New Products at Hovione, 6 Inspections in 8 Months
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
inspected our sites 3 times: Loures twice and
authorities also performed an inspection in April. In the last week of April
FDA inspected simultaneously both
Form 483 was issued. The PMDA inspections have also been closed successfully.
On the outcome of the PAI in
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.,
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
For more information about Hovione, please visit the Hovione site at
http://www.hovione.com or contact Corporate Communications,
+351-91-7507-462 or +351-21-982-9362, e-mail: email@example.com.