Intellipharmaceutics Manufacturing Facility Passes Pre-Approval Inspection Print E-mail
By Staff and Wire Reports   
Tuesday, 15 November 2011 08:01
Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I), today announced that its Toronto-based oral solid dosage forms manufacturing facility has completed a cGMP and pre-approval inspection process by FDA regulators and has been granted "acceptable" status under the Agency's strict regulatory guidelines.

Two weeks ago, we told readers that the company had reached a key milestone as an even bigger one approaches- that of their first FDA approval.  The Canadian biotech has six big ticket ANDAs being reviewed by the FDA for approval, with reported sales by others for branded and generic versions of these products being approximately $6.6 billion for the 12 months ended September 2011.

Now, the company has announced that U.S. regulators have checked off after their Toronto manufacturing facility was previously inspected and approved by the Canadian regulatory authorities, Health Canada.

"We are extremely pleased and proud of the acceptable regulatory status issued by the FDA regarding our manufacturing facility," stated Dr. Isa Odidi, CEO of Intellipharmaceutics. "Passing this pre-approval inspection is a key milestone for Intellipharmaceutics. This positive FDA inspection result is a true reflection of the quality of our 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 U.S. marketplace."

The company takes investors along a less risky road as they develop both ANDA product candidates and new drugs through the New Drug Application (NDA) 505(b)(2) regulatory pathway. And while no assurance can be given as to whether or when the FDA will approve any Intellipharmaceutics application, industry observers have been saying for thepast two weeks that the firm is on the verge of announcing their first approval.

Intellipharmaceutics' state of the art manufacturing facility in Toronto produces oral solid dosage forms such as controlled-release and targeted-release tablets, spheres, beads and capsules. The manufacturing facility supports current and future drug applications by Intellipharmaceutics for the U.S. market.

Shares of the company have traded as high as $6.12 earlier in the year, but a poorly received financing and a now-settled patent infringement litigation with Wyeth LLC, a wholly owned subsidiary of Pfizer had cast a shadow of uncertainty on the stock. Intellipharmaceutics settled the suit and was granted a non-exclusive license to the patents in suit that will permit them to launch a generic of Effexor XR(R) in the United States following FDA approval of the product.



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