GMP manufacturing

In Paderno Dugnano, Recipharm runs a multi-purpose plant which can manufacture several API products at a time, handling high pressure, high temperature (up to 150 degrees Celsius) and low temperature (down to –80 degrees Celsius) reactions. Different batch sizes are available ranging from 20L to 6000L, supporting early development and commercial needs. General APIs and some hormones are manufactured.

For exploratory work, optimisation and up-scaling of early syntheses, Recipharm’s development facility in Uppsala has an excellent track record in medicinal chemistry.

Recipharm also runs a dedicated beta-lactam plant for the lyophilisation of bulk API in Lainate, Italy.

Available APIs from the Paderno Dugnano facility
Products Regulatory
Blonanserin   EU-DMF / J-DMF
Clenbuterol HCl EU-DMF / CoS
Dex-Medetomidine HCl** EU-DMF / US-DMF
Erdosteine EU-DMF / K-DMF
Glimepiride EU-DMF / CoS
Indapamide EU-DMF / CoS
Levobupivacaine HCl** EU-DMF
Lornoxicam* EU-DMF
Lurasidone HCl US-DMF
Midodrine HCl EU-DMF / US-DMF / J-DMF
Nicorandil EU-DMF
Prednicarbate EU-DMF – CoS
Procaterol HCl Hemihydrate EU-DMF / J-DMF
Ropivacaine HCl Monohydrate** EU-DMF / CoS
Tenoxicam* EU-DMF / CoS / J-DMF
Tirofiban base** EU-DMF
Tirofiban HCl** EU-DMF
Tulobuterol EU-DMF / US-DMF / J-DMF
Urapidil* EU-DMF

* Oral & injectable grades        
** Injectable grade

Products are not offered in countries where valid patents exist. The final responsibility with respect to third party patent rights in a specific country lies exclusively with the user.

Products under development are supplied for R&D purposes only and in compliance with Italian law and as permitted under 35 USC 271.