Patheon outsources most NDAs of any provider


Company held approximately 30% of all outsourced approvals in 2016, four times more than the nearest competitor

Global provider of drug development and delivery solutions Patheon captured the most outsourced new drug approvals (NDAs) in the US than any other contract manufacturing organisation (CMO) last year.

The company supported approximately 30% of all new drug approvals on behalf of clients and has been awarded approximately 25% of all outsourced approvals in the last decade (2007–2016).

Patheon received:

  • 17 out of 55 of all outsourced NDA approvals, 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 in the last ten years.

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

The annual 2017 PharmSource 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.

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