TESA-LABTEC-GMBH
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160224005987/en/
Contact:
tesa Labtec GmbH
Klaus Koehl
Director Business Development
Email:
Klaus.koehl@tesa.com
Phone:
+49-2173-9735-16
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Prilenia Enters into a Collaboration and License Agreement with Ferrer for the Commercialization and Co-Development of Pridopidine in Europe and Other Select Markets28.4.2025 07:02:00 CEST | Press release
-- Total deal size of approximately €500 million, including approximately €125 million in upfront and near-term milestones ---- Ferrer to commercialize pridopidine in Europe and other select markets; Prilenia retains full commercialization and development rights to pridopidine in North America, Japan and Asia Pacific ---- Co-development agreement in the territory supports further expansion of pridopidine in Huntington’s disease, amyotrophic lateral sclerosis and future indications ---- Pridopidine for Huntington’s disease is currently under review by the European Medicines Agency (EMA) with a CHMP opinion expected in the second half of 2025 -- Prilenia Therapeutics B.V., a biopharmaceutical company driven by an unwavering commitment to scientific excellence and accelerating progress for people affected by Huntington’s disease (HD) and amyotrophic lateral sclerosis (ALS), today announced that it has entered into a collaboration and license agreement with Ferrer for the commercialization
Ferrer Enters Into a Collaboration and License Agreement With Prilenia for the Commercialization and Co-Development of Pridopidine28.4.2025 07:00:00 CEST | Press release
Ferrer, an international B Corp pharmaceutical company with an increasing focus on rare neurological diseases, and Prilenia Therapeutics B.V.,a clinical-stage biotech company, have announced the signing of a strategic co-development and license agreement in which Ferrer obtains the rights to develop, manufacture and commercialize Pridopidine in the European Region, the Middle East and North African Region, the Southern African Region, the Central and South American Region, and the Commonwealth of Independent States Region. Pridopidine, a potent and highly selective, orally administered sigma-1 receptor agonist, designed to regulate key neuroprotective mechanisms that are often impaired in neurodegenerative diseases, is a promising candidate for the treatment of Huntington’s Disease (HD), a rare inherited neurodegenerative disease, with a high unmet medical need1. It has been studied in more than 1,700 people and long-term safety data of up to 7 years duration are available from previou
Innorna Announces FDA Rare Pediatric Disease and Orphan Drug Designations Granted to IN013 for Treatment of Wilson Disease27.4.2025 11:36:00 CEST | Press release
Innorna, a clinical-stage biotechnology company revolutionizing mRNA therapeutics with its innovative lipid nanoparticle (LNP) delivery technology, today announced the U.S. Food and Drug Administration (FDA) has granted both Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) to its investigational mRNA therapy, IN013, for treating Wilson Disease (WD). This dual achievement accelerates the clinical development of IN013, advancing Innorna’s mission to deliver transformative therapies for WD patients. About FDA Designations The Rare Pediatric Disease Designation (RPDD) incentivizes therapies for serious or life-threatening diseases affecting fewer than 200,000 U.S. patients, primarily those aged 18 or younger. Sponsors may qualify for a Priority Review Voucher (PRV) upon approval to expedite FDA review of a subsequent drug application. The Orphan Drug Designation (ODD) supports therapies targeting rare diseases (affecting fewer than 200,000 U.S. patients) by provi
Everen Specialty Appoints Carla Greaves Chief Underwriting Officer25.4.2025 19:00:00 CEST | Press release
Everen Specialty, a Bermuda-based (re)insurer for energy markets worldwide, today announced the appointment of Carla Greaves as its new Chief Underwriting Officer (CUO). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250425273777/en/ Carla Greaves Ms. Greaves will join the Executive Leadership Team of the Everen Group, based in the Bermuda office, later this year. She succeeds Jane Peterson, Interim CUO, who will continue in a consultancy capacity to facilitate the transition. With more than 30 years of underwriting and leadership experience in the (re)insurance industry, Ms. Greaves brings a wealth of expertise and a proven track record of success in the Casualty market where she is recognized for building high-performing teams, driving profitable growth, and successfully navigating complex market environments. Prior to joining Everen Specialty, Ms. Greaves held increasingly senior leadership positions, most recently servin
Incyte to Highlight Early-Stage Oncology Data at American Association for Cancer Research Annual Meeting 202525.4.2025 14:00:00 CEST | Press release
Incyte (Nasdaq:INCY) today announced that the Company will present new early-stage data from its oncology portfolio at the American Association of Cancer Research (AACR) Annual Meeting 2025 in Chicago, IL, from April 25–30. “At AACR we will be presenting data from early-stage programs across our oncology portfolio, including for patients with myeloproliferative neoplasms, ovarian cancer and other solid tumors,” said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. “These data will guide our approach as we advance our pipeline and seek to transform the treatment landscape for patients with cancer and myeloproliferative neoplasms.” Abstracts accepted for presentation at AACR include: Mini Symposium INCB177054 INCB177054: A Novel, Potent, Orally Bioavailable DGKα/ζ Dual Inhibitor Enhances T-Cell Function and Demonstrates Potent Antitumor Activity (Session Title: Novel Antitumor Agents. April 28, 4:50 p.m. – 5:05 p.m. ET (3:50 p.m. – 4:05 p.m. CT). Abstract #
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom