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Release testing for Grasustek at VelaLabs

Jun 17, 2019

May 2019: VelaLabs authorized for release testing of Grasustek  Biosimilar in Europe

 

In April 26, 2019, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use recommended the granting of a marketing authorization for the pegfilgrastim biosimilar Grasustek.  Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) filgrastim. Grasustek was developed by the Indian company USV Ltd. and the application for its approval was submitted to EMA by USV subsidiary Juta Pharma, Germany. USV, as a long-term client of VelaLabs, has authorized us for handling the release testing package of the product.

https://www.ema.europa.eu/en/medicines/human/summaries-opinion/grasustek

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