

Continuous upgrading of equipment is indispensable for high-quality pharmaceutical production

’The latest generation equipment provides vast new options which ensure a safer production of medicinal products. We have been investing millions of euros at an annual level. However, our goal is to encourage as intensive transfer of pharmaceutical production from European factories to our manufacturing plants as possible, and thereafter export those medicines to the European Union… That is good for Hemofarm, that is good for the Serbian economy’, Olivera Vujnović stated.