Fresenius invests in Oz plant; says recalled mouldy cancer drugs no risk

Fresenius Kabi has announced plans for a new $47m (€34m) infusion products manufacturing and cancer drug compounding facility in Australia.

The German-owned medicinal products firm has chosen a site in the Melbourne suburb Derrimut for the new 40,000 square meter facility which it says will create 120 manufacturing jobs.

Company spokesman Mathias Link told in-Pharmatechnologist.com that when operational in 2015 “the plant will produce infusion solutions, irrigation solutions, IV generic drugs and compounded oncology products” for public and private hospitals Australia.

According to a report in the Herald Sun newspaper the plant will supply as many as 180 hospitals with 29m intravenous bags and drug delivery systems. Fresenius Kabi also stressed that the facility will run a 24-hour production schedule to ensure demand is met.

State funding

The new construction project is being supported by a grant from the Victoria State Government, which has A$55m ($49m) set aside to fund development of industrial biotechnology in the region.

Victoria is already one of Australia’s key drug manufacturing hubs as a result of a number of recent manufacturing expansions by suppliers based in the State.

In 2009, for example, generic drugmaker Sigma Pharmaceuticals expanded its Melbourne facility through a $9.6m investment designed to cement its already leading position in the Australian drug market.

More recently, in March last year, Mumbai-headquartered Cipla chose Victoria as the location for its first regional office outside India.

Queensland recall

News of the investment in Victoria comes just a few weeks after Fresenius Kabi recalled compounded cancer drugs in the neighbouring State of Queensland over safety concerns.

According to a recall notice on the Therapeutic Goods Administration (TGA) website the firm issued a class I recall of a range of cancer drugs it had compounded after environmental quality control analysis detected some high mould counts.

The firm said that: “A risk assessment by Fresenius Kabi concluded that there is a potential risk for patients as the sterility of product may have been compromised.

It added that it has “not received any reports of adverse events associated with this failure” and that further to the recall identified that there is no evidence for actual contamination of the compounded products and therefore there is no hazard to human health.”