Russian demand for pharma products outweighs isolationist policy

Slovakian contract manufacturer Saneca says the opportunity to tap the Russian market is huge despite protectionist policies and changing GMP inspection requirements.

According to a recent report, the Russian pharma market is growing at an Annual Growth Rate (AGR) of 7.8% and is expected to be worth RUB 2.22 trillion ($38bn) by 2021.

Protectionist measures introduced in 2011 looked to increase local drug manufacture and reduce reliance on imports have led to a number of Big Pharma forming collaborations with domestic drugmakers in order to tap the market opportunities. Pfizer, for example, teamed with Russian pharma firm NovaMedica in May to build an aseptic manufacturing plant in Kaluga.

But according to contract development and manufacturing organisation (CDMO) Saneca Pharma, there is still an opportunity for foreign firms to supply the Russian market.

While “Russia has a policy whereby they are encouraging companies to manufacture in Russia by 2020,” CEO Anthony Sheehan told this publication, “as is the case in other countries, it is almost impossible for one country to be completely self-sufficient in these terms, and it relies heavily on a number of variables, for example type of product.”

He added the opportunity continues to present itself despite new GMP inspection requirements being implemented by Russian authorities.

According to Sheehan, facilities supplying to Russia now have to be inspected by Russian authorities whereas in the past being GMP certified in your country of operation was enough.

Saneca recently had its facility in Hlohovec, Slovakia – about 50km northeast of Bratislava – approved by Russian regulators to make solid, semi-solid and liquid dosage forms and is now producing a large number of SKU’s for the Russian market.

Under the new requirements Russian authorities will inspect a facility a minimum of once every three years, as well as whenever a customer makes a new product filings in Russia

“We are also expecting another audit next year from the Russian authorities linked to new branded generics launching in Russia by another one of our customers,” said Sheehan.

Having already established itself as a supplier for the Russian market, he said his firm is in an enviable position of being a gateway to the lucrative market. However, the size and complexity of the region means there is ample opportunity for both itself and other European CDMOs to grow further in Russia.

“We are hoping to continue our growth in Russia and we already have a number of projects in the pipeline.”

Source