Development and production of APIs
We pay special attention to APIs used in our medicinal products. For the most part, we develop and manufacture APIs ourselves. This process includes developing synthesis procedures, optimising technological procedures, and transferring to production scale. Supervision over manufacturing operations, safety and quality of APIs is of utmost importance to us. This reduces our dependence on external suppliers.
The synthesis of our APIs takes place over several extremely complex reaction stages. Each stage is under stringent control. An API is formed under optimal reaction conditions using chemical transformation of two or more substances (chemical compounds, intermediates). We use innovative solutions to overcome patent restrictions.
We use our own synthesis procedures and cleaning technologies to ensure our APIs are of ultra-high purity. Using the most sensitive analytical techniques, we ensure the absence of critical impurities and compliance with the highest quality standards.
APIs manufactured,
using our procedures are high-quality, safe, and efficient. We guarantee that based on data obtained during chemical synthesis development and in several controls performed during the preparation process.
We evaluate the impact of individual factors on chemical reactions through different analytical techniques. These play a key role in the development of chemical synthesis and the transfer of processes to a larger scale. We determine the in-process controls for chemical synthesis during production based on these data.
Krka’s APIs are used in our flagship finished products, which include all medicinal products containing valsartan, perindopril, losartan, atorvastatin, esomeprazole, pantoprazole, and clopidogrel.
Because of its high quality, Krka’s valsartan was the only generic valsartan available on the market in 2018. Competitor products were recalled from the market due to impurities. In 2021, the same situation arose concerning some other sartans and other medicinal products. Consequently, ensuring the absence of genotoxic impurities has become one of the priorities in ensuring product quality across all markets.
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In our commitment to healthy living we offer a broad range of high-quality prescription pharmaceuticals, non-prescription medicines and animal health products.
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