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Doppel waiting for FDA approval in 2019

Pharmaceutical manufacturing is very important to Italy as a country and, according to a recent survey performed by the CDMO Association, Italy is in fact the leading country within Europe for pharmaceutical outsourcing. Germany comes in second place with France in third position. As such, Italy plays a critical role within the European pharmaceutical manufacturing industry. This leading position is the result of a strong base of expertise and culture around pharmaceutical manufacturing that has developed over several decades and today the base of pharmaceutical manufacturing capital is very high; the average plant in Italy is more sophisticated than in many other European countries and there are a number of truly state of the art facilities in the country. While Italy’s position and leadership in this regard has not always been well known; those working in the pharmaceutical industry today are generally aware that Italy is a center of excellence for pharmaceutical manufacturing.

Doppel has played a critical role in developing the industry’s culture, as for many years it was the leading Italian owned CDMO in the country. Indirectly, Doppel contributes significantly to Italy’s pharmaceutical exports via our clients, as nearly 40 percent of our EUR 90 (USD 102.6) million revenues are generated by brands that are eventually sold outside of Italy. Moreover, Doppel has a presence via our clients in markets not just across all of Europe, but worldwide in countries like Russia, China, South Korea and Brazil. For the time being we are not present in the US, but three projects are underway to get FDA approval for certain production lines; we expect to have the FDA approval in early beginning of 2019 for the Rozzano site.

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