Aesica Awarded Japanese Accreditation for Non Sterile Drug Production
Aesica has received an 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 Aesica’s manufacturing site at Pianezza in Italy and is in accordance with Article 13-3 of the Pharmaceutical Affairs Act, which classifies Aesica Pharmaceuticals as a certified foreign drug manufacturer.
Aesica’s Pianezza site 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 when a new accreditation will be required.
Such an accreditation is strategically crucial for Aesica, as it plans to expand its operation further into Asia throughout 2011 and 2012. The company currently has an office in Shanghai, but plans to increase its supply to Japan and other Asian countries from its existing sites in Pianezza and across Europe, as well as establishing a manufacturing presence in Asia.
More importantly, the certification clearly differentiates Aesica from many of its competitor contract manufacturers as the accreditation denotes the company’s technical capability in the non sterile market. As the Japanese pharmaceutical industry is the second largest individual market after the US, to meet the ministry’s stringent requirements for quality and compliance is a major achievement for Aesica.
Simon Clough, Managing Director, Formulated Products Business Unit, Aesica, says: “Since acquiring the manufacturing site at Pianezza earlier this year from leading bio pharma company, 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. 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. The company develops long-term strategic partnerships with its clients, responds quickly and effectively to market demand and develops tailored solutions for specific requirements.