Aurobindo Pharma Limited announced that its wholly owned subsidiary, CuraTeQ Biologics Private Limited, has successfully received the Good Manufacturing Practice (GMP) certificate of compliance for its biosimilars manufacturing facility from the European Medicines Agency (EMA). This marks a significant milestone in the company’s ongoing efforts to produce high-quality biosimilars for patients globally.

EMA Inspection and Certification

The GMP certification was granted following a rigorous inspection conducted by EMA representatives from April 8 to April 12, 2024. The inspection assessed multiple sections of the manufacturing facility, including the production of mammalian and microbial drug substances, prefilled syringes and vials filling, packaging processes, as well as quality control (QC) testing and release laboratories.

“The EU GMP certification signifies a major achievement in our commitment to delivering high-quality biosimilars to patients worldwide. This positive inspection outcome sets the stage for securing approvals for our three biosimilars in Europe, which are currently under review by the EMA. We expect these approvals within the next two to five months,” said Dr. Satakarni Makkapati, Director of Aurobindo Pharma and CEO of Biologics, Vaccines, and Peptides.

CuraTeQ’s Vision and Biosimilars Portfolio

CuraTeQ Biologics, based in Hyderabad, India, is a biopharmaceutical company dedicated to developing affordable, high-quality biosimilars for the treatment of various cancers and autoimmune diseases. The company currently has a robust pipeline consisting of fourteen biosimilars, with a primary focus on oncology and immunology.

“Our portfolio of fourteen biosimilars in development underscores our dedication to creating a sustainable range of therapies for patients suffering from chronic and debilitating conditions. With this certification, we are one step closer to offering critical treatment options in oncology and immunology across global markets,” said K. Nithyananda Reddy, Vice-Chairman and Managing Director of Aurobindo Pharma Limited.

End-to-End Manufacturing Capabilities

CuraTeQ’s manufacturing facility is equipped with end-to-end capabilities that allow the company to handle the entire biosimilar production process. This includes everything from the production of bulk drug substances to fill-finish and final packaged drug products. This comprehensive approach ensures that CuraTeQ is well-positioned to meet the growing global demand for high-quality, cost-effective biosimilars.

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Future Growth and Global Impact

With the EU GMP certification, CuraTeQ is poised to expand its reach in European markets and beyond, offering affordable biosimilar treatments for patients suffering from critical conditions. As the company continues to advance its R&D efforts, it is committed to making life-saving therapies more accessible to patients globally, especially in emerging markets where treatment options are often limited.

This certification further strengthens CuraTeQ’s position as a leading player in the biosimilars space, paving the way for the company to deliver on its vision of improving the lives of patients with serious health conditions worldwide.

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