The main driving force behind investment into Russia is the Pharma 2020 plan, introduced in 2009. The state-run plan contains goals of producing 90% of vital medicines within Russia to become less dependent on imported medicine. The Russian government has also prioritized the need for the domestic production of fine chemicals. Another key measure for the plan is for regulatory harmonization and the implementation of a good manufacturing practices (GMP) program to be on par with E.U. and U.S. requirements in quality for drug substance manufacturing.
The number of active pharmaceutical ingredients (API) manufacturers in India and China make up almost three-quarters of the global API manufacturing landscape. There is minimal local API production in Russia, and there are almost no companies that have experience in highly regulated markets. Although the number of API manufacturers in Russia is the highest in the region, followed by Ukraine, companies with experience supplying regulated markets are more prevalent in Central and Eastern Europe (CEE) countries.
While the region may have fewer companies than India and China, Russia and CEE have many that are attracting significant investment. Numerous foreign companies have invested in building or purchasing facilities in Russia and CEE. At the end of 2016, for example, Sun Pharma made a $24M acquisition for a stake in JSC Biosintez, the Russian API manufacturer. Saneca Pharma is expanding the small batch API production at its Hlohovec, Slovakia site. While companies such as Sanofi-Aventis and Novo Nordisk have invested in insulin facilities in Russia, biologics and biosimilar products also offer an area of investment where Russia has shown promise. Russian companies are also looking at markets overseas. Pharmsynthez has announced it is looking for small, growing and profitable companies that own production facilities. Many other Russian companies are looking to expand beyond Eastern Europe into Asian markets, while a number of Russian companies have announced that they are expanding and modernizing their facilities in order to meet with global GMP requirements.
The government is encouraging foreign investment by creating dedicated economic zones offering tax and trade incentives. In order to grow domestic manufacturing the Russian government is continuing to move regulatory legislation forward regarding fine chemical production and R&D hubs. It is likely more companies will find complementary partners within the region as it offers local market access and geographic expansion while seeing continued governmental support and incentive.
For more insights on the global API manufacturing industry, connect with the author of this article Joshua Gilpatrick and other generics and API experts at CPhI Worldwide. Schedule an introductory meeting today, or join us for informative, data-driven presentations onsite.
This article was originally published by Chimica Oggi – Chemistry Today, a peer reviewed, bimonthly journal, of the TKS TeknoScienze Publisher. Read the original article here.