Wacker Biotech said today that it won FDA approval to start producing reteplase, the active ingredient in Chiesi‘s thrombolysis drug, Retavase.
The medication, which is designed to treat acute myocardial infarction in adults, will be marketed in the U.S. by Chiesi and made in Wacker’s Germany-based plant.
Wacker reported that it landed approval to commercially manufacture reteplase for the U.S. market just three months after the FDA inspected its facility.
“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,” managing director Susanne Leonhartsberger said in prepared remarks.
“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.”
“This approval represents a significant milestone in Chiesi’s work to bring Retavase back to the US market,” Alan Roberts, SVP of scientific affairs for Chiesi’s U.S. division, added. “Wacker is a proven leader in microbial technology. The collaborative effort and partnership have been outstanding.”
