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Business EconomyPosted at: Nov 12 2024 9:49PM


CuraTeQ Biologics gets GMP certificate of compliance for its facility in Hyderabad from EMA

Hyderabad, Nov12 (UNI) CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, has received a GMP certificate of compliance for its biosimilars manufacturing facility in Hyderabad from the European Medicines Agency (EMA)
The GMP inspection, conducted by EMA representatives from April 8 to April 12, 2024, assessed mammalian and microbial drug substance manufacturing facility sections, prefilled syringes and vials filling, packaging, and QC testing and release laboratories, the Hyderabad-based pharma company said in a release here on Tuesday..
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 the 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, said "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.”
Focusing on developing biosimilars for the treatment of various cancers and autoimmune diseases, CuraTeQ's pipeline consists of fourteen biosimilars, primarily targeting the immunology and oncology segments.
It has end-to-end capabilities in producing a full range of products from bulk drug substance to fill-finish and packaged drug products.
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