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Wacker Biotech Obtains FDA Approval

To manufacture the drug substance in Retavase

By: Betsy Louda

, Contract Pharma

Wacker Biotech GmbH has obtained FDA approval to manufacture the drug substance in Retavase, a thrombolysis medication by Chiesi.

 

Wacker will produce reteplase, the active ingredient in the drug Retavase, and Chiesi will then market it in the USA. 

 

The medication is used to treat acute myocardial infarction in adults. Acute STEMI, also known as acute heart attack, is one of the main causes of death and illness worldwide and, in most cases, stems from a blood clot in a coronary artery.

 

Wacker Biotech has successfully transferred and implemented the entire manufacturing process for reteplase to its GMP plant in Halle/Saale (Germany). It already obtained approval from the European Medicines Agency (EMA) in 2012.

 

“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,” said Dr. Susanne Leonhartsberger, managing director of Wacker Biotech. “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.”

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