Patheon Leads in New Drug Approvals

The company is an NDA leader, according to PharmSource CMO Scorecard.

Patheon announced it’s been cited by the 2017 PharmSource CMO Scorecard for capturing the most outsourced new drug approvals (NDAs) in the US; more than any other contract manufacturing organization (CMO) in 2016. The annual CMO Scorecard analyzes 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.

The accolade, said Patheon, underscores the company’s leadership position in the CMO sector and highlights the fact that Patheon supported approximately 30% of all new drug approvals on behalf of clients in 2016, and was awarded approximately 25% of all outsourced approvals in the last 10 years. Patheon was the only CMO recognized for having multiple approvals for both drug substance and drug product.

“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 over 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.”

Among the key findings, the report noted that Patheon was responsible for 17 out of 55 (30 %) of all outsourced NDA approvals in 2016, four times more than the closest competitor. Similarly, Patheon received 112 new molecular entity (NME) and non-NME NDA approvals, more than the next six leading CMOs combined (2007-2016) as well as significant awards for solid dose NME approvals, solid dose non-NME approvals and parenteral NME approvals in the last 10 years.

 

Nice Insight

Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.

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