Industrial manufacturing authorization for pharmaceuticals
Galena Pharma holds a permit for the industrial manufacture of pharmaceuticals. The permit issued by the Finnish Medicines Agency (Fimea) is numbered 007119/06.08.00.04/2016. The operating permit covers pharmaceuticals intended for humans and animals.
Manufacturing operations currently cover the complete manufacture of the following non-sterile forms of pharmaceuticals:
- Other solid forms of pharmaceuticals – powders
- tablets
Manufacturing operations currently cover the packaging of the following forms of pharmaceuticals:
- Capsules, hard and soft
The operating permit also covers physical quality control testing and importing pharmaceuticals into the EU/EEA. The certificate can be viewed on the EudraGMP database here.
Manufacturing authorisation for investigational medicinal products
Galena Pharma holds a permit for the industrial manufacture of clinical trial pharmaceuticals. The permit issued by the Finnish Medicines Agency (Fimea) is numbered 007119/06.08.00.04/2016. The operating permit covers pharmaceuticals intended for humans.
The manufacturing operations for clinical trial pharmaceuticals currently cover the manufacture of the following forms of pharmaceuticals in their entirety:
- Other solid forms of pharmaceuticals – powders
- Capsules, hard
- Tablets
- Semi-solid products – gels and creams
The operating permit also covers physical quality control testing.
The certificate can be viewed on the EudraGMP database here.