Russian Federation approves multi-dosage cGMP certificate to Saneca Pharma

Saneca Pharma announced that after an inspection Russian Federal State Institution ‘State Institute of Drugs and Good Practices’ has granted them multi-dosage cGMP certificate. cGMP certificate is a multiple dosage form approval for the manufacture and supply of solids, semi-solids and liquid finish dose products to Russia.

As one of the first European CDMOs (contract development and manufacturing organization) to be successful in meeting the new inspection requirements of the Russian authorities, the approval marks another milestone for SANECO Pharma as it strengthens the scope of its pharmaceutical development and manufacturing services to the region.

SANECO Pharma CEO, Anthony Sheehan said that they are delighted to have successfully completed this recent inspection. Russia is a key market for SANECO Pharma, forming an important part of their growth strategy. The certification demonstrates their commitment to meeting the needs of their 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 Recognized, 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, Their quality systems and the condition of their manufacturing facilities that they 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 dry as ointments and film coated tablets.