Supply of paclitaxel will not be disrupted for Canadian patients
OTTAWA, May 9, 2014 /CNW/ - Health Canada today confirmed it has
suspended the establishment licence of Biolyse Pharma Corporation's
facility in St. Catharines, Ont., because of significant concerns with
the manufacturing process discovered during a recent inspection.
Injectable paclitaxel (6mg/ml), used in the treatment of certain lung
and breast cancers, is currently the only drug produced at that
The suspension of the establishment license means Biolyse is not
permitted to sell paclitaxel from that facility to the Canadian market
until the serious manufacturing concerns are fully addressed and the
suspension on their establishment licence is lifted.
To receive and maintain an establishment licence in Canada, a company
must comply with Good Manufacturing Practices (GMP), which help to
ensure that the drugs sold in Canada are safe, effective and of high
quality. These guidelines are applied to all companies and are widely
Health Canada has confirmed that supplies of paclitaxel are available
from another manufacturer that is licenced to produce it in Canada. The
Department is also in regular contact with the provinces and
territories regarding the supply situation. There has been no supply
disruption caused by the licence suspension.
In the short term, Health Canada is allowing the Biolyse product
currently on the market to continue to be used for treatment. However,
Health Canada cannot be assured that future supplies of paclitaxel from
Biolyse would be safe and effective for use by patients until the
serious manufacturing violations are resolved.
Patients currently being treated with paclitaxel from Biolyse should
speak to their healthcare professional if they have concerns with their
Health Canada officials continue to work with the staff at Biolyse
Pharma to resolve the issues identified during the inspection as
quickly as possible.
SOURCE: Health Canada
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