News and Media

UPM PHARMACEUTICALS®, INC. PASSES PRE-APPROVAL INSPECTION (PAI) FOR SOLID ORAL DOSE PRODUCT

 

On June 4, 2009 the FDA submitted a recommendation of approval to the Center for Drug Evaluation and Research for UPM to manufacture a low dose tablet product. This recommendation was the culmination of a FDA Pre-Approval Inspection (PAI) of our facility and the manufacturing process for an NDA for one of our 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", says John Gregory, CEO of UPM, "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-based contract development and manufacturing organization providing customized formulation development, manufacturing, and analytical services to pharmaceutical, biotechnology, academic, and veterinary clients.

 

Fully appreciating that time-to-market is critical, UPM offers remarkably flexible, affordable, and rapid outsourcing services designed to meet clients’ specific development and manufacturing needs. Our clients represent both small and large companies within the pharmaceutical and biotechnology industries, as well as academic institutions who have a focus on clinical studies.

Contact:
Frank Sorce
973-765-0131 (office)
sorce@upm-inc.com
UPM Pharmaceuticals®, Inc.
6200 Seaforth Street, Baltimore, MD 21224
Phone: 410.843.3738
Fax: 410.633.4438