Aurobindo Pharma announced that its wholly-owned subsidiary, CuraTeQ Biologics, has received a Good Manufacturing Practice (GMP) certificate of compliance from the European Medicines Agency (EMA) for its biosimilars manufacturing facility located in Hyderabad, India. This certification marks a significant step for Aurobindo as it seeks to expand its presence in the European biosimilars market.
The EMA inspection, which took place from April 8th to April 12th, 2024, involved a comprehensive assessment of CuraTeQ's facility. The evaluation covered key areas including mammalian and microbial drug substance manufacturing, prefilled syringes and vials filling, packaging processes, and quality control (QC) testing and release laboratories. The successful outcome of this inspection confirms that CuraTeQ's facility adheres to the stringent GMP standards required by the EMA.
Satakarni Makkapati, Director and CEO of Biologics, Vaccines, and Peptides at Aurobindo Pharma, emphasized the importance of this achievement, stating that the EU GMP certification underscores CuraTeQ's dedication to producing high-quality biosimilars for patients worldwide. This certification is particularly significant as it paves the way for potential approvals of Aurobindo's biosimilar products currently under review by the EMA. The company anticipates decisions on these biosimilars within the next two to five months, potentially broadening treatment options for patients across Europe.
