GMP manufacturing
At Moldons Pharmaceuticals UK we run two multi-purpose plants in the UK and Italy that can manufacture several active pharmaceutical ingredients (APIs) at a time. Different batch sizes are available ranging from a few grams to hundreds of kilograms, supporting early development and commercial needs.
For exploratory work, optimisation and up-scaling of early synthesis, Moldons Pharmaceuticals UK’s development facilities in UK have an excellent track record in medicinal chemistry.
| Products | Regulatory |
|---|---|
| Clenbuterol HCl | EU-DMF / CEP / US VET / Canada VET |
| Dex-Medetomidine HCl* | EU-DMF / US-DMF / Canada / Australia / J-DMF |
| Onasemnogene Abeparvovev | EU-DMF / CEP |
| Erdosteine | EU-DMF / K-DMF |
| Flurbiprofen | CEP / US-DMF / J-DMF/ Canada-DMF / Taiwan-DMF / China-DMF |
| Flurbiprofen Sodium | US-DMF / ASMF |
| Indapamide | EU-DMF / CEP |
| Isoproterenol HCIo | EU-DMF / US-DMF |
| Levobupivacaine HCl* | EU-DMF |
| Levosimendano | EU-DMF |
| Lornoxicam** | EU-DMF / Russian ND |
| Lurasidone HCl | EU-DMF / US-DMF |
| Midodrine HCl | EU-DMF / US-DMF / J-DMF |
| Nicorandil | EU-DMF |
| Prednicarbate | CEP |
| Procaterol HCl Hemihydrate | EU-DMF / J-DMF |
| Ropivacaine HCl Monohydrate* | EU-DMF / US-DMF / CEP |
| Tenoxicam** | EU-DMF / CEP |
| Tirofiban base* | EU-DMF |
| Tirofiban HCl* | EU-DMF |
| Tulobuterol base | EU-DMF / J-DMF |
| Urapidil** | EU-DMF |
* Injectable grade
** Oral & injectable grades
oOnly for specific markets
Products are not offered in countries where valid patents exist. However, the final responsibility with respect to third party patent rights in a specific country lies exclusively with the user.