UIP HOSTS FDA INSPECTION

An FDA Inspector conducted a general cGMP and preapproval inspection of UIP in November 2015 (both the manufacturing and laboratory site were inspected). This preapproval portion of the inspection was for two different products; a generic sterile injectable solution manufactured by UIP and an oral, immediate release tablet product containing an NCE on which UIP performs finished product and stability testing. This latter product was originally formulated by UIP. The latter product is intended for the treatment of liver disease and is on an accelerated approval track. The inspector completed the inspection and did not leave a Form 483 at either site. This inspection brings to 4 the number of successful preapproval inspections UIP has hosted since 2009. This is a significant accomplishment for UIP.

NEW DRUG APPLICATION FILING

INTERCEPT PHARMACEUTICALS AND UNIVERSITY OF iOWA PHARMACEUTICALS

University of Iowa Pharmaceuticals (UIP) is pleased to report that its long standing client, Intercept Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic underserved liver diseases, announced on June 29, 2015 that it has filed a New Drug Application for accelerated approval with the U.S. Food and Drug Administration (FDA) and acceptance of the Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for obeticholic acid (OCA) which is intended for the treatment of primary biliary cirrhosis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. 

Intercept Pharmaceuticals, Inc. contracted with UIP to develop a preliminary formulation and analytical testing methods for this product when it entered the drug development process.  As the product moved through the development process, manufacturing operations were moved to another facility due to scale limitations at UIP.  Analytical testing has continued to be performed by UIP, and UIP is named as a qualified laboratory for testing of commercial product intended for United States market.  This is the fifth commercial prescription product for which a UIP client has filed for regulatory approval with UIP named as a production and/or analytical testing site in the past 6 years.

The read more about this: http://ir.interceptpharma.com/releasedetail.cfm?ReleaseID=919926 

UIP Featured in chemical and engineering news may 2015

chemical and engineering news recently featured UIP in an article on University-created pharma and biotech SERVICE operations

The article touched on a number of issues including the need for university based service organizations to focus of satisfying customer needs and operating like a commercial enterprise to be successful.  Such facilities must combine solid technical skills with entrepreneurial drive.  Read more...

1974 to 2014!

University of Iowa Pharmaceuticals celebrates 40th anniversary of gmp compliance

UI Pharmaceuticals is celebrating its 40th anniversary of producing cGMP drug products for use in clinical trials and commercial sale this month!  A lot has changed in 40 years, but UI Pharmaceuticals continues to provide cGMP contract services to the pharmaceutical industry.  Thanks to all of those who have used our services over the years.  UI Pharmaceuticals looks forward to providing cGMP pharmaceutical contract services for another 40 years and beyond!

Dale E. Wurster Endowment

The Dale E. Wurster Research Award in Pharmaceutics recognizes individuals who have made significant research contributions to the field of Pharmaceutics.  This research may be in the areas of physical pharmacy, preformulation, dosage form design, formulation, biopharmaceutics, and/or pharmacokinetics. This award was created and generously funded by Dean and Professor Dale E. Wurster for twenty years.  A fund raising initiative has been launched to permanently fund the award via an endowment. This reflects the strong support to memorialize Dean Wurster’s scientific contributions and to recognize him as a founder of AAPS.   University of Iowa Pharmaceuticals and College of Pharmacy will be the lead corporate sponsor of this endowment.