Krka d d : sartans not affected by the recalls due to azido impurities
October 25, 2021 at 04:04 am EDT
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22. 10. 2021
Krka's sartans not affected by the recalls due to azido impurities
After the European Directorate for the Quality of Medicines and HealthCare (EDQM) alert due to confirmation of mutagenicity of varied azido impurities in sartan active substances (APIs) with a tetrazole ring, many batches containing valsartan, irbesartan and especially losartan of various manufacturers have been recalled from the markets.
Krka, d. d., Novo mesto, Slovenia has implemented all necessary measures and conducted necessary testing to prove proper control over the mentioned azido impurities. Krka, d. d., Novo mesto, is not affected by the aforementioned recalls.
Krka, d. d., Novo mesto, hereby declares that all batches of its medicinal products, including products with APIs valsartan, candesartan cilexetil, losartan potassium, olmesartan medoxomil, irbesartan hydrochloride and telmisartan are safe, effective and of high quality. They have been continuously available for many years on the markets without restriction.
Krka, d. d., Novo mesto, Slovenia strictly follows the instructions from EMA and fully cooperates with the Slovenian National Agency and other competent authorities around the world. We are well aware of the complexity and seriousness of this matter and, therefore, closely monitor any emerging developments regarding this issue.
For further information please contact: info@krka.biz
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KRKA dd published this content on 25 October 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 October 2021 08:03:08 UTC.
Krka dd Novo Mesto is a Slovenia-based company engaged in the production of pharmaceutical preparations. The Company operates through four segments: Prescription Pharmaceuticals that includes medicines for the treatment of cardiovascular diseases, alimentary tract and metabolism and drugs for diseases of the central nervous system, among others; Non-prescription Products, providing vitamins and minerals, cough and cold products, analgesics, sore throat products, among others; Animal Health Products, which offers general anti-infectives and antiparasitics for animals; Health Resort and Tourist Services consisting of Spa resorts in Smarjeske Toplice, Dolenjske Toplice, Strunjan, Novo Mesto and Otocec. Krka dd Novo Mesto is a controlling company of the Krka Group that includes two subsidiaries in Slovenia, Terme Krka doo and Farma GRS doo, and over 20 subsidiaries abroad in such countries as Croatia, Germany, Sweden, Poland, Spain, United States, Ireland, among others.
KRKA, D. D. 
