Wacker Biotech approved to make API in US

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Credit: Shutterstock.com/ Hywit Dimyadi

Wacker Biotech has picked up US regulatory approval to manufacture reteplase, the active ingredient in Retavase, a thrombosis medication produced by Italian pharma Chiesi.

Originally manufactured by Roche, Retavase is used to treat acute myocardial infarction in adults and recently picked up FDA approval.

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.

Chiesi has acquired the marketing rights for the drug for the USA, among other countries, and worked on obtaining the new approval in close cooperation with WACKER.

Wacker Biotech obtained approval for the commercial manufacture of the active ingredient for the US market a mere three months after the FDA inspection of the plant in Halle.