Italy
Origgio/Isso, Italy
cGMP center of excellence

Our Origgio and Isso sites form the heart of Archimica’s cGMP capability and have been manufacturing APIs since the 1970s. These sites are the center of our global regulatory compliance effort and have been the subject of continuing investment to maintain state-of-the-art conditions.

Our Italian sites excel in multipurpose facilities permitting flexible production of bulk APIs and late-stage intermediates. The sites in Origgio and Isso comprise cGMP production facilities, pilot plants, R&D, QC, and microbiology laboratories. They fully comply with ICH Q7A regulations and are FDA-inspected. Both locations are authorized by the Italian Ministry of Health for the production of human and veterinary drugs.

The Origgio site has been regularly inspected by the FDA since 1975, with the last inspection in October 2007. The Isso site was successfully inspected in March 2007. The last Italian Ministry of Health inspection at the Origgio plant was carried out in April 2003, and at Isso in April 2005.

If you need directions to our Origgio site click here.
If you need directions to our Isso site click here.
 
Specialized strengths
APIs, antivirals, antihypertensives, quinolones, nucleosides (including veterinary)

Specialized technologies
Cryogenics (to -80°C), high & low pressure hydrogenation (80 bar), lithium, magnesium oxidations (with hydrogen peroxide), organometallics, phosgenation (triphosgene)
Specialized reagents &
solvents handled

Chlorinated solvents, diazo acetic acid esters, hydrogen, Li-selectride, lithium, magnesium, sodium borohydride, triphosgene