Dr. Khashayar Karimian, the project executive who holds the second place for innovation at the 30th International Khwarizmi Award, told Mehr News that the ‘Synthesis of Anti-Cancer Pharmaceutical Active Ingredients’ project has been conducted by observing the international regulations for production of pharmaceutical active ingredients according to the International Commission on Harmonization (ICH).
“We also produced three validation packages to conduct short- and long-term stability studies and compiled medical records (Drug Master file, DMF) for each of these products in accordance with ICH regulations,” he said.
He noted the important achievements of this national master plan, including: obtaining the patent for three international inventions about better methods of production, production of high-risk pharmaceutical active ingredients at industrial scale for the first time in the country under Closed System MGF, and design and production of closed system manufacturing machinery.
“We have also signed a contract with India to export the anti-cancer pharmaceutical active ingredients to that country,” he added.
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