FDA Grants Wacker OK to Manufacture Biologic API

By Akia Thorpe -

January 10, 2018

Wacker Biotech, a Jena, Germany-headquartered contract manufacturer of biopharmaceutical proteins, has transferred the production process of Retavase (reteplase), a thrombolytic drug, to its Halle/Saale, Germany plant.

Chiesi, a Parma, Italy-based pharmaceutical firm, acquired the marketing rights for Retavase in the US and other countries, from the original manufacturer, Roche, and worked on obtaining the new approval in cooperation with Wacker. Along with transferring the manufacturing process for the drug to its facility, Wacker covered the validation of the analytical methods for process control and release testing for the drug. Wacker also established the supply of the drug for Chiesi's relaunch of Retavase in the US market.

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

Source: Wacker Biotech