AMW GmbH is a specialized pharmaceutical company based in Warngau, south of Munich in Germany.
We are market leaders in developing and manufacturing biodegradable slow-release drug delivery systems such as implants and vaginal rings, as well as first-to-market generics. In addition, we use our leading-edge galenic formulation expertise to support our partners in the development of new products based on our technology platforms.
Our products are distributed worldwide through renowned licensing and distribution partners from biotech, pharmaceuticals, and the generics sector.
The main focus of licensing is on indications such as oncology, neurology, endocrinology, ophthalmology, and pain treatment.
In most cases, we are the exclusive manufacturer of our products.
We are interested in long-term business relationships and work with reliable partners in a spirit of trust and cooperation.
Expansion of the partnership with Zentiva for Western Europe for which Zentiva wants to add our leuprorelin implant to its portfolio
Founding of the AMW GmbH Advisory Board
Completion of the manufacturing and development center Birkerfeld 19 in Warngau
Approval for a leuprorelin implant for the hormonal treatment of prostate cancer
Wholesale license in accordance with Section 52a of the German Medicinal Products Act (AMG)
Sale of the first leuprorelin implants by AMW’s own sales team
Conclusion of a financing agreement with the European Investment Bank with up to €25 million for research and development
Sale of the first rivastigmine and buprenorphine patches
Sale of the first goserelin implants by customers and construction of a production plant for implants
Approval of a goserelin implant for the hormonal treatment of prostate cancer and breast cancer, buprenorphine patches for the treatment of mild and moderate pain, and rivastigmine patches for the treatment of Alzheimer’s disease
Obtainment of a narcotics license in accordance with Section 3 of the German Controlled Substances Act (BtMG)
Sale of the first AMW products (scar reduction patches) by customers
ISO 13485 certification by the technical inspection service TÜV Süd
Construction of a production plant for transdermal therapeutic systems
Obtainment of a manufacturing authorization for medical products
Founding of AMW GmbH by Dr. Wilfried Fischer, who had previously sold Novosis AG, headquartered in Miesbach, Germany, to the Schweizerhall Group in Switzerland. Today, Novosis operates as part of Luye Pharma.
Dr. Friedrich Tegel has been Managing Director of Operations since January 2018. The chemist and biologist has worked in the pharmaceutical industry since 2002 and has more than 14 years’ experience in product development and pharmaceutical manufacturing. In August 2017, he was appointed Director of Operations at AMW. Previously, he held leading positions in development and operations at Novartis/Sandoz, including Head of Operational Excellence. In May 2020, he expanded his business unit at AMW to include development.
Philipp Karbach has been Managing Director since January 2019. The health economist joined AMW in September 2016. He has more than twelve years’ experience in finance and business development in the healthcare sector, mainly in management.
Dr. Frank Michel has been Director of International Business and Licensing since February 2019. The biochemist has more than 25 years’ experience in leadership roles in the international life science and healthcare industry in the areas of sales, marketing, and business development. Previously, he held leading positions in multinational companies such as Merck KGaA, as well as in midsize pharmaceutical companies.
Markus Kurzböck has been Head of Manufacturing since June 2019. A qualified pharmaceutical engineer and technical business management specialist, he has more than 15 years’ experience in the production of solid dosage forms. Previously, he held the position of Head of Manufacturing at Haupt Pharma Wolfratshausen GmbH.
Since November 2009, Dr. Dirk Barth has been employed as Head of Quality Control. The chemist was recognized as a qualified person (QP) in August 2011 and has been responsible for batch certifications performed in-house since then. He has 20 years’ experience in analytics, in the development of drugs and active pharmaceutical ingredients, and in GMP.
Dr. Sebastian Luci has been Head of Development since June 2020. After studying and completing his doctorate in food science, Dr. Sebastian Luci worked as Manager Drug Regulatory Affairs for six and a half years for mibe GmbH Arzneimittel (Dermapharm Group) in the field of regulatory affairs.
In addition, he taught at the Martin Luther University of Halle-Wittenberg for several years. In 2014, he moved to a midsize company in the eldercare sector, where he worked as a executive assistant with a focus on HR and quality management. Dr. Luci has been authorized signatory of Endomedica in Halle/Saale since February 2016. For the wholesale trade in pharmaceuticals, which has been operating since 2018, he also assumes the position of authorized person within the meaning of Section 52a of the German Medicinal Products Act and is a quality management officer certified by the German Technical Inspection Association (TÜV).
In order to be even better positioned from both a scientific and business perspective, AMW set up an advisory board in April 2019. Its members are Dr. Georg Ingram, Dr. Dirk Schrader, and Prof. Dr. Gerhard Winter.
This high-calibre advisory board supports the company in specific business challenges and in the decision-making process on strategic issues.
Dr. Georg Ingram is an expert in business development, licensing, and project management. With more than 20 years’ experience in various companies, including Pharmascience Inc., Actavis, and Alvogen, he makes an important contribution to AMW with his extensive background knowledge.
Dr. Dirk Schrader is Head of Global Technical Operations at Insud Pharma. Previously, he worked for Bayer, Bristol-Myers Squibb, and AstraZeneca. He possesses valuable leadership expertise and has considerable experience of the Asian market. Thanks to his experience and his pharmaceutical knowledge, he is also ideally placed to support AMW as an industry expert.
Prof. Dr. Gerhard Winter, Professor of Pharmaceutical Technologies and Biopharmaceutics, has been working with parenteral medication systems since 1988. During his career, he focused predominantly on product development and became highly knowledgeable in the field of development. As an expert in this field, he will offer AMW advice about specific issues.