Aurobindo Pharma Subsidiary's Biosimilars Facility Gets ANVISA Approval
Aurobindo Pharma's subsidiary, CuraTeQ Biologics, received ANVISA approval for its biosimilars manufacturing facility in Hyderabad. The approval follows a successful GMP inspection covering API and sterile product manufacturing, strengthening the company's position in Latin American markets.
The approval opens up new markets (Brazil and Latin America) for biosimilar products, which is significant for future revenue growth, but it does not immediately translate to substantial financial gains.
The ANVISA approval for the biosimilars manufacturing facility is a positive development, enhancing the company's market access and regulatory compliance.
CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, has received approval from ANVISA (Agência Nacional de Vigilância Sanitária), the National Health Surveillance Agency of Brazil, for its biosimilars manufacturing facility located in Hyderabad.
The facility was inspected by ANVISA for Good Manufacturing Practices (GMP) from May 11 to May 15, 2026. The approval was granted after the successful completion of the inspection, which covered the manufacturing of biological active pharmaceutical ingredients (API) and sterile products.
The scope of the GMP inspection included four biosimilar products and assessed the mammalian and microbial drug substance manufacturing capabilities, as well as prefillable syringe and vial filling, packaging and labelling, and quality control testing and release laboratories. This approval adds to CuraTeQ's existing EMA and WHO certifications, reinforcing its adherence to global regulatory compliance and quality standards. The ANVISA approval is expected to enhance the company's ability to supply biosimilar products to the Brazilian and wider Latin American markets.
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