Haupt Pharma has successfully passed an inspection by the US Food and Drug Administration (FDA) at its site in Regensburg, Germany.
Haupt Pharma Amareg completed the audit for the four inspected solid and semi-solid, high-potent products, two of which were oncological products without receiving an FDA form 483. The inspection covered the full service of these products and included manufacturing and packaging, as well as development and analytics.
Haupt Pharma Amareg has extensive know-how in the contract manufacturing of various dosage forms. A core competence is the production of solid dosage forms with highly active substances. 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 result once again confirms the high quality standards within the group," said Dr Karl Heinz Brücher, chief operating officer of Haupt Pharma.
"The outstanding commitment of the entire team in Regensburg has contributed to this positive result."
With six FDA-inspected sites in Germany and Italy, Haupt Pharma is able to deliver high-quality products for the demanding, highly regulated US market.