Aurobindo Pharma Director and CEO of Biologics, Vaccines and Peptides Satakarni Makkapati said “This inspection outcome paves way for securing approvals for three biosimilars in Europe, currently under review by the Agency, within the next two to five months.”
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Aurobindo Pharma subsidiary CuraTeQ Biologics has received a GMP certificate of compliance for its biosimilars manufacturing facility from the European Medicines Agency (EMA).
The GMP inspection, conducted by EMA representatives from April 8-12, assessed mammalian and microbial drug substance manufacturing facility sections, prefilled syringes and vials filling, packaging and QC testing and release laboratories.
This inspection outcome paves way for securing approvals for three biosimilars in Europe, currently under review by the Agency, within the next two to five months, Aurobindo Pharma Director and CEO of Biologics, Vaccines and Peptides Satakarni Makkapati said in a release on Tuesday (November 12, 2024).
“Our portfolio comprises 14 biosimilars in development across oncology and immunology segments. We are dedicated to building a sustainable biosimilars portfolio and bringing these essential therapies to patients,” Vice-Chairman and Managing Director of Aurobindo Pharma K. Nithyananda Reddy said.
Published – November 12, 2024 06:17 pm IST
