Aurobindo Pharma arm gets GMP certificate of compliance for biosimilars manufacturing facility from EMA
Hyderabad: CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, has received a
GMP certificate of compliance for its biosimilars manufacturing facility from the EMA. The GMP inspection,
conducted by EMA representatives from April 8th to April 12th, 2024, assessed mammalian and microbial drug
substance manufacturing facility sections, prefilled syringes and vials filling, packaging, and QC testing and
release laboratories
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 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, added, “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.”
Read also: Aurobindo Pharma arm announces successful Phase 1 clinical study outcome of their BP11 product
biopharmaceutical company headquartered in Hyderabad, India. It is focused 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 fillfinish and packaged drug products.
Read also: Aurobindo Pharma unit partners with MSD to foray into contract manufacturing operations
