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tesa Labtec GmbH

Booth number: 4507-4

www.tesa-labtec.com
bd-tesa-labtec@tesa.com

About us

tesa Labtec offers the development and manufacture of film shaped dosage forms (CDMO services) like transdermal and topical patches as well as oral, 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 offers its services to customer worldwide. Our sites in Langenfeld and Hamburg are FDA approved.



Products and services

Our products:

  • Transdermal and topical patches
  • Buccal and sublingual films

Our Services:

  • Contract development
  • Contract manufacturing
Mucofilm®

Mucofilm®

Our Mucofilm® technology creates a mucoadhesive film that enables transmucosal, drug permation. Thus gastroinestinal drug degradation cannot occur and the hepatic first-pass metabolism is bypassed. Therefore.buccal Administration opens up completely new possibilities for molecules with low bioabailability. Mucofilms® are easy to apply, handle and store. Patients can benefit tremendously from the prompt relief delivered by our Mucofilm® technology.

www.tesa-labtec.com/eng/mucofilm

Pharmaceutical Research and Development

Pharmaceutical Research and Development

Our R&D site in Langenfeld, Germany, is fitted with the most modern equipment for the development of innovative drug delivery Systems. The fomulation department has direct Access to all of the necessary development tools. Our in vitro testing group routinely performs Franz cell tests. State-of-the-art equipment and modern information technology ensure timely, reproducible results at a reasonable cost. The site complies with cGMP and is FDA approved.

www.tesa-labtec.com/eng/development_manufacturing/co...

Production

Production

tesa Labtec's production plant in Hamburg, Germany, is equipped with the latest state-of-the-art coating, converting and packaging Equipment in a cleanroom environment. It is fully dedicated to manufacturing patches and thin films for global customers. The site complies with cGMP and is FDA approved.

www.tesa-labtec.com/eng/development_manufacturing/co...

News & Innovations

Successful FDA Pre-Approval Inspection  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 concluding sessions 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. tesa Labtec has responded promptly to the observations which the Investigator had 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.

For any questions please contact:
Klaus Köhl
Director Business Development & Licensing
E-Mail:bd.tesa-labtec@tesa.com
Phone: +49 2173 97350

Contacts

Address
tesa Labtec GmbH
Raiffeisenstr. 4
40764 Langenfeld
Germany

Phone: +49 2173 97350
Fax: +49 2173 973535

Andrea Amelung
Assistant Administration and Marketing
Phone: +49 2173 973530
andrea.amelung@tesa.com


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