In November 2013, Albany Molecular Research Inc (AMRI) received a US Food and Drug Administration (FDA) close-out letter for its Burlington, Massachusetts facility, ending years of sanctions after sterile manufacturing violations ended in a 2010 Warning Letter.
Now AMRI, through its new CEO William Marth, wants to use this “pivotal milestone” - as site manager Christian Phillips described it at the time – to increase both its fill/finish capabilities in the face of rising demand, and grow the CMO business further.
Marth told investors at the JP Morgan Healthcare Conference last week since the lifting of the Warning Letter, the fill/finish business is growing at a great rate, and is an area AMRI wants to expand.
“The demand for Fill & Finish is really tremendous now in the US. It was unfortunate that we had a warning letter,” he said, especially as other manufacturers had also received such warnings. “Since we’ve had that warning letter lifted the demand for our product in Burlington has grown at a great rate.”
However, though Burlington is good for Phase I- III material and small commercial fill/finish, AMRI is looking to grow the Phase III capability and commercial capability both organically and inorganically in order to mature the site, Marth said.
Challenging Patheon and Catalent?
Fill/finish expansion at Burlington would be used as a springboard to focus on the firm’s other manufacturing services, Marth – who tookover from founder and CEO for the past 22 years Thomas D’Ambra in September - continued.
He said: “As pharma beings to look more and more at outsourcing, we believe we can extend that business both into patches, potentially DPIs, some oral solid dose other areas.
“Now we are not looking necessarily to go head-to-head against Catalent, head-to-head against Patheon, but what we think we can do is add our CMO business on the higher value high technology products.”
Marth also spoke of expanding AMRI’s API manufacturing business, which, through its facilities in Rensselaer, India and Holywell, UK, mostly produces branded drug ingredients.
“We can take that business and direct it more towards the generic markets as well,” he told the room, adding AMRI is looking to increase its approximate $127m share of a $14bn market.
“We’ve looked at a variety of areas in APIs that we think we can excel in, cytotoxic, steroid, peptides, controlled substances. These are areas that we will look to focus on probably on in both an organic and inorganic basis.”
Marth, who began his career at generics maker Teva, recently recruited George Svokos – also from Teva – as General Manager of the API business, in order to “lead the charge” in focusing on generics, whilst another key hire - Vijay Batra as Managing Director of AMRI India – will also support this project.