Registration Dossiers
Labochem SA is offering CTD registration dossiers either owned developments or through contract partners.
We have completed own developments and offering relevant CTDs for registration in EU and non-EU countries.
| ACTIVE INGREDIENTS | DOSAGE FORM | PACKAGE | DOSSIER STATUS | BE AVAILABLE | MA Reference |
| GASTROINTESTINALS / ANTI-ULCERANTS | |||||
| Omeprazole caps | g.r. caps 20 mg | bt x 14 caps | EU CTD | √ | EU Granted |
| g.r. caps 40 mg | bt x 14 caps | EU CTD | √ | EU Granted | |
| bt x 28 caps | |||||
| ANTI-INSTAMINIC | |||||
| Dimetindene Maleate Oral Drops | 20 ml (1mg/ml) | EU CTD | DCP Q1 2021 | ||
| 50 ml (1mg/ml) | EU CTD | DCP Q1 2021 | |||
| Dimetindene Maleate Gel | 30 g (1mg/g) | EU CTD | CTD Q2 2021 | ||
| 50 g (1mg/g) | EU CTD | CTD Q2 2021 | |||
| CVS (CARDIOVASCULAR SYSTEM) | |||||
| Candesartan | tabs 4 mg | bt x 14 tabs | EU CTD | √ | EU Granted |
| bt x 28 tabs | |||||
| tabs 8 mg | bt x 14 tabs | EU CTD | √ | EU Granted | |
| bt x 28 tabs | |||||
| Tabs 16 mg | bt x 14 tabs | EU CTD | √ | EU Granted | |
| bt x 28 tabs | |||||
| tabs 32 mg | bt x 14 tabs | EU CTD | √ | EU Granted | |
| bt x 28 tabs | |||||
Please do not hesitate to ask, upon your request we will send you list of all available dossiers.