Category: News

28. August 2015

BfArM approvals from DCP procedure for Rivastigmin patches granted for Germany, Austria, Romania, Sweden, Slovakia and the Czech Republic

On 28 August 2015, the BfArM granted approvals from DCP procedures for rivastigmin patches at doses 4.6 mg/24 h and 9.5 mg/24 h for Germany, Austria, Romania, Sweden, Slovakia and the Czech Republic.

6. September 2014

Successful financing round for pharmaceutical company AMW

AMW GmbH (Arzneimittelwerk Warngau) has received follow-on financing to advance the development and commercialization process for its drug delivery systems. Together with BayBG Bayerische Beteiligungsgesellschaft, UnternehmerTUM-Fonds and IBG Beteiligungsgesellschaft, the existing investors are putting in a total of up to seven million euros. The funds will be used for the marketing of the existing product portfolio and the development of a new technology for the controlled release of pharmaceuticals. AMW GmbH produces active ingredient implants as well as transdermal systems in the fast-growing fields of oncology, pain therapy and neurology.

26. February 2014

AMW GmbH announces that another round of financing has been concluded with the existing shareholders.

AMW GmbH announces that another round of financing has been concluded with the existing shareholders. The funds are used to strengthen further growth and the development of innovative products. Dr. Wilfried Fischer, managing director of AMW GmbH, thanks for the trust of the shareholders in the performance of the company.

2. January 2014

In January 2014, AMW GmbH was able to conclude a semi-exclusive license and supply contract for its biodegradable goserelin implants with a multinational pharmaceutical company.

The contract applies to Southeast Asia, including China, Eastern Europe, Russia and some Western European countries. The agreements contain down payment payments of up to € 10 million, license payments in the double-digit percentage range, and an exclusive delivery agreement for AMW. The partner company will carry out further clinical developments for the contract area.

7. October 2013

AMW GmbH has been successfully certified by Tüv Süd to EN ISO 13485: 2012/AC: 2012

Nr.ISO Certificate: Q21-13.07.84140.001
Validity: from 07.10.2013 to 06.10.2016
Scope: Manufacture, quality control, quality assurance and distribution of medical devices in plaster form
Applied standard(s):
EN ISO 13485: 2012/AC: 2012
Medical devices
Quality management systems
Requirements for regulatory purposes

2. May 2011

Obtaining unrestricted manufacturing permission for transdermal systems and drug implants

Type of inspection: General GMP inspection in accordance with Section 64 of the German Medicines Act (AMG), the provisions of the German Medicines and Drug Manufacturing Ordinance (AMWHV) and the EC-GMP Guide for the Acceptance of the New Manufacturing Rooms of AMW GmbH for the Production of Transdermal Systems, Verification of Systems for the Production of Clinical Test Samples and Manufacture of Market Goods for The Products: Transdermal Systems and Implants and for obtaining manufacturing authorisation for Market Goods.