Cardinal Health has been given the green light from the US Food and Drug Administration (FDA) to start manufacturing the first commercial drug at its new sterile facility in North Carolina.
The biologic drug, called Panhematin (hemin for injection), will be manufactured on behalf of Ovation Pharmaceuticals - a firm that specialises in developing medically necessary therapies in areas of unmet medical need.
Many pharmaceutical companies, such as Ovation, outsource their sterile manufacturing due to the associated complexities and specialised expertise required.
Capabilities of Cardinal's new facility include biopharmaceutical compounding and fill/finish of glass vials and lyophilisation, with pre-filled syringe capabilities becoming available in 2007.
The new facility currently has 82 employees and is expected to grow to 200 when it reaches full capacity, said the firm.
Panhematin is the only FDA-approved therapy for acute porphyria, a rare disorder that if left untreated may lead to long-term or permanent paralysis, coma or even death.
"The support from Ovation and Cardinal Health is critical to ensuring product supply as Panhematin is the mainstay of treatment," said Joseph Bloomer, Professor of Medicine and Director of the University of Alabama Liver Center.