Draxis gets two thumbs up in inspection - Biologics Delivery

Draxis gets two thumbs up in inspection
5/23/2007
By Katrina Megget
DrugResearcher.com
This news is provided by:
In-PharmaTechnologist.com
Canada-based Draxis Health has passed a US Food and Drug Administration (FDA) inspection with flying colours after contracting out its manufacturing services to two new clients.
The Quebec manufacturing facilities of Draxis Pharma, the contract manufacturing division of Draxis Health, has retained its classification as acceptable following the extensive inspection of all six production and quality systems in January.
The inspection was initiated by two new contracts and form part of each client's FDA regulatory application to authorize Draxis to manufacture products for distribution in the US.
The clients could not be disclosed but the products require a sterile lyophilization (freeze-drying) production facility.
Lyophilization is a technologically demanding process where all the moisture is removed from the product to extend its shelf life. It is used predominantly in biologic drugs such as vaccines, hormones and antibodies.
There was also no Form 483 Inspectional Observations issued during the FDA evaluation. These are commonly issued with suggestions of possible improvements.
"From our perspective it's a benefit we can offer to our customers. Our systems are up to scratch," Draxis executive director for investor relations Jerry Ormiston told US-PharmaTechnologist.com.
"It's not a change in status it's a reconfirmation of compliance," he said.
Draxis Health president and chief executive Dr Martin Barkin said the positive results reflected a "strong commitment to providing the highest level of quality and regulatory compliance for our clients and their products".
"By continually meeting the increasingly stringent standards established by the FDA and other international regulators, we have been able to grow our contract manufacturing business by more than 300 per cent over the past five years.
"We are focussed on maintaining and exceeding good manufacturing practices to further improve our record of regulatory excellence as we increase our offering of value-added lyophilized and sterile production services to the pharmaceutical and biotechnology communities," he said.
Draxis Pharma expanded its lyophilization capacity in its Montreal facility in late 2005 with the addition of a second, in-line integrated lyophilization unit. Additional sterile product manufacturing capabilities allow the company to produce injectable liquids in vials and ampoules as well as sterile ophthalmic products, creams and ointments.
Earlier this year fellow Canadian contract manufacturer Dalton Pharma received a compliant rating from Health Canada - the Canadian equivalent of the FDA - for its plant located in Toronto. At the time the company said it would be expanding its lyophilisation capabilities in the near future.
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