FDA clears APP’s Barceloneta plant

By Gareth Macdonald

- Last updated on GMT

Related tags: Puerto rico, Revenue, Heparin

APP Pharmaceuticals, currently the sole supplier of therapeutic heparin vials to the US market, has received FDA approval to manufacture three new formulations of the blood-thinner at its plant in Barceloneta, Puerto Rico.

The generic drugmaker, which is being purchased by German Fresenius for $3.7bn (€2.5bn), said that the Food and Drug Administration (FDA) clearance will help it both fulfil existing orders and ensure an uninterrupted supply of heparin to US customers.

Tom Silberg, APP’s CEO, commented that approval for the Barceloneta plant, which is the firm’s third to receive FDA clearance, will allow it to: “Redeploy some of [its] manufacturing capacity at [its] two other facilities toward the production of other products​.”

APP replaced fellow US company Baxter Healthcare as the country’s primary heparin supplier following the latter firm’s withdrawal of its product which was found to contain the contaminant oversulfated chondroitin sulphate (OSCS).

The resulting additional heparin sales helped APP’s second quarter income from critical care products reach $113.5m, up around 27 per cent on the comparable period last year.

Despite total revenue growth of 24 per cent to $197.9m, due to increased turnover from critical care and analgesic/anaesthetic products, APP's quarterly net income from continuing operations grew just 4.8 per cent to $23.9m as costs associated with setting up the Puerto Rico facility impacted on performance.

Expansion of Puerto Rico plant

At present, APP manufactures nine of its drugs in Barceloneta, including doxycycline, azithromycin and diphenhydramine, although this is set to increase markedly as a result of its decision to transfer the production of an additional 25 products to the site.

The firm, which is conducting technology and stability assessments in preparation for the switch, anticipates that the facility’s output will increase from its current level of about 19m vials a year to around 50m when the transfer programme is completed.

Speaking about the firm’s recent investment programme, which amounts to around $80m in the recent years, APP chairman Patrick Soon-Shiong said that both the Barceloneta Plant and the firm’s facility in Green Island, New Jersey, had been the main focuses of the company’s infrastructure spending.

Related topics: Markets & Regulations, QA/QC

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