Haupt Pharma, one of Europe’s leading contract developers and manufacturers, has successfully passed an inspection by the US Food and Drug Administration (FDA) at its site in Regensburg, Germany, without any FDA-483 observation being issued.
Haupt Pharma Amareg has extensive know-how in contract manufacturing, packaging and quality control in many common dosage forms. The production of solid dosage forms with highly active substances represents a core competence of the company. In this segment, the site is also a successful development partner with many international companies.
“The management board congratulates Haupt Pharma Amareg on its successful completion of the FDA inspection. This is a fundamental element in the continuing efforts to further increase the value and appeal of this site,” said Dr Karl Heinz Brücher, chief operating officer of Haupt Pharma.
This pre-approval inspection by the FDA was triggered by a veterinary medicinal product with a highly potent API that is to be launched on to the American market.
The result of this approval procedure highlights the expertise and commitment of the site’s team in Regensburg that contributed to this outstanding result.
With six FDA-inspected sites in Germany and Italy, Haupt Pharma is now able to deliver high-quality products for the demanding, highly regulated US market.