Successful FDA inspection at Italian site

16.02.10

Haupt Pharma, one of Europe's leading contract developers and manufacturers, has undergone a successful inspection by the US Food and Drug Administration (FDA) at its Italian site without any FDA-483 observation being issued.

Haupt Pharma Latina has extensive know-how in contract manufacturing, packaging and the quality control of conventional dosage forms, as well as specific expertise in beta-lactam and veterinary products - both sterile and non-sterile.
“We have reached an important milestone by successfully passing the FDA inspection in Latina, which confirms the high standards of good manufacturing practice at our company," said Hans-Christian Semmler, CEO.
The inspection covered all areas of the organisation and systems involved in the production of sterile penicillin products.

After the seven-day audit, the site is now approved to produce two sterile penicillin antibiotics for human health for the US market.
This first pre-approval inspection at the Latina site was triggered by the submission of two pre-approval supplements for sterile penicillin products from one of Haupt Pharma’s customers.

The outcome of the assessment highlights the expertise and commitment of the site’s team that contributed to this outstanding result.

Haupt Pharma is now able to deliver from five FDA-inspected sites in Italy and Germany high-quality products for the demanding and highly regulated US market.

For further information about our Italien site please click here:
Haupt Pharma Latina