FDA OK for Haupt Pharma’s Italian antibiotics plant

By Gareth Macdonald

- Last updated on GMT

Related tags Food and drug administration

US FDA clearance for Italian antibiotics production facility is important for global growth says German contract development and manufacturing organisation (CDMO) Haupt Pharma.

A Haupt spokesperson told in-PharmaTechnologist that the site, in Borgo San Michele, Latina, now holds Food and Drug Administration (FDA) approval to make two sterile penicillin products for the US market.

The US market has a great potential, it is important for us to be present. [FDA approval] also shows the high standards of good manufacturing practice at our company​.”

She added that successful inspection “gives a positive signal to the market and potential customers who wish to target the US market and makes clear, that Haupt Pharma is a strong and competent partner​.”

The facility, which was purchased from US drug giant Pfizer last February​, also makes non-beta lactam antibiotics for pharma industry customers on a contractual basis, supplying 80 national markets.

Italian generics

The Latina plant is also approved by Italian authorities to produce generic drugs demand for which is likely to increase, according to Haupt’s spokesperson.

 “[Although] the use of generics in Italian market is still not comparable to other markets such as Germany or UK…further growth is expected in the near future​,” explaining that, according to a L’uso dei farmaci report, use of generics grew 12 per cent in 2009.

The Italian generics market has traditionally made up a smaller proportion of the nation’s total pharmaceutical sales than other European nations, owing to the extended national patent supplementary certificates in place.

This restricted the sale of generics in Italy for a long time after the product had come off patent in other European countries.

Consequently the market was valued at $809m in 2007, according to a report by Espicom Business Intelligence​, which is less than in Portugal despite total pharmaceutical sales in Italy being six times as much.

However, the market is predicted to grow to $1.8bn by 2012 as big products come off patent and efforts to revise the laws covering generics gain pace.

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