Pharmaceutics International, Inc. (Pii) Announces cGMP Aseptic Facilities Expansion

Pharmaceutics International, Inc. (Pii) Announces cGMP Aseptic Facilities Expansion

HUNT VALLEY, Md., Jan. 18, 2012 /PRNewswire/ -- 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."

About Pharmaceutics International, Inc.

Pharmaceutics International, Inc. (Pii) is a privately held Drug Delivery Solutions 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 outsourcing. Headquartered in Hunt Valley Maryland USA with European development and manufacturing facilities in the UK, Pii offers preformulation testing, formulation development and clinical trial material and commercial manufacture of parenteral, solid, semi-solid and liquid dosage forms. For further information about Pii visit www.pharm-int.com.

Contact:
Elizabeth Hickman, Marketing Manager
Pharmaceutics International, Inc.
10819 Gilroy Road
Hunt Valley, MD 21031
Phone: (443) 858-0768
Email: [email protected]

SOURCE Pharmaceutics International, Inc. (Pii)

 

Suggested Articles

Saturday, AstraZeneca revealed more of the data that convinced the FDA to green-light Calquence in previously untreated chronic lymphocytic leukemia.

The efficacy between Keytruda and FerGene's nadofaragene firadenovec look comparable in their studies, though Merck has at least one upper hand.

Thursday, the FDA approved the first three generic versions of Gilenya, but they may not hit the market anytime soon due to ongoing litigation.