AMW Receives Notified Body Opinion by TÜV SÜD for its Leuprorelin Implant in Pre-Filled Syringe
Warngau, Germany, May 15, 2024
AMW GmbH, a specialty bio-pharmaceutical company focused on innovative sustained-release drug delivery systems, today announced that it has received the final report of the Notified Body Opinion (NBO) for its leuprorelin implant in pre-filled syringes. The NBO completes a diligent conformity review procedure by a notified body, in this case TÜV SÜD. Thus, after official assessment, the applicator of the leuprorelin implant complies with the relevant general safety and performance requirements (Annex I) of the new European legislation, EU Regulation 2017/745 (MDR).
“It is a great achievement for AMW, and we are very proud of having received the NBO for leuprorelin by TÜV SÜD”, commented Elisabeth Wood, Senior Regulatory Affairs Manager of AMW. “This shows high quality and regulatory compliance of our integral drug-device combination product and paves the way for further approvals of leuprorelin, thereby opening new markets within the European Union and beyond. After TÜV SÜD had already issued the NBO for goserelin in July last year, this now marks the second positive conformity assessment for our products within a short time.”
Since May 26, 2021, a NBO (or CE marking) is a mandatory part of the EU registration procedure for integral drug-device combinations, such as AMW’s goserelin and leuprorelin implants in pre-filled syringes. This procedure requires accurate and detailed documentation verifying the safety and performance of the applicator from release to the end of shelf-life of the medicinal product.
AMW develops and produces innovative, bio-degradable sustained-release drug delivery systems, such as the GnRH analogue implants goserelin and leuprorelin. For global commercialization, the products are licensed to international and regional partners. AMW is the exclusive manufacturer and provider of these implants and receives royalties on licenses from its partners.
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About AMW:
AMW GmbH is a specialty bio-pharmaceutical company focused on biodegradable sustained-release drug delivery systems, providing patients and partners access to value-added medicines and cost-effective therapies. Based on its technology platform, the Company builds on a growing own and partnered development pipeline. AMW has two approved products, goserelin and leuprorelin implants, which are distributed worldwide through both local and global pharma partners. In Germany, leuprorelin is marketed as Leugon® by AMW’s wholly owned subsidiary Endomedica GmbH. To support pharma and biotech partners in the development and manufacturing of their products and life-cycle solutions, AMW uses its leading-edge formulation development expertise.
AMW is based in Warngau near Munich, Germany.
About Leuprorelin:
Leuprorelin implants contain the active ingredient leuprorelin and belong to the class of GnRH agonists (analogues of gonadotropin releasing hormone) which interfere with the regulation of sex hormone balance. As a consequence, testosterone levels are lowered in men and estradiol levels are lowered in women. This artificially induced lowering of hormone levels enables the symptomatic therapy of hormone-dependent tumors such as prostate cancer or breast cancer. AMW’s leuprorelin is administered in the form of a biodegradable implant which releases the active ingredient over a period of three months.
For further information please contact:
AMW GmbH
Eva Hoffmann
Phone: +49 8024 470999-0
E-mail: news@a-m-w.eu