PatheonPatheon NV, a leading global provider of high-quality drug development and delivery solutions to the pharmaceutical sector, has been cited once again as capturing the most outsourced new drug approvals (NDAs) in the US than any other contract manufacturing organisation (CMO) in 2016.

NDAs are authorised by the US Food and Drug Administration (FDA).

The annual 2017 PharmSource CMO Scorecard underscores the company’s leadership position in the CMO sector highlighting the fact that Patheon is supporting approximately 30% of all new drug approvals on behalf of clients in 2016 and has been awarded approximately 25% of all outsourced approvals in the last decade (2007-2016).

“Patheon continues to bring expertise, value and a solid track record in navigating the regulatory needs of clients, resulting in the company gaining a dominant share of product approvals in 2016 and during the last 10 years,” said Michael Lehmann, President, Global Sales and Marketing. “Securing market approval is key to pharma companies’ success and Patheon has the experience navigating the path to a regulatory approval.”

Key findings of the report include Patheon receiving

  • 17 out of 55 (30%) of all outsourced NDA approvals in 2016, four times more than the closest competitor
  • 112 new molecular entity (NME) and non-NME NDA approvals, more than the next six leading CMOs combined (2007-2016)
  • significant awards for solid dose NME approvals, solid dose non-NME approvals and parenteral NME approvals during the last 10 years.

Patheon was the only CMO recognised for having multiple approvals for both drug substance and drug product.

The annual CMO Scorecard analyses the CMO industry, using NDA approvals as a key indicator of performance, with data compiled from a broad array of public sources including regulatory and financial filings, and press releases.