Raj Iyer, president of Arch Pharmalabs USA, told Outsourcing-Pharma few India-based contract manufacturing organisations (CMO) have high potency active pharmaceutical ingredient (HPAPI) capacity.
Arch has joined the sector with the addition of HPAPI capacity near Mumbai, India. Having base-loaded the site with soon to be generic APIs, Arch has begun receiving approaches from US innovators seeking to outsource production of new chemical entity-based intermediates.
Iyer expects the profitability of the sector will prompt other CMOs to consider entering the market. However, the high barrier to entry created by the need to prevent contamination is likely to limit the number of companies entering the sector, said Iyer.