Patheon ranked as top contract development and manufacturing organisation
Ranking based on independent research detailing NDA‐ and BLA‐approved products outsourced to contract manufacturers*
Patheon, a global provider of drug development and manufacturing services to the international pharmaceutical industry, has been ranked as a top global contract development and manufacturing organisation.
PharmSource, a respected independent pharmaceutical research organisation, recently published a study looking at the number of FDA new drug approvals (NDAs and BLAs) which were outsourced by sponsor companies and subsequently launched.
The study found that Patheon had the highest number of new drugs overall, and by far the highest number of solid dose drugs over the past four and a half years. The study was conducted independently by PharmSource and was not commissioned by Patheon.
Wes Wheeler, Patheon’s ceo and president, said: ‘The results of this research again position Patheon as a leading formulation development company, capable of taking new drugs from the lab all the way to full commercialisation. We continue to make strategic investments in pharmaceutical development, which now boasts nearly 600 scientists in eight development centres.
‘We will soon have our French development centre ready for use, bringing us to nine development centers. Six of these development centres are attached to our commercial scale manufacturing facilities, which allow us to offer a unique, broad‐based ‘molecule to market’ service to our customers.
‘We are proud to be working with 19 of the top 20 pharmaceutical companies, 17 of the top 20 speciality pharmaceutical companies and six of the top 10 biotechnology companies. We will continue to invest in our facilities and maintain the highest degree of regulatory compliance as we enter a new age of outsourcing.’
Research Methodology
The PharmSource research was based on data including all therapeutics approved by the FDA from 1 January 2005 to 30 June 2010 that were outsourced to CMOs. Exactly 200, or 42% of the 475 approvals were outsourced. Of those 200, PharmSource was able to successfully identify the contract dose manufacturer for 185 of them.
The market was segmented into four dosage form categories: solid, semisolid/liquid, injectables, and speciality delivery. In total, 72 different CMOs had at least one of the 200 outsourced FDA approvals granted during the period. The top 12 dose CMOs accounted for 105 of those approvals and Patheon received 20 of the approved products for development.
*JULY 2010 “Top Dose CMOs by Number of NDA and BLA Approvals,” PharmSource.