We return patients the possibility of arterial blood pressure control with Tiara!16 September 2019
In September 2019 “Pharmaceutical Firm “Darnitsa” PrJSC restored the manufacture of TIARA TRIO® AND TIARA DUO® medicinal products and guarantees the absence of genotoxic impurities in the products released to the market.
On August 06, 2019 the State Service of Ukraine on Medicines and Drugs Control cancelled the permanent ban on the use in the manufacture, sale, storage and use of Valsartan substance manufactured by Mylan Laboratories Limited (India).
As it is known, in December 2018 the State Service of Ukraine on Medicines and Drugs Control prohibited the use in the manufacture, sale, storage and use of all batches of Valsartan substance manufactured by Mylan Laboratories Limited (India) on the basis of the notification of the European Directorate for the Quality of Medicines (EDQM) dated November 19, 2018 regarding suspension of the certificate of conformity R1-CEP 2009-396-Rev 03 for said substance.
The reason was the discovery by the Swiss Official Medicines Control Laboratory (OMCL) of traces of the potentially genotoxic compound of NDEA (N-nitrosodiethylamine) in a higher-than-safe amount in individual batches of Valsartan substance of said manufacturer, and, consequently, medicines manufactured using such substance.
“Pharmaceutical Firm “Darnitsa” PrJSC, as a responsible manufacturer that observes European standards at all stages of manufacturing and quality control of medicines, recalled all batches of TIARA TRIO® and TIARA DUO® products manufactured using Valsartan substance manufactured by Mylan Laboratories Limited (India) and for 9 months took necessary measures to return the medicines to the market to continue treatment of Ukrainian patients.
Assessment of the production facilities and elimination of the possible causes of appearance of genotoxic impurities in Valsartan substance, additional studies to determine the degree of contamination and introduction of control of genotoxic impurities in each batch of the substance enabled Mylan Laboratories Limited (India) to ensure the production of the high quality substance free from genotoxic impurities, confirm its quality and renew the certificate of conformity of the European Directorate R1-CEP 2009-396-Rev 04 as from May 24, 2019.
To confirm that Valsartan substance of Mylan Laboratories Limited (India) contains no genotoxic impurities, the State Service of Ukraine on Medicines and Drugs Control took samples of the substance from “Pharmaceutical Firm “Darnitsa” PrJSC, and “Central Laboratory for Quality Control of Medicines and Medical Products” SE checked them for the content of NDMA and NDEA impurities. According to the results of the check, no NDMA and NDEA impurities were found in all checked batches of the substance.
We would like to note that based on the results of scientific assessments, ЕМА and FDA passed the resolution that companies-manufacturers of all medicinal products containing sartan shall revise the manufacturing processes, establish relevant control measures to ensure the quality of pharmaceutical products without genotoxic impurities and show that their products do not contain genotoxic NDMA and NDEA impurities exceeding established safety limits.