The certification programme, which has been achieved by only 10 organisations since its introduction in 1999, covers all aspects of potent compound production, from containment to operator training and safety.
Schulz told in-PharmaTechnologist that “AMRI made a significant contribution in time and resources to complete this outside expert review of our capabilities and systems as part of a commitment to ourselves and our customers that we are operating at the highest standard for state-of-the-art for HPAPI synthesis.
“SafeBridge is recognized as world-renowned authority in this field and their opinion is well-respected and sought out by companies who are advancing high potency APIs into drug manufacture.”
She predicted that demand for high potency active pharmaceutical ingredient (HPAPI) manufacture which, in common with the rest of the drug industry has slowed in the downturn, will “return to recent strong levels” as the economy recovers.
Global API market
AMRI has made HPAPIs and considered them a core competency for more than 15 years according to Schulz, who rejected the idea that in recent times Western API makers have focused on this area of the market in the face of low-cost Asian competition.
She said that, from AMRI's perspective, “while Asian manufacturers have made pricing more competitive, our continued expansion in India, and in other locations worldwide, as established by our US-based operations, positions us to offer customers’ solutions from an extensive pool of technologies, resources and cost structures to competitively position AMRI in this growing industry.
“We believe HPAPI synthesis and controlled substance manufacturing are a niche where AMRI can excel and we will continue to look for opportunities to expand our relationships for this challenging and valuable work.”