Growth and sustainability are integral parts of our strategy, guided by our core values. By embedding sustainability in everything we do – from the lab to the patient – we are helping to strengthen good health and well-being. As the result of our in-depth market evaluation the most suitable medicines are outlined for our product portfolio. The safety and eﬃcacy of our products is the top priority.
Manufacturing of pharmaceutical products is subject to very strict quality requirements – GMP (Good Manufacturing Practices), ISO certiﬁcations and the guidelines of the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use). From complex requirements to tight production schedules, we along with our contract manufacturing organizations face stubborn obstacles in ensuring the wellbeing and health of humans while not harming the planet.
Protection against Product Counterfeiting
Product counterfeiting is an enormous problem worldwide. The Falsiﬁed Medicines Directive of the European Union speciﬁes requirements and measures for the veriﬁcation of the medicines. This includes mandatory security features on external packaging, which Kalceks has used for its prescription products since 2019. These data matrix codes are stored in country-speciﬁc databases across the EU. Wholesalers and pharmacies can verify the products authenticity by simply scanning the code.
Product safety monitoring
Our medicines need to be eﬀective in treating the respective disease, while posing as little risk as possible to patients. Therefore, we consistently monitor risks and adverse eﬀects that may arise and take the necessary actions to minimize them. Based on the conditions of regulatory approval, we develop and update educational materials for patients and healthcare providers to communicate any known and potential risks and ways to minimize them for newly approved products.
Our core values – purposefulness, reliability, ﬂexibility and responsive communication – guide us in our daily work deﬁning how we interact with our customers and business partners. We do our business activities to adhere to relevant regulations and ethical standards around the world. We are aware that our company operates in a complex legal environment and incurs various tax obligations with its domestic and foreign business activities. It is our responsibility to ensure compliance with tax legislation in all countries in which we operate and to be transparent.
AS Kalceks as pharmaceutical company without own manufacturing sites, incorporates the green values for everyday oﬃce life, as example, waste recycling. Our logistics team also accurately plans product deliveries in order not to organize useless transportation activities. We also ensure that disposal of unused medicines strictly complies to legislation.
We aim to deliver our products in packaging that is safe and easy for customers to handled. We are working on for employing more eco-friendly materials for secondary packing. Our contract manufacturing organizations are covered by ISO 14001 certiﬁcate to comply with environment standards and to establish processes on improving eﬃciency in manufacturing of products to protect our climate and environment.