The drug will be sold by Apotex in the US market.
“Under the terms of the agreement, Apotex shall be responsible for sales & distribution of the product in the USA and Panacea Biotec shall be responsible for manufacturing and Supply,” the Indian company said.
Panacea Biotec has already received tentative approval from USFDA for Prasugrel Hydrochloride.
It will be entitled to 180 days of shared marketing exclusivity for Prasugrel Hydrochloride after getting the final approval.
Prasugrel has annual sales of approximately S600 million in USA and is indicated for reduction of thrombotic cardiovascular events (including stent thrombosis) in people with acute coronary syndrome who are to be managed With percutaneous coronary intervention (PCI).
“Panacea Biotec and Apotex are also working on two drug delivery technology based, high barrier to entry anti-cancer generic products under their existing collaboration,” the company said.
Apotex Inc. is the largest Canadian-owned pharmaceutical Company, employing over 10,000 people in research, development, manufacturing and distribution facilities world-wide, the Indian company said.
Apotex produces more than 300 generic molecules in approximately 4,000 different dosages and formats which, in Canada, are used to fill over 85 million prescriptions a year – the largest amount of any pharmaceutical Company in this country.
Panacea Biotec is one of the largest vaccine producers and leading Biotechnology Companies in India.