Althea Technologies, a contract development and manufacturing firm, has obtained license from the US Food and Drug administration (FDA) to manufacture and package a commercial parenteral product for the US market.
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The FDA’s decision follows a Pre-Approval Inspection (PAI) which was done in April 2011 by the US regulators.
The company expects to do the filling and packaging of the product in its San Diego-based California manufacturing plant.
Althea president Rick Hancock said they anticipate working with their clients to bring several other products to commercialization over the coming months.
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