Phebra plant GMP licence
May 14, 2013
THE TGA yesterday granted a
formal licence to the new Sydney-based
sterile manufacturing
plant operated by Australian
pharmaceutical firm Phebra.
Phebra ceo Mal Eutick said it was
a “great day for the company,”
which has worked on the project
for the last three years.
The move follows stringent
assessments of the Lane Cove
plant including a series of
product validations, and confirms
Phebra’s compliance with Good
Manufacturing Practice guidelines.
“The plant is testament to
Phebra’s investment in the future of
the local manufacturing industry,”
Eutick said.
He said the new facility would
allow the company to significantly
boost its research and production
capability, with products to be
made there including emergency
injectables, antidotes and other
small volume injections.
Eutick added that Phebra would
expand its capability to conduct
“all-important development
programs now and into the future,
providing skills development
and employment for Australian
scientists and medical researchers”.
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