Wacker Biotech announce FDA approval to manufacture thrombolysis drug by Chiesi called Retavase®
Wacker Biotech GmbH (Jena, Germany) have announced that they will manufacture the active ingredient in the drug Retavase®, which will then be marketed by the pharmaceutical company Chiesi (NC, USA). The drug has obtained FDA approval and is utilized to treat acute myocardial infarction in adults.
Wacker Biotech have transferred the manufacturing process of the drugs active ingredient, termed reteplase, to its GMP facility in Halle, Germany. The company obtained approval for the commercial manufacture of the active ingredient 3 months after the FDA inspected the facility in Germany. When Retavase® is administered to acute ST-elevation myocardial infarction patients the active ingredient – a tissue plasminogen activator – causes dissolution of blood clots.
Susanne Leonhartsberger, managing director of Wacker Biotech, commented: “We are very pleased with the FDA approval of Chiesi’s product Retavase® for the US market. This allows us, as a contract manufacturer, to contribute to the treatment of serious illnesses such as a heart attack.
“I am very proud of the entire WACKER team that spent years establishing and implementing the required production process at our plant and has now achieved FDA approval for manufacturing, too. This confirms that our plants and processes are fully compliant with the most stringent of requirements. All of our customers can profit from this extensive expertise and know-how – from generating the cell line, to the transfer and optimization of existing manufacturing processes, to commercial market supply.”
Alan Roberts, Senior Vice President, Scientific Affairs for Chiesi USA, concluded: “This approval represents a significant milestone in Chiesi’s work to bring Retavase® back to the US market. WACKER is a proven leader in microbial technology. The collaborative effort and partnership have been outstanding.”
Source: www.wacker.com/cms/en/press_media/press-releases/pressinformation-detail_88192.jsp?
