Aurobindo Pharma arm gets GMP certificate of compliance for biosimilars manufacturing facility from EMA

Hyderabad: CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, has received a GMP certificate of compliance for its biosimilars manufacturing facility from the EMA. The GMP inspection, conducted by EMA representatives from April 8th to April 12th, 2024, assessed mammalian and microbial drug substance manufacturing facility sections, prefilled syringes and vials filling, packaging, and QC testing and release laboratories

Dr. Satakarni Makkapati, Director of Aurobindo Pharma Limited and CEO of Biologics, Vaccines, and Peptides, stated, "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."

K. Nithyananda Reddy, Vice-Chairman and Managing Director of Aurobindo Pharma Limited, added, "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.”

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