Alexander Semenov spoke at the round table “Full cycle of API production”

28 November 2023

As part of the first day of the Pharmtech & Ingredients exhibition, a round table was held dedicated to the full production cycle of active pharmaceutical ingredients (API). The president of the Acticomp, Alexander Semenov, spoke at the event. Alexander Semenov.

The round table was moderated by Georgy Khachiyan, editor-in-chief of the Chemical Expert magazine. Among the speakers were: Irina Vendilo, General Director of the Roskhimreaktiv Association, Alexander Pshenichny, General Director of Polisintez LLC, Hermes Chilov, Director of the Research and Development Directorate of Valenta Pharm JSC, Anton Prozumentov, Senior Project Manager of Sibur and others.

As experts noted, the full cycle of API production involves the creation of a full-fledged chain of manufacturers of all components, chemicals of varying complexity (from solvents to intermediates), the development of chemical engineering production, and personnel training. According to the speakers, many of the necessary processes are now in their infancy. During the round table, participants discussed how far Russian companies have progressed along this path, what the results and prospects are.

The first question that was raised for discussion was “How ready is the Russian chemical industry for current production volumes and difficult working conditions?”. In her speech, Irina Vendilo noted that working with the pharmaceutical industry is one of the priorities for chemical industry enterprises, and that the chemical and pharmaceutical industries have many common points. “We are looking for ways and solutions so that our import substitution takes on specific features. It can be seen that an atmosphere of complete trust is now being built between the chemical and pharmaceutical industries,” she emphasized.

Anton Prozumentov noted the need to solve two problems: on the one hand, to “connect” all participants, on the other, to achieve maximum efficiency from all participants at each stage of production, making the internal chain completely local and independent of imports. He also talked about how Sibur saw business in this direction. The company has created a division that specializes in the medical industry, is deeply immersed in pharma, its needs and problems, and sees significant prospects here.

Alexander Semenov agreed with the idea that there are excellent opportunities available to chemical companies at the moment. To confirm this position, he put forward several important theses:

  • The state has approved the “Pharma 2030” strategy, according to which a number of serious preferences will be launched for full-cycle manufacturers.
  • The Ministry of Industry and Trade of the Russian Federation has clearly defined the criteria for the locality of domestic APIs: at least one stage of synthesis leading to a change in the molecule.
  • The “Odd One” program is being prepared for launch, and from the first quarter of 2025, domestic manufacturers will have to adapt to the “new reality.”
  • The list of strategically important medicines is expanding (the norm is laid down in the Pharma-2030 program).
  • Since November 2023, an official experiment has been launched, which is being conducted by the CRPT (Center for the Development of Advanced Technologies). It aims to create a traceability system for the production of pharmaceutical substances.

As Alexander Semenov emphasized, all these events create incentives for the production of chemical components that will be included in the list of active pharmaceutical substances.

Next, Alexander Pshenichny spoke, who noted that at the moment there is no point in organizing the production of all pharmaceutical products. However, with the right positioning and the right selection of partners, Russian companies can compete with Chinese and other foreign manufacturers. “Thanks to the support of the Roskhimreaktiv Association, we were able to produce a product needed by the market, which was not inferior in quality to foreign analogues and was cheaper,” he concluded.

Boris Lalaev, head of the Department of Chemical Technology of Medicinal Substances, Associate Professor at SCPFU, spoke about involvement in the production process and development of technologies within laboratories at universities. “It is worth noting that many requests come not so much from pharmaceuticals, but from the same “chemistry” and related fields. Therefore, the role of such laboratories is extremely high. We believe that in order to improve the production chain, companies should really start looking at the capacity and personnel that are available in our country’s universities,” he commented.

At the end of the round table, talking about whether it is worth focusing on your own technologies or whether it is more profitable to resort to a transfer, the experts agreed that both options will always be unique for a specific intermediate and case in each company.