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Russia has the potential to dominate API production, say PMR

Market analysts PMR have launched a new paper highlighting the potential for API production in Russia, Ukraine and the Baltics.

Though API (active pharmaceutical ingredient) production is still predominantly a Chinese and Indian industry the authors claim that recent sourcing issues – such the Chinese Heparin case – have led companies to look elsewhere.

Now through analysis of business and market strengths and weaknesses, as well as obstacles and availability of resources, polish-based market experts PMR project Russia and the Baltic States as viable alternatives for the entire API process; from sourcing to contracting to manufacture the finished dose product.

Monika Stefańczyk, Head Pharmaceutical Market Analyst and coordinator of the report, largely attributes this conclusion to the new Federal Target Programme (FTP) Strategy for the development of the pharmaceutical industry of the Russian Federation between now and 2020.

As part of the $1.3bn (€900m) project, Russian PM Vladimir Putin has promised to construct 200,000m² of facilities producing sterile and non-sterile pharmaceuticals.

Stefańczyk wrote: “The Federal Target Programme (FTP) ‘Strategy for the development of the pharmaceutical industry of the Russian Federation between now and 2020’ (Pharma 2020) is designed to encourage the transition of Russia’s pharmaceutical industry to an innovative development model.

“Russian companies might, therefore, be more attractive partners in the future.”

All or nothing

The report follows Putin’s warning to January when he put pressure on drug makers in a bid to speed up the slow burning CIS development as producers of pharmaceuticals.

He issued the statement: “There will be restrictions for (global drugmakers) in the Russian market if they do not launch production and transfer technology.”

But even though manufacturers of substances have not only resumed production in Russia and the Baltics, but also broadened the range of manufactured substances, it is estimated a mere 15 per cent of APIs are consumed domestically.

And the report recognises that this could be due to holes in the development plan such as lack of GMP standards, which could well continue to impede development of the Russian pharmaceutical industry.

Of the new 2020 development plan, Stefańczyk told in-PharmaTechnologist: “The government also encourages foreign companies to build factories in Russia.

“This strategy has already led to the situation in which international companies such as Krka, Servier and Hemofarm have already built factories in Russia, and that others, such as Berlin-Chemie/Menarini, Krka and Teva are planning to do so.

“But in order to persuade companies to buy APIs in Russia instead of India or China, Russia massively have to implement GMP rules more widely.”

Stefańczyk also told in-PharmaTechnologist that she thinks the government’s plans to “increase domestic production to 50 per cent are too optimistic, but indeed they declare huge amount of money to be spent on this purpose.”


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