The US Food and Drug Administration (FDA) has granted 'acceptable' status to Intellipharmaceutics International's Toronto-based oral solid dosage forms manufacturing facility, following the completion of a cGMP and pre-approval inspection process.
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Earlier, the Toronto manufacturing plant was inspected and approved by Health Canada.
The manufacturing facility manufactures oral solid dosage forms including controlled-release and targeted-release tablets, spheres, beads and capsules.
Intellipharmaceutics CEO Isa Odidi said the move is a major milestone for the company and reflects the quality of their facilities and manufacturing processes.
"It demonstrates the progress we are making towards the completion of our manufacturing infrastructure in anticipation of approval and commercialization of our products in the US," Odidi added.
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