Saneca Pharma Receives GMP Certification from Russian Regulator

PTSM: Pharmaceutical Technology Sourcing and Management

Saneca has been granted approval to manufacture and supply multiple dosage forms to Russia.  

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 received this cGMP certification following an inspection by the Federal State Institution ‘State Institute of Drugs and Good Practices’ of Russia.

The certification covers the manufacture and packaging of hard- and softgel capsules, liquids for external use, semi-solids such as ointments, and film-coated tablets. Achieving this milestone enables Saneca Pharma to strengthen the scope of its pharmaceutical development and manufacturing services to the region.

Commenting on the certification, Anthony Sheehan, CEO at Saneca Pharma, said in a press statement, “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.”

Saneca Pharma specializes in the development and manufacture of opiate APIs and finished dosage forms, including solids, semi-solids, and liquids. The CDMO is based in Western Slovakia, with close proximity to Vienna.

Source: Saneca Pharma