In 1995, Formula GmbH was founded as a highly innovative company focussing on the development of medicinal products. Today, the development of medicinal products is a core business segment of Formula GmbH with the objectives of formulation of solid, semi-solid, liquid and injectable medicinal products. This also includes the development of lyophilizates, liposomes and formulations based on Multiple Unit Pellet System (MUPS).
In 2005, Formula GmbH was granted a manufacturing license for manufacturing clinical supplies regarding packaging, labelling, blinding, testing and release of solid, semi-solid and liquid formulations for non-sterile products.
It also involves procurement of comparator products or clinical test products from non-EU countries. Therefore, Formula GmbH was granted an import licence in accordance with §72 AMG.
Galenical development is always successful if analytical development and validation of analytical methods as well as stability testing are run in parallel. Therefore, our GMP-lab is instrumentally equipped to provide the required analytical services.
In addition to our analytical service for developmental purposes, starting material, intermediate products and finished goods will be tested for quality conformance in accordance to §14 AMWHV. The same applies to analytical testing of medicinal products imported from non-EU countries. Therefore, final release (so called EU-release executed in accordance with §16 AMWHV) of medicinal products is also within the scope of service.