Contract development and manufacturing organisation (CDMO) Saneca Pharma has been granted a multiple dosage form approval for the manufacture and supply of solids, semi-solids and liquid finish dose products to Russia.
The company achieved this cGMP certification following an inspection by the Federal State Institution State Institute of Drugs and Good Practices of Russia.
As one of the first European CDMOs to be successful in meeting the new inspection requirements of the Russian authorities, the approval marks another milestone for Saneca Pharma as it strengthens the scope of its pharmaceutical development and manufacturing services to the region.
Commenting on the certification, Anthony Sheehan, CEO at Saneca Pharma, said: “We are delighted to have successfully completed this recent inspection. Russia is a key market for Saneca Pharma, forming an important part of our growth strategy. The certification demonstrates our commitment to meeting the needs of our growing client base in the country, while supporting customers in achieving compliance with various global regulatory authorities.”
“Russia’s importance to the pharmaceutical producers in Central and Eastern Europe is being increasingly recognised, with significant year-on-year revenue growth. Successfully passing this inspection is a challenging process for companies and it is a testament to both the expertise of our team, our quality systems and the condition of our manufacturing facilities that we have been successful in meeting the standards required.”
The certification covers the manufacture and packaging of hard and soft gel capsules, liquids for external use, semi-solids such as ointments and film coated tablets.
Based in western Slovakia, with close proximity to Vienna, Saneca Pharma offers its customers strong capabilities in solids, semi-solids and liquids, as well as specialist expertise in the development and manufacture of opiate APIs and finished dosage forms from farm to pharmacy.