Catalent Pharma Solutions' Buenos Aires plant completes first FDA audit

Published: 20-Aug-2009
Manufacturing

Catalent Pharma Solutions has successfully completed the first FDA general cGMP audit and pre-approval inspection of its pharmaceutical softgel facility in Buenos Aires.


Catalent Pharma Solutions has successfully completed the first FDA general cGMP audit and pre-approval inspection of its pharmaceutical softgel facility in Buenos Aires.

Catalent, headquartered in New Jersey in the US, has been operating in Argentina since 1953 serving local and regional pharmaceutical and consumer health markets. The company is completing a substantial expansion of the facility designed to meet FDA and other global regulatory standards.

The firm now has 20 sites approved to produce products registered with the FDA, with two new site approvals coming in the last 12 months. Many of Catalent's facilities are registered with other regulatory authorities, including the EMEA, and some facilities have multiple regulatory approvals.

Catalent provides advanced technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in around 100 countries.

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