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Haupt Pharma Completes FDA inspection

Haupt site cleared to produce sterile penicillins for U.S. market

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Haupt Pharma has completed a successful inspection by FDA at its site in Italy. The inspection covered all areas of the organization and systems involved in the production of sterile penicillin products. Following the seven-day audit, the site is now approved to produce two sterile penicillin antibiotics for the U.S. market.

“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, chief executive officer.

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’s customers.

The company is now able to deliver from five FDA-inspected sites in Italy and Germany for the U.S. market.

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