News: Methods – Authorizations – Publications

Subvisible particles

  • METHOD 1, Light Obscuration Particle Count Test
  • METHOD 2, Microscopic Particle Count Test; Combination of required conditions as claimed in Ph.Eur. 2.9.19
    The method is performed by a microscope with motorized stage and camara system (GMP-qualified).

Parenteral Nutrition

  • Already developed lipid emulsion with granted marketing authorization
  • Based on experience, stability testing of all in one-systems and three-chamber bags
  • Justification of specification

Manufacturing License for Drilling and Stuffing of Tablets used in Clinical Studies

  • Procurement of Reference Medicinal Products
  • Manufacturing under GMP-conditions for use in Magnetic Marker Monitoring (MMM) – studies
  • Analytical support regarding dissolution testing, assay and on-going storage during the time-frame of clinical study
  • QP-release for clinical studies


PDF-pages of our Manufacturing and Import License

Import License_engl

Manufacturing license_engl