08.12.11
Pillar5 Pharma Inc. has successfully passed a cGMP and pre-approval inspection (PAI) for an NDA by the FDA to manufacture a solid dose product for a client. A full inspection was performed of the quality, facility and equipment, materials, laboratory, production, packaging and labeling systems, with no 483 observations.
“I am very pleased that Pillar5’s high quality standards and expertise were reflected in the outcome of this inspection,” said John Carkner, president and chief executive officer of Pillar5. “This is a significant milestone for our client partnership and brings this important product one step closer to market.”
“I am very pleased that Pillar5’s high quality standards and expertise were reflected in the outcome of this inspection,” said John Carkner, president and chief executive officer of Pillar5. “This is a significant milestone for our client partnership and brings this important product one step closer to market.”