Cardinal gets green light for new sterile facility start-up

By Kirsty Barnes

- Last updated on GMT

Related tags Medicine

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.

Related news

Show more

Related products

show more

Increasing the Bioavailability of Oncology Drugs

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Efficient Freezing & Storage of Biopharmaceuticals

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Addressing Challenges with Clinical In-Use Testing

Addressing Challenges with Clinical In-Use Testing

Content provided by Lonza | 12-Oct-2023 | White Paper

Lonza Drug Product expert Léa Sorret PhD explores Clinical In-Use Testing of Biotherapeutics in this white paper. Léa shares her expertise and describes...

Related suppliers

Follow us


View more