Wacker Biotech GmbH said that it will produce the drug substance reteplase, the active ingredient in the drug Retavase, which the pharmaceutical company Chiesi will market in the US.
The product recently obtained approval from the US Food and Drug Administration (FDA). The medication is used to treat acute myocardial infarction in adults. 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.
In agreement with the original manufacturer of the medication – Swiss pharmaceutical company Roche – Wacker Biotech successfully transferred the production process of the drug substance reteplase to its Halle/Saale plant.
Chiesi has acquired the marketing rights for the drug for the US, among other countries, and worked on obtaining the new approval in close cooperation with Wacker. Not only did Wacker successfully transfer the entire manufacturing process for the complex biopharmaceutical to its facility, it also covered the validation of the analytical methods for process control and release testing of the drug substance. In close cooperation with customer Chiesi, Wacker established the supply of this high-quality drug substance for Chiesi's relaunch of Retavase in US market.
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