This site is intended for healthcare professionals only
LoginRegister

Aurobindo Pharma arm gets GMP certificate of compliance for biosimilars manufacturing facility from EMA

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli   |  
Aurobindo Pharma arm gets marketing authorisation for Zefylti in EU
  • whatsapp
  • Telegram

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

CuraTeQ Biologics Private Limited (CuraTeQ), a subsidiary of Aurobindo Pharma Limited, is a global 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

curateq biologicsaurobindo pharmaaurobindo pharma news
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

    Show Full Article
    Next Story
    X