The certification clears the contract manufacturing organisation (CMO) to make solid, semi-solid and liquid dosage forms for the Russian market at the plant, which is 50km northeast of Bratislava.
CEO Anthony Sheehan described Russia as a key market for Saneca and its customers, explaining “Russia’s importance to the pharmaceutical producers in Central and Eastern Europe is being increasingly recognised, with significant year-on-year revenue growth.”
The approval comes less than a year after Swiss drug firm Xantis contracted Saneca to make 20 generic pharmaceutical products – including medicines for cardiovascular disease, pain management, and sexual health – for markets in Eastern Europe.
A Saneca spokeswoman told us the Xantis deal and other contratcs it has with customer targeting Russia prompted the inspection.
"Saneca already had a number of products registered in Russia but regulations issued last year mean authorities have to audit all exisiting suppliers, which wasn't the case previously. We are one of the first European companies to achieve the certifcation and meet the stringent new regulations."
Plant expansion
Saneca has made a number of investments at the facility in recent months. In September, it beefed up the plant’s active pharmaceutical ingredient (API) production capacity.
In November Saneca installed technologies for the production of modified-release dosage forms, citing its supply deal with Italy’s Menarini Group as the driver for the investment.
The following month, the CMO announced its intention to further increase API capacity.
The firm said it would add capacity for ‘green’ API manufacturing and the production of anti-abuse technologies for opiate-based drugs in collaboration with partner Tau-Chem Ltd.