Replies to post #8938 on Intellipharmaceutics International Inc. (IPCI)

[doogdilinger]

Just the second time that IPCI's facility has passed FDA inspection is all...but another feather in their cap nonetheless>>>

Intellipharmaceutics Reports that the FDA has Given Its Toronto Manufacturing Facility an “Acceptable” Classification



Toronto, Ontario, October 27, 2014 – Intellipharmaceutics International Inc. (NASDAQ:IPCI) (TSX:I), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that the United States Food and Drug Administration (“FDA”) has provided the Company with written notification that its Toronto, Canada manufacturing facility has received an “acceptable” classification.



The Company’s Toronto premises comprise 25,000 sq. ft., including management, R&D, manufacturing, quality control and drug product release testing components. The inspection of the manufacturing facility was performed in May 2014. Such inspections are carried out on a regular basis by the FDA, and an “acceptable” classification is necessary to permit the Company to be in a position to receive final approvals for Abbreviated New Drug Applications (“ANDAs”) and for New Drug Applications (“NDAs”), and to permit manufacturing of drug products intended for commercial sales in the United States after any such approvals. No assurance can be given as to whether or when the FDA will approve any Intellipharmaceutics application for its product candidates, that our facility will continue to satisfy the requirements of the FDA, or that any of our product candidates will ever be successfully commercialized.



This marks the second time that the facility has passed an FDA inspection. In a previous audit carried out by the FDA in July 2011, the facility was also classified as acceptable.



“We are pleased and proud to have again achieved an “acceptable” classification for our facility,” stated Dr. Isa Odidi, CEO and co-Chief Scientific Officer. “The FDA facility audit process is rigorous and exacting, and we believe the successful classification is an indication that our unwavering commitment to current good manufacturing practices (cGMP) is well worth the effort.”