History

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, infusible emulsions and sophisticated solid formulations, e.g. Multiple Unit Pellet Systems (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. In recent years, the manufacturing license has been constantly expanded and adapted to the needs of our customers.

It also involves procurement of comparator products or clinical test products from non-EU countries. Therefore, the competent authority in Berlin has granted the wholesaler license as well as the import license for clinical supplies in accordance with § 52a and §72 AMG, respectively.

This is particularly important when the ideal comparator products available on the market are to be used for bioequivalence studies.

Based on dissolution studies conducted in accordance with CPMP/EWP/QWP/1401/98 Rev. 1/Corr ** and supplemented, if necessary, by further investigations—such as Franz Cell experiments—the most suitable batches for such studies should be identified.

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. This also includes the storage of medicinal products under forced degradation conditions as well as in climatic zones, as required by ICH and/or WHO.

In addition to our analytical service for developmental purposes, GMP-compliant analytics has been successively expanded. Starting materials, intermediate products and finished products are tested according to § 14 AMWHV in terms of conformity with the respective applicable pharmacopoeia or authorization specification.

The same also applies to medicinal products to be imported into the European Union from non-EU countries. The so-called “re-test” and market release in accordance with §§14, 16 AMWHV, EU GMP Annex 16, 21, withdrawal/storage of retention sample in accordance with § 18 AMWHV, EU GMP Annex 19 are core competences of our service spectrum.