The facility will carry out the full cycle of industrial synthesis of APIs: from technology development to product release and strict quality control at all stages. The establishment of this new API production is a strategic step in the development of the domestic chemical and pharmaceutical industry, helping to reduce dependence on imports of key components, ensure supply stability, and accelerate the market launch of innovative domestically produced drugs.
The opening ceremony was attended by Anton Alikhanov, Minister of Industry and Trade of the Russian Federation; Ekaterina Zinovieva, Deputy Chairman of the Government of the Moscow Region; and Inna Fedotova, Head of the Khimki City District.
The new complex is equipped with modern flexible production lines and is designed to produce up to 50 tonnes of active pharmaceutical ingredients (APIs) per year. This is a highly automated GMP facility staffed by more than 100 qualified specialists. The total investment in the project amounted to approximately 2 billion rubles.
“Our task is to almost completely replace all active pharmaceutical ingredients used in medicines produced in Russia, and to manufacture APIs within the country. Today’s opening of this production facility is one of the building blocks that will allow us to achieve this goal. Since 2020, we have already opened 20 production sites that are engaged in the manufacture of active pharmaceutical ingredients. And already, more than 63% of essential medicines sold on our market — I mean the public sector — are medicines made from APIs that can be produced in our country,” said Anton Alikhanov.
Andrey Ivashchenko, Chairman of the Board of Directors of ChemRar Group: “The new API production based on modern flexible lines allows us to increase the capacity of ChemRar Group tenfold and to provide a full cycle of development and production for a number of strategically important innovative next-generation medicines. Localization of pharmaceutical API synthesis within the Russian Federation is one of the key conditions for building a strong domestic pharmaceutical industry to ensure the country’s technological sovereignty.”
ChemRar Group is one of but a handful of Russian companies to encompass the full technological chain — from molecular development and synthesis to the in-house manufacture of active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs). Approximately ten next-generation drug candidates are presently in active development across various stages of preclinical and clinical research.