LANGENFELD, Germany–(BUSINESS WIRE)– The German patch and oral thin film maker announces the completion of a Pre-Approval Inspection (PAI) by the US Food and Drug Administration (FDA) in February 2016.
During a total of 7 days of inspection, FDA visited both, the R&D site in Langenfeld as well as the manufacturing facility in Hamburg, Germany. FDA provided feedback with a short list of observations which tesa Labtec takes seriously. At the conclusion of the inspections, the FDA Investigator said that the initial conclusion was to approve the sites for commercial activities. That conclusion must still be reviewed within FDA. The company is responding promptly to the observations which the Investigator raised.
“This FDA inspection demonstrates a significant milestone within our plan to expand our business to the US market.” stated Dr. Ingo Lehrke, Managing Director of tesa Labtec. “The inspection paves the way to the US market for our customers’ transdermal patches and oral thin films and certifies the high quality of our development and manufacturing capabilities. This achievement was made possible through the dedication of our talented staff.” Dr. Lehrke concluded.
The PAI was triggered by a customer’s ANDA filing for a transdermal patch, which is manufactured by tesa and is designated for US distribution.
About tesa Labtec GmbH
tesa Labtec offers the development and manufacture of film shaped dosage forms (CDMO services) like transdermal and topical patches as well as buccal or sublingual films. The business activities comprise formulation development, scale up and manufacture of clinical trial supplies or finished products under full cGMP conditions. Thereby tesa counts on its proprietary technologies Transfilm ®, Rapidfilm ® and Mucofilm ®. tesa Labtec is a wholly owned subsidiary of tesa SE, a member of the Beiersdorf group of companies, and represents the pharmaceutical business in a truly global family of companies.
tesa Labtec GmbH