Pii Continues To Lead in Pharma Product Development

Pii Continues To Lead in Pharma Product Development

Pii’s senior business development director, Gregory Gonzales, spoke with Contract Pharma at BIO about services & recent news

Pii is a science-driven contract development and manufacturing organization (CDMO) providing dosage form development and cGMP manufacturing services to the global pharmaceutical industry.

Founded in 1994, Pii has grown from 12 employees to over 300 scientists and support staff and over 430,000 square feet of space in the U.S. Pii's cGMP facilities are state-of-the-art and contain over 70 manufacturing rooms as well as containment suites for handling high potency compounds and hormones, dedicated manufacturing suites for soft gels and injectables, a formulation development center, and analytical laboratories. Pii’s facilities have been inspected by both the FDA and EMEA and are registered with the DEA.​ 

In recent news, Pii received notification from the MHRA that the previously restricted GMP Certificate would be withdrawn based on the Mutual Recognition Agreement (MRA) and recent inspections conducted by the FDA.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 stated that "following confirmation from the USFDA, 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. 

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