EMA clamps down on drugs
February 20, 2012
THE European Medicines Agency
(EMA) has released its final
recommendations for 12 medicines
manufactured by Ben Venue
Laboratories- which at present has
suspended manufacturing at its
Bedford Ohio facility (PD 12 Jan).
Ben Venue (a wing of Boehringer
Ingelheim), suspended operations
at its Ohio facility in November last
year after a joint inspection by the
US Food and Drug Administration
and the EMA which found
contamination and quality
management issues, and that the
facility’s equipment was overdue
for maintenance and
requalification.
This month, the EMA’s
Committee for Medicinal Products
for Human Use (CHMP) has given
final recommendations for 12 out
of 14 centrally authorised
medicines manufactured at the
Bedford Ohio site: Angiox, Busilvex,
Vidaza, Vistide, Velcade, Ecalta
diluent, Soliris, Cayston, Luminity,
Mepact, Torisel and Vibativ.
Last month the European
regulatory network issued a
restricted Good Manufacturing
Practice Certificate to Ben Venue in
order to stop the EU supply of its
non-essential medicines, while
allowing the continued supply of
essential drugs.
In addition, Ben Venue has been
removed as the manufacturing site
from the marketing authorisation
of Vistide and Cayston, whilst the
CHMP has now asked marketing
authorisation holders to remove
Ben Venue’s manufacturing site for
all other medicines.
The CHMP also recommended
the suspension of marketing
authorisations for two drugs,
Vibativ and Luminity (which are
not marketed in the EU), as the
pair have no alternative
manufacturer or formula available,
whilst for the remaining 10
medicines, it recommended
maintaining the marketing
authorisations as alternative
suppliers/formulations are available
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