Contract development & manufacturer
Unimedic has many years’ experience of the development and production of pharmaceuticals and has accumulated extensive knowledge in the area of liquid pharmaceutical formulations, both sterile and non-sterile. Thanks to our scientific expertise, we are the partner of choice for the development, formulation, production and quality assurance of pharmaceuticals and non-prescription health care products similar to prescription drugs. We work with both large and small companies. Unimedic’s collaboration with academies, the industry and the health care sector is well-established and is an extra guarantee for quality, know-how and innovation.
Our widespread and highly qualified network enables us to carry out widely different assignments with a great deal of flexibility. We can undertake everything from short-term, one-off asssignments to long-term, wide-ranging projects which include every aspect of development work – from idea to a final product in large-scale production. We have expertise in, and experience of, the development of both new and existing products.
In our modern laboratories, we perform a large number of chemical and microbiological analyses. We analyse active raw materials (API), excipients, WFI and finished products. We use methods described in the Swedish pharmacopoeia as well as procedures we have developed ourselves.
We develop sterile and non-sterile pharmaceutical solutions. The product development services we can offer include formulation development from laboratory scale batches up to full scale batches, development and validation of chemical and microbiological analytical methods and stability studies at ICH conditions. We can also support artwork changes and changes in primary packaging materials.
Manufacturing is carried out on modern production lines, ensuring that it is efficient and safe, and that it fulfils EU-GMP requirements. We can offer the following manufacturing alternatives:
- Sterile injection ampoules / 1-10 ml
- Sterile injection bottles (phials) / 10-100 ml
- Products containing alcohol, explosion proof / 25-5000 ml
- Mixtures and soluble products / 25-5000 ml
- Nasal Spray Formulation
Our manufacturing plant is extremely flexible and can be adapted to produce batches of up to 20 000 litres. Our sterile production department can handle batches of up to 600 litres. For non-sterile products, we can offer batches of up to 20 000 litres.
We perform stability studies in accordance with ICH guidelines. We store samples in climatic test chambers and keep the temperature and atmospheric humidity in these chambers under constant surveillance. We can help with the setup and planning of stability studies, as well as with the compilation of documentation and verification of content accuracy.