Catalent Pharma Solutions completes the first FDA general cGMP audit

Catalent Pharma Solutions announces the recent successful completion of the first FDA general cGMP audit and pre-approval inspection of its Buenos Aires, Argentina pharmaceutical softgel facility, with no reported observations on FDA Form 483. Catalent has been operating in Argentina since 1953 serving local and regional pharmaceutical and consumer health markets, and is completing a substantial expansion of the facility designed to meet FDA and other global regulatory standards.

Catalent now has 20 sites approved to produce products registered with the FDA, with two new site approvals coming in the last twelve months, further demonstrating Catalent’s ongoing commitment to regulatory compliance and expanding their global network to meet customer needs. In addition, many of Catalent’s facilities are registered with other regulatory authorities, including the EMEA, and some facilities have multiple regulatory approvals. In Fiscal 2009 alone, Catalent underwent 10 pre-approval and other inspections by the FDA, along with hundreds of other audits from regulatory authorities and customers.

“As we celebrate the 75^th anniversary of our softgel business, I am very pleased to have reached this important milestone for our global network. This brings our customers an important new supply chain option which further expands Catalent’s global sourcing flexibility. We welcome the opportunity for our experienced team in Buenos Aires to serve new customers, and to build upon their long history of operational performance, quality and compliance,” said Thomas Stuart, the Group President of Catalent’s Oral Technologies segment.