Aschimfarma: an Italian leadership in the global pharmaceutical-chemical market

ASCHIMFARMA, a branch of the Italian Chemical Industry Federation (FEDERCHIMICA), is the Association of producers of pharmaceutical fine chemicals. These companies produce organic chemical substances obtained through high technological industrial processes, both in the development and production phases.

A single figure is enough to indicate how successful the whole Italian producers of active pharmaceutical ingredients and intermediates are proving in the world markets: a good 85% of their total turnover, estimated to 3.4 billion Euro in 2014, is accounted for by export.

One result of which Italian firms are particularly proud is that they are the main suppliers of bulk pharmaceutical chemicals to the US market. The Italian producers are open to inspection by the FDA, and this implies a specific obligation to demonstrate that employees are both highly qualified and specifically and continuously trained.  The quality of output is guaranteed by strictly applying Good Manufacturing Practices, which mostly draw the companies’ attention and elicit their commitment. They are also subject to inspection and authorization by AIFA – Italian Medicines Agency.  A fundamentally important development is the presence of Italian manufacturers at exhibitions dedicated to the bulk pharmaceuticals industry.
Italian manufacturers pursue the harmonization of inspection practices at the highest level as a guarantee for customers and a safeguarding of public health. Related to this point Aschimfarma over the last years has strongly asked that the competent Authorities would inspect the extra-EU manufacturers in order to verify the compliance with the European GMPs and release GMP Certificates to allow the inspected sites to export towards European Union.

The incidence of Research & Development on the total turnover of the sector may be valued at approximately 3%. R & D is aimed mainly at process optimization, in relation, above all, to the high cost of the investments required to identify and prepare new pharmaceutically effective APIs. The efforts made in Research & Development have enabled the Italian industry in this sector to “consolidate” and even “improve” its position in time, pursuing diversified process technologies that make it possible to:

·      continue to maintain the leading position held traditionally by the Italian industry on the generic medicine market;

·      increase the proportion of sales represented by “custom synthesis”, to maintain a high level of profitability and compensate for the difficulties in the generic medicine sector.

All the initiatives of Aschimfarma aim to allow member firms to fight on equal terms with their international competitors. They would then be competing on the continually sustained quality of their output, rather than solely on price, so often the case with products coming from developing countries.


Italian export of active pharmaceutical ingredients and intermediates broken down by major geographical areas (%values, export=85% total turnover, 2013)


 Grafico dati settore


 Andamento del fatturato italiano di principi attivi e intermedi farmaceutici
(valori correnti, miliardi di Euro e di USD)           

Fatturato Italia