Haupt Pharma, one of the leading European companies for pharmaceutical contract development and manufacturing, has successfully passed inspections by the US Food and Drug Administration (FDA) at four sites in Germany during the first half of 2012.
Now six facilities of the Haupt Pharma Group have received permission to manufacture drugs for the US market. The FDA audits examined whether manufacturing and quality control meets US regulations, which diverge from those in Europe.
"These successful audits help the Group to come much closer to its strategic goal of further expanding its presence in the US market," explains Haupt Pharma COO, Dr Karl Heinz Brücher. "This result is an extremely positive signal to our customers and the market, as it reflects both the exceptional performance and the high level of quality of our sites."
The United States is the largest pharmaceutical market worldwide. Further growth is also expected due to the passage of US healthcare reform. Furthermore, a large number of patents will expire worldwide over the next few years. As a result, brand-name products will increasingly be replaced by generics.
These developments are positive for contract manufacturers, such as Haupt Pharma, because – unlike companies specialising in originator medicinal products – generics companies increasingly outsource their production to contract manufacturers.