In the beginning of last December two inspectors from the American health authorities FDA (Food and Drug Administration) conducted a pre-approval inspection at the premises of the Binzen Glatt Technology Centre. They investigated intensely the general localities, the pharmaceutical production area and the analytical laboratories.
Their special inspection focus was on the GMP-conform documentation.

The inspection resulted in four minor findings only, such entitling us to now call the Binzen Technology Centre “FDA approved”.
For us, this presents a major milestone in the relatively young history of our Technology Centre, as we now better qualify as a competent partner not only for the American pharmaceutical companies but for all companies interested in the US market. Moreover, also for domestic markets a manufacturing place qualified by the FDA always recommends itself as a top address for the outsourcing of

- pharmaceutical development
- manufacturing of clinical samples
- product launch supply
- contract manufacturing

Since mid 2006 we are furthermore manufacturing a pharmaceutical product for the US market which has been developed in a co-operation between Glatt Air Techniques in Ramsey and our Technology Centre in Binzen.

For this specific product we are applying one of our innovative and proprietary pelletising technologies. 

The FDA inspectors with the Glatt-team