Saneca Pharma receives confirmation of multi-dosage cGMP approval for Russia

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.
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.
Related News
-
News Eli Lilly gets ready to launch five new drugs in 2023
Eli Lilly, the American pharmaceutical company (IN, USA) are gearing up for a big year ahead, with hopes to launch five new drugs and capitalise on growing obesity and Alzheimer’s disease markets. -
News Amgen buys Horizon for $27.8 billion in bold step into the rare disease market
Amgen Inc buys pharmaceutical company Horizon Therapeutics in a multibillion-dollar deal, in hopes to capitalise on it's portfolio of drugs in the highly sort after rare disease market. -
News Pharma Supply Chain People Moves
The latest appointments and promotions across the pharmaceutical supply chain. -
News Merck to donate new Ebola vaccine to defend against outbreaks in Uganda
Pharmaceutical giant Merck has announced they will be speeding up the processing of a new vaccine against the latest strain of the Ebola virus, to be donated to a global non-profit organisation for distribution -
News CPHI Podcast Series: Driving innovation with pharmaceutical startups
The latest episode in the CPHI Podcast Series explores how startups are driving innovation by taking high-risk approaches and doing business with greater agility. -
News Greener and efficient processes: Quaternary Ammonium Salts
Quaternary Ammonium Salts play a crucial part in Organic Chemistry processes at many major industries. Discover why.
-
News Biosimilars save patients $11B annually, but barriers to adoption remain in US market
Biosimilars introduce competition into the biologics market, driving down prices and increasing patient access. -
News WHO recommends use of two monoclonal antibody treatments against Ebola
The health body recommended use of treatments by Regeneron and Ridgeback Bio
Recently Visited
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance