ANVISA - The regulatory agency of Brazil has approved the sterile cephalosporin manufacturing unit of Alkem Laboratories Ltd.
The highlight of this approval lies in the fact that, this manufacturing unit of Alkem, is one of the very few sterile manufacturing units in the country to receive ANVISA approval, a company release said.
Samprada Singh, chairman of Alkem Labs said "This ANVISA approval marks our foray into the huge Latin American Generic market, wherein Brazil assumes paramount importance. We will expand into the other markets as well very quickly".
Sequel to this approval, Alkem hopes to market around 10 sterile formulations through regional strategic partners.
This cephalosporin unit of Alkem has already been approved previously by UK MHRA & MCC (South Africa).
"We will target a sale of around US $ 10 million from Latin America in the next 2 years" stated S M Raina, Sr. V P (International) at Alkem.