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FPP Inks ANDA Generic Deal

Upon approval, manufacturing will be performed by the CDMO Novocol.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Florida Pharmaceutical Products, LLC (FPP,) a pharmaceutical company involved in the development, sales, marketing and distribution of generic pharmaceuticals, and Ayrton Saunders Ltd. (ASL) a company involved in the development and licensing of pharmaceuticals, have signed an agreement for the licensing of an ANDA developed by ASL’s affiliate company Impopharma Canada Limited, currently filed with the FDA and expected to be approved mid-2020.
 
The product has sales of approximately $70 million according to IQVIA and limited generic competition. The ANDA product will be sold and Distributed by FPP in the FPP Label, once approved.
 
“We are very pleased to have this opportunity and look forward to launching this product next year,” said Larry J. Lapila, president of FPP.
 
The ANDA will be transferred to FPP upon approval and manufactured under a separate agreement by Novocol Pharma, Inc. (NPI) Ontario, Canada. Novocol is a contract development and manufacturing organization (CDMO) based in Ontario, Canada that specializes in cartridge based injectables, combination products and unit dose nasal sprays. The CDMO operates from its 200,000 square foot manufacturing plant located in Cambridge, Canada, serving U.S., Canadian and international markets.

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