CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has secured a Good Manufacturing Practice (GMP) certificate of compliance from the European Medicines Agency (EMA) for its biosimilars manufacturing facility.
The certification follows an EMA inspection conducted from April 8–12, 2024, marking a significant advancement for CuraTeQ in its efforts to provide high-quality biosimilars worldwide.
Comprehensive GMP Inspection
During the inspection, EMA representatives evaluated multiple aspects of CuraTeQ’s facility, including its mammalian and microbial drug substance manufacturing sections.
Additionally, they assessed the facility’s capabilities in the filling of prefilled syringes and vials, packaging processes, as well as its quality control testing and release laboratories.
The successful completion of these evaluations led to the certification.
European Market Approvals
Satakarni Makkapati, Director of Aurobindo Pharma and CEO of Biologics, Vaccines, and Peptides mentioned, “The EU GMP certification marks a significant step in CuraTeQ’s commitment to manufacturing high-quality biosimilars for patients worldwide.”
He noted that the certification will expedite the review process for three biosimilars currently under assessment by the EMA. He also mentioned that potential approval is expected in the coming two to five months.
Expanding Biosimilars Portfolio
Aurobindo Pharma’s Vice-Chairman and Managing Director, K. Nithyananda Reddy, highlighted the company’s robust portfolio of biosimilars under development. He stated, “Our portfolio includes fourteen biosimilars across oncology and immunology. Our goal is to meet patient needs globally.”
Thehindubusinessline.com reported that with the EU GMP certification in hand, CuraTeQ Biologics can advance its products in the European market. It reflects Aurobindo Pharma’s ongoing commitment to innovative and accessible biosimilar therapies.
