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read morePODD – Partnership Opportunities in Drug Delivery
October 28-29, 2024 Boston, USA https://poddconference.com
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November 04-06, 2024 Stockholm, Sweden https://informaconnect.com/bioeurope/
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February 27-28, 2025
London, UK
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BIO-Europe Spring
March 17-19, 2025
Milan, Italy
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New York City, USA
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Latest
News
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.
read moreAMW 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
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.
read moreObtaining manufacturing permission for sterile products
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
read more