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CuraTeQ Biologics Secures ANVISA Approval for Hyderabad Biosimilars Manufacturing Facility

CuraTeQ Biologics Secures ANVISA Approval for Hyderabad Biosimilars Manufacturing Facility

CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has received Good Manufacturing Practices (GMP) approval from Brazil's National Health Surveillance Agency (ANVISA) for its biosimilars manufacturing facility in Hyderabad.

The approval follows a successful GMP inspection conducted by ANVISA between May 11 and May 15, 2026, covering the facility's manufacturing operations for biological Active Pharmaceutical Ingredients (APIs) and sterile products.

The regulatory inspection evaluated multiple aspects of CuraTeQ's manufacturing capabilities, including the mammalian and microbial drug substance production facility, prefilled syringe and vial filling operations, packaging and labelling units, as well as quality control testing and product release laboratories. The inspection also covered four biosimilar products manufactured at the site.

With the latest approval, CuraTeQ strengthens its global regulatory credentials and enhances its ability to supply high-quality biosimilar products to Brazil, one of Latin America's largest pharmaceutical markets, while supporting expansion across the broader region.

The Hyderabad manufacturing facility already holds certifications from the European Medicines Agency (EMA) and the World Health Organisation (WHO). The addition of ANVISA approval further demonstrates the company's adherence to internationally recognised quality, safety and manufacturing standards.

The certification is expected to support CuraTeQ's international growth strategy by expanding market access for its biosimilar portfolio and reinforcing its commitment to delivering globally compliant biologic medicines to patients across regulated markets.

 

More news about: quality / gmp | Published by News Bureau | July - 22 - 2026

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