July 20, 2009 Brevard, NC USA:
PharmAgra Labs, Inc. today announced a successful FDA inspection which was completed on July 1, 2009. The Company’s cGMP manufacturing facilities were the subject of the audit which included a pre-approval inspection and a general quality systems inspection. No form 483 observations were issued.
This is the first FDA Pre-Approval Inspection of PharmAgra’s Facility. “The inspection was thorough and we are very pleased with the outcome” said Roger Frisbee, Co-President of PharmAgra Labs. “PharmAgra is dedicated to maintaining compliance with FDA requirements and operating a clean, well-organized facility”
“The ability to provide cGMP synthesis provides an excellent complement to our discovery support/process chemistry services” according to Peter Newsome, Co-President of PharmAgra Labs. “We now have the ability to take clients from initial discovery, through development and into the clinic.”
About PharmAgra Labs
PharmAgra Labs, Inc. is a privately held company that for over ten years has been providing contract R&D in organic and medicinal chemistry. The company also has a facility for cGMP production of Active Pharmaceutical Ingredients for use in Clinical Trials. The company owned, fully equipped facility is located in Brevard, NC. Please visit our website at www.pharmagra.com.