MonoSolRx Announces Successful Manufacturing Facility Audit For Oral Film Drug Productio
作者: 整理时间:2005-10-27
10/26/2005
Portage, IN -- MonoSolRx announced that it has received a successful audit report for the manufacture of pharmaceuticals under the Australian Code of GMP of Medicinal Products (2002), from the Australian Therapeutic Goods Administration (the "TGA"). The audit report followed a visit to MonoSolRx's Portage based manufacturing facility, built to Class 100,000 standards.
MonoSolRx's Vice President for Pharmaceutical Development, Dr. Pradeep Sanghvi commented: "The successful audit result from the TGA speaks very well for our quality systems and follows on the heels of several successful big pharma audits. We have worked hard to deploy traditionally rooted, rigorous quality systems around our innovative film delivery system. This audit also speaks to our ability to supply product into various markets outside of the United States, including Europe and Asia."
MonoSolRx's President and Chief Executive Officer, P. Scott Bening observed: "Today's announcement signals the strength of our quality systems. Meeting and exceeding international regulatory requirements is a key component of our quality mandate."
SOURCE: MonoSolRx LLC
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