FDA approves Althea's PAI to manufacture commercial parenteral product

Jun 28 2011

Althea Technologies, Inc. announced today that following a comprehensive FDA Pre-Approval Inspection (PAI) in April 2011, it has received a license to manufacture and package a commercial parenteral product for the US market.  The product will be filled and packaged at the company's new, state-of-the-art commercial manufacturing facility located in San Diego, California.  This facility, the third on Althea's campus, was constructed to accommodate the increased demand the company has experienced in both its drug product and biologics manufacturing business units. To support this growth, the company has also expanded its analytical development, stability testing and formulation development capabilities for larger clinical and commercial projects.  

"We are very pleased with the successful outcome of our initial PAI and anticipate working with our clients to bring several other products to commercialization over the coming months," stated Rick Hancock, President of Althea Technologies.  "Our entire team feels very gratified to have achieved this major milestone.  This accomplishment is the result of thoughtful and diligent investment in expanding our quality systems, facilities and operational capabilities in a climate that has been challenging for many companies in our industry."

In the past 12 months, Althea has installed and validated a fully-automated, INOVA H3-5 syringe filling line that can accommodate high viscosity and shear sensitive products.  This line can accommodate a wide variety of glass or plastic syringes and cartridges in batch sizes exceeding 100,000 units and is a critical component of the company's expansion in commercial manufacturing.