The FDA recently submitted a recommendation of approval to the Center for Drug Evaluation and Research (CDER) for UPM Pharmaceuticals to manufacture a low-dose tablet product. The recommendation was the culmination of a FDA Pre-Approval Inspection (PAI) of UPM’s facility and the manufacturing process for an NDA for one of its clients. The inspection covered general GMPs as well as product specific information.

“This accomplishment represents a significant achievement in UPM’s history and supports our goal of successfully developing products for client NDA submissions,” said John Gregory, UPM’s chief executive officer. “This recent development places UPM in an excellent position to continue to grow our company by providing expanding manufacturing services to our diverse client base.”

UPM Pharmaceuticals, Inc. is a Baltimore, MD-based CDMO providing customized formulation development, manufacturing, and analytical services to pharmaceutical, biotechnology, academic, and veterinary clients.

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