Manufacturing Authorisation

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.