Hunt Valley, Maryland - Pharmaceutics International, Inc. (Pii), a contract development and manufacturing organization specializing in the development of difficult to formulate compounds, today announced it has commenced construction of their new 24,000 sq. ft. cGMP aseptic fill/finish manufacturing facility. The expansion of Pii's Hunt Valley campus is focused on meeting current client projects with near-term commercial manufacturing needs and new client demand for larger batch sizes.
Targeted for completion in the fourth quarter 2012, the new facility will more than double the company's current sterile GMP manufacture capacity. Fill/finish suites will include automated vial and syringe filling, inspection and labeling equipment capable of producing batch sizes of 100,000 plus units.
The facility expansion closely follows the company's recent United States Food and Drug Administration (FDA) pre-approval inspection (PAI). As a result of this inspection Pii was approved to commercially manufacture an aseptic vial in their existing Hunt Valley aseptic facility.
"Pii has demonstrated its expertise in sterile product development and aseptic manufacturing, offering our clients a quality product with strict adherence to regulatory compliance standards," stated Steve King, senior vice president of Pii. "The additional facilities will enable us to support our clients from pre-clinical through commercial-scale production and meet the growing demand for fill/finish services for potent compounds and oncology drugs."
Pharmaceutics International, Inc. (Pii) is a privately held contract development and manufacturing company providing dosage form development and GMP manufacturing services to the global pharmaceutical industry. Pii's vision is to become the benchmark in pharmaceutical product development and commercial manufacturing outsourcing. Headquartered in Hunt Valley, Maryland USA with European facilities in the UK, Pii offers preformulation testing, formulation development and Clinical Trial Material and commercial manufacture of solid, parenteral, inhalation, semi-solid and liquid dosage forms. For further information about PII visit