The company will produce the drug at its facility in Winchester, Kentucky, which recently doubled its footprint to 180,000 square feet. The expansion added new fluid bed capacity, expanded analytical laboratories and created an open facility designed to provide greater flexibility.
Under the long-term supply agreement with Pfizer, the Winchester plant will formulate and manufacture the 2-milligram Proton Pump Inhibitor drug into enteric coated, delayed release pellets using fluid bed technology. Catalent will also encapsulate these pellets into two-piece, hard-shell capsules.
Catalent said it has invested extensively in capsule banding technology required for OTC products.
“Nexium is one of the leading global OTC medicines, and its manufacture is well suited to our recently expanded Winchester facility, where we have both the capacity and flexibility to accommodate programs of this scale,” commented Barry Littlejohns, Catalent’s president of Advanced Delivery Technologies.
Catalent decided to expand its Winchester facility in response to increased customer demand for the manufacture of complex, oral solid formulations. The site has been operating for more than 20 years, producing more than 3 billion tablets and capsules annually and launching more than 100 new products into the market since its inception.
Pfizer secured exclusive global rights to market Nexium for OTC indications from AstraZeneca in 2012. AstraZeneca continues to manufacture and sell the prescription product.