Hovione's Portuguese API plant passes FDA inspection

Published: 2-Oct-2009
Ingredients

Hovione\'s active pharmaceutical ingredient (API) plant in Loures, Portugal has passed a pre-approval inspection by the US Food & Drug Administration (FDA).


Hovione's active pharmaceutical ingredient (API) plant in Loures, Portugal has passed a pre-approval inspection by the US Food & Drug Administration (FDA).

The inspection covered five ANDAs and one NDA and focused on Hovione's documentation systems, especially on how the company records and manages OOS, deviations, change control, batch production records and analytical procedures. The inspection focused on looking for inconsistencies in procedures.

The Loures site has had 10 inspections since 1982. It employs 500 people and produces generic products, as well as APIs and bulk formulated products for clinical trials and for commercial sale.

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