European API makers must invest to compete with India, says Infa Group
Economies such as India and China have been viewed as low-cost alternatives to Europe and the US for the supply of active pharmaceutical ingredients (APIs), but over the past few years, pharma’s changing demands – coupled with concerns over a drop in quality standards – are seeing some customers return back West.
This is certainly the case for the Infa Group, one of many European API makers exhibiting at CPhI Worldwide in Madrid, Spain.
Daniele Cardoso, Chairman of the firm, said he has seen a number of its main clients return from Asia, and told in-Pharmatechnologist its secret to competing with its low-cost rivals: “Investing, investing ...and investing.”
An example of this is the firm’s new R&D centre, inaugurated in September at its Sifavitor site in Milan, Italy. The site will be dedicated to generic APIs with specific focus given to the respiratory area with ongoing progress on the development of indacaterol, vilanterol and umeclidinium.
“We invested more than €2m ($2.2m) and we almost doubled the local team,” Cardoso said, adding such an investment was “a pillar of our strategy of growth.”
He continued, telling us the firm services all the major generic players, and “this expansion is generated by our own strategy, not on a specific client demand.”
The site was approved by the US Food and Drug Adminstration (FDA) following an inspection in April this year. The firm’s Labochim plant was inaugurated for High Potent API (HPAPI) manufacturing earlier this year, but an FDA inspection in May resulted in a Form 483 with two minor observations.