The Navarra-based contract manufacturing organisation (CMO) told Outsourcing-pharma.com about the state of play in Spain today during a discussion of its recent receipt of extended manufacturing approvals from national regulators, more of which later.
Business development manager Manueal Leal told us that: “The situation of the Spanish pharma industry is dire, due to price cuts approved by the Spanish Government and other cost-cutting initiatives that have clearly impacted our clients’ top and bottom lines.”
And, while forecasts for 2014 are more encouraging, the current situation and its impact on local customers has prompted the CMO to look outside Spain for business.
“For us, as for many Spanish companies, the internationalization of our business is the only way forward. In 2013 almost 40% of our revenues came from abroad.”
He added that: “In our case, the specialization in high-potency drugs and use of technologies such as spray drying, have definitively helped us gain new business. We are really delighted by the amount and quality of new business we have generated all over Europe in the last years.”
That said IDIFarma does continue to work with Spanish customers that have been “dynamic and smart enough to dodge the bad economic situation” says Leal citing Barcelona-based Oryzon, on whose behest the CMO recently gained new approvals, as an example.
“Our decision to seek extended GMP authorization was motivated by a specific project for our client ORYZON, which required us to manufacture a novel and highly potent drug for a first-in-human clinical trial.
The new approval from the Spanish Medicines Agency (AEMPS) means IDIFarma can make powders for oral use for clinical trials, as well as tablets and hard capsules.
Leal said that: “This new authorization is definitely aligned with IDIFARMA’s mission to be a top choice for any pharma company requiring specialized clinical manufacturing services.”