| Pharmazeutische und chemische Entwicklungsgesellschaft
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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 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.
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