Hovione today announced that in the past 8 months the Company has had a large number of GMP inspections by the major Medicines’ Agencies.
The Japanese PMDA inspected our sites in China and Portugal. The US FDA inspected our sites 3 times: Loures twice and New Jersey once. The Portuguese authorities also performed an inspection in April. In the last week of April FDA inspected simultaneously both New Jersey and Loures, in both cases no Form 483 was issued. The PMDA inspections have also been closed successfully.
On the outcome of the PAI in Loures Luisa Paulo, Director of Compliance at Hovione, commented: “This was the best pre-approval inspection ever by FDA. The investigators were very experienced and very well prepared; they had studied the file in great detail. This was a Quality by Design submission and a key element of it was a continuous process – so the discussions were really interesting. We definitely broke new ground.”
The large number of inspections reflects the constant flow of submissions that Hovione clients make. Innovator drugs, generics, devices all make use of Hovione APIs or of its technologies that focus on particle properties in high performing formulations. “Our clients are thrilled. Successful outcomes at inspections is not an unusual event at Hovione, but to continue with this kind of stellar record in the current climate is something that makes us all really proud “ said Guy Villax, Hovione’s CEO.
About Hovione
Hovione is an international company with over 50 years’ experience in Active Pharmaceutical Ingredient development and compliant manufacture. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers, in the most regulated markets. The company also offers integrated API, particle design and formulation development and manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.
For more information about Hovione, please visit the Hovione site at www.hovione.com or contact Corporate Communications, Isabel Pina, +351 91 7507 462 or + 351 21 982 9362, e-mail: ipina@hovione.com.