Albemarle tells CW that it is planning a large-scale expansion at the company’s cGMP active pharmaceutical ingredient (API) production facility at South Haven, MI, next year. “We are looking to expand the South Haven site further next year and we are in the process of deciding the details of the expansion plans,” Kurt Hoeprich, global business manager/pharmaceuticals at Albemarle tells CW at the CPhI trade fair in Paris being held from 7-9 October. “This will be larger-scale expansion, and it will be dictated by how our customer’s programs progress,” he says.
The South Haven facility is Albemarle’s only cGMP site. The other pharmaceutical manufacturing facilities of the company, which are all located in the United States, make basic and advanced pharmaceutical intermediates that feed into the South Haven site. Albemarle is currently also completing a previously announced expansion at South Haven. “We have dramatically expanded our kilo lab capabilities at South Haven because most of our customers want us to start early in the development process. We used to start in late Phase I and Phase 2; now customers want us to start earlier and that is what has caused that investment. The expanded kilo lab will become operational by the end of November,” Hoeprich says. “We have also expanded solids handling capabilities at the site this year,” Hoeprich says.
The pharmaceutical sector is the fastest growing sector within the fine chemistry services business of Albemarle, the company says. “The pharmaceutical business is seeing double-digit growth and is growing faster than the agrochemical business within the fine chemistry services business,” Hoeprich says. The fine chemistry services business recorded sales of $288 million in 2013, compared with $322 million in 2012, and the primary reasons for this decline “were the decline in sales of certain agrochemical products and certain specialty polymer projects; agrochemicals and specialty polymers are the more mature areas within our portfolio,” Hoeprich says. “The market for custom manufacturing of pharmaceutical intermediates and APIs, as well as our generic business are both growing very well.”
Earlier this year, the SI Group (Schenectady, NY) agreed to acquire the antioxidant, ibuprofen, and propofol businesses of Albemarle for an undisclosed amount, and the sale includes a facility at Orangeburg, SC. The ibuprofen and propofol businesses are part of Albemarle’s fine chemistry services business. “The primary driver behind that deal was the antioxidant business. The Orangeburg antioxidant site had a separate cGMP section where ibuprofen, and propofol are produced. It was difficult to split the site. The SI group is involved in the business of raw materials for ibuprofen and so it made strategic sense for them to buy the whole site. The sale has allowed us to sell the site in tact and allowed the fine chemistry services business to focus resources on the high growth areas, especially new chemical entities [NCEs],” Hoeprich says.The annual revenue for the fine chemistry services business this year will be affected by the divestment of the businesses to SI. The company meanwhile plans to grow its pharmaceutical business further. “The sweet spot in the market for Albemarle when you look at the South Haven capabilities tends to come from biotech companies or mid size specialty pharma companies. The common characteristic between those customer types is that they do not have internal manufacturing capacity or do not plan to ever have internal manufacturing and will outsource all their API needs. Our goal is to look for those customers. We really look for customers who want to have a long-term relationship and this is where the kilo lab comes in. We can take the project from a very early stage and stay with it through commercial phase,” Hoeprich says. “Companies are pursuing more targeted therapies especially in oncology, and we do have an increasing number of oncology products in our portfolio, but we would not be categorized as a high-potency manufacturer. We are looking at the possibility of expanding into high potency APIs but there are no firm plans as yet,” Hoeprich says.
Albemarle says it also considering growing its pharmaceutical business inorganically. “We have been actively looking at acquisitions for a while and we are open to acquisitions in any geographic region, but it has to complement our capabilities in South Haven,” Hoeprich says.
By Deepti Ramesh in Paris
Source: Chemistry Week
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