Regulatory

The US Food and Drug Administration (FDA) completed its most recent inspection of PrimaPharma’s manufacturing facility in November 2014.  The entire facility and the quality systems used for the manufacture and release of drug products were subjected to a detailed compliance inspection.  The inspection found the facility to be compliant with the principles and guidelines of current Good Manufacturing Practices (cGMPs).

In addition, PrimaPharma has hosted successful PAIs (Pre-Approval Inspections) associated with customer’s Abbreviated New Drug Application (ANDA) filings with the FDA.  The company is also current on its Food and Drug Branch (FDB) License, which is required for commercial drug and medical device manufacturing in California.