Pharmaceutics International, Inc. (Pii), a CDMO based in Hunt Valley, MD, received notification from the Medicines and Health Care products Regulatory Agency (MHRA) that the previously restricted GMP Certificate would be withdrawn based on the Mutual Recognition Agreement (MRA) and recent inspections conducted by the FDA.

The notification said, “following confirmation from the U.S. FDA, Pii sites at Hunt Valley (Pii1) and Cockeysville (Pii3) and associated laboratories and storage facilities are now considered to operate in general compliance with GMP.”  The FDA conducted inspections of Pii in the fall of 2017 and recently issued Establishment Inspection Reports (“EIR”) associated with these inspections.  The FDA also confirmed that Pii’s parenteral facility is now approved for product profile codes for both terminally sterilized products (SVT) and aseptically filled products (SVS). 
 
The lifting of the restricted license means that any existing and future EU Marketing Authorization applications will now be supported by a Certificate of Pharmaceutical Product required from U.S. FDA and any EU clinical trial applications will be supported by QP declaration for Import.  Pii will be able to continue to support ongoing as well as new clinical studies in the U.S. and EU for oral solid, liquid, topicals and injectable drug products.  
 
Dr. Syed Abidi, chairman and chief executive officer, said, “The withdrawal of the restricted license based on mutual recognition between MHRA and FDA demonstrates Pii’s commitment to regulatory compliance, with a focus on continuous quality improvements and strengthening of overall quality systems within the organization. Along with our partners, we’ve received FDA market approval for seven products and commercially launched six products in 2017.  We anticipate approval of a minimum of three products by the end of the year.”