CuraTeQ Biologics Secures EMA GMP Certification for Biosimilars Manufacturing
核心洞察
CuraTeQ Biologics (搜索), an Aurobindo Pharma subsidiary, has received EMA GMP certification for its biosimilars (搜索) manufacturing facility, following a comprehensive inspection in April 2024.
The certification covers mammalian and microbial drug substance manufacturing, prefilled syringes and vials filling, packaging, and quality control testing.
This approval is expected to expedite the EMA review process for three biosimilars (搜索), with potential market approvals anticipated within the next two to five months.
CuraTeQ Biologics (搜索), a wholly-owned subsidiary of Aurobindo Pharma, has been granted a Good Manufacturing Practice (GMP) certificate of compliance from the European Medicines Agency (EMA) for its biosimilars (搜索) manufacturing facility. This certification marks a significant milestone for CuraTeQ in its mission to deliver high-quality biosimilars worldwide.
The EMA conducted a thorough inspection of CuraTeQ’s facility from April 8–12, 2024. The evaluation encompassed various critical aspects of the manufacturing process, including the production of mammalian and microbial drug substances, the filling of prefilled syringes and vials, packaging procedures, and the facility's quality control testing and release laboratories. The successful completion of this inspection led to the GMP certification.
"The EU GMP certification marks a significant step in CuraTeQ’s commitment to manufacturing high-quality biosimilars (搜索) for patients worldwide," stated Satakarni Makkapati, Director of Aurobindo Pharma and CEO of Biologics, Vaccines, and Peptides. He also noted that this certification is expected to accelerate the review process for three biosimilars currently under evaluation by the EMA, with potential approvals anticipated in the coming two to five months.
Aurobindo Pharma is actively developing a robust portfolio of biosimilars (搜索). K. Nithyananda Reddy, Vice-Chairman and Managing Director of Aurobindo Pharma, highlighted that the company’s portfolio includes fourteen biosimilars targeting oncology (搜索) and immunology (搜索). "Our goal is to meet patient needs globally," Reddy stated, emphasizing the company's commitment to providing accessible and innovative biosimilar therapies.
With the EU GMP certification, CuraTeQ Biologics (搜索) is now positioned to advance its biosimilar products in the European market, reinforcing Aurobindo Pharma’s dedication to delivering innovative and accessible biosimilar treatments.