CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has received a Good Manufacturing Practice (GMP) certificate of compliance for its biosimilars manufacturing facility from the EMA.
The GMP inspection, conducted by EMA representatives from April 8-12, 2024, assessed mammalian and microbial drug substance manufacturing facility sections, prefilled syringes and vials filling, packaging, and Quality Control testing and release laboratories.
“The EU GMP certification marks a significant milestone in CuraTeQ’s commitment to manufacturing high-quality biosimilars for patients worldwide. This inspection outcome paves way for securing approvals for our three biosimilars in Europe, currently under review by the Agency, within the next two to five months,’‘ Satakarni Makkapati, Director, Aurobindo Pharma and CEO of Biologics, Vaccines, and Peptides said in a release.
K Nithyananda Reddy, Vice-Chairman and Managing Director of Aurobindo Pharma said, “Our portfolio comprises fourteen biosimilars in development across oncology and immunology segments. We are dedicated to building a sustainable biosimilars portfolio and bringing these essential therapies to patients.”