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CuraTeQ biologics gains EMA GMP certification for biosimilars facility
Industry News- Nov 13,24
The certification followed an inspection by EMA representatives , which evaluated key areas of the facility.
CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, has received a Good Manufacturing Practice (GMP) certification from the European Medicines Agency (EMA) for its biosimilars manufacturing facility. The certification followed an inspection by EMA representatives from April 8-12, which evaluated key areas of the facility, including the mammalian and microbial drug substance manufacturing sections, prefilled syringe and vial filling operations, as well as packaging, quality control testing, and release labs.
This successful certification paves the way for the approval of three biosimilars currently under EMA review, anticipated within the next two to five months, according to Satakarni Makkapati, Director and CEO-Biologics, Vaccines, and Peptides, Aurobindo Pharma. K Nithyananda Reddy, Vice-Chairman and Managing Director, noted the company's commitment to developing a robust biosimilars portfolio, with 14 biosimilars in the pipeline targeting therapeutic areas in oncology and immunology, as part of its mission to make essential treatments more accessible to patients.
(The Hindu)
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