Contract development and manufacturing organization (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.
“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,” Anthony Sheehan, CEO at Saneca Pharma, said. “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.”
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.