For non-sterile drug production at Pianezza plant in Italy
Aesica has received official accreditation from Japan’s ministry of Health, Labour and Welfare, enabling it to manufacture and supply non-sterile drugs to the Japanese market.
The five-year accreditation was awarded to the UK pharmaceutical manufacturer’s plant at Pianezza in Italy and classifies Aesica Pharmaceuticals as a certified foreign drug manufacturer.
The Pianezza plant has a line dedicated purely to drug production for a leading pharmaceutical organisation in Japan and the accreditation will allow Aesica to continue to supply the company until 2016.
Aesica says the accreditation is strategically crucial, as it plans to expand further into Asia throughout 2011 and 2012.
Simon Clough, managing director of Aesica’s Formulated Products Business Unit, says: ‘Since acquiring the manufacturing site at Pianezza earlier this year from UCB, we have been determined to establish long-term strategic supply partnerships with the site’s original clients, as well as introducing new business streams.’
He added: ‘This accreditation is an essential element of our vision for the site, as the Japanese market is an arena we hope to heighten our presence in and to be recognised officially as an approved manufacturer of non-sterile drugs is a vital stage in this process.’
Aesica is a leading full-service provider of contract research, development and manufacturing services for formulated products and active pharmaceutical ingredients.