Key Development
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.
Inspection Details
The facility underwent a Good Manufacturing Practice (GMP) inspection by ANVISA from May 11 to May 15, 2026. The approval was granted following successful completion of the inspection for biological API and sterile products. The scope of the GMP inspection covered four biosimilar products and assessed:
- Mammalian and microbial drug substance manufacturing facility
- Prefillable syringe and vial filling facility
- Packaging and labelling facility
- QC testing and release laboratories
Existing Certifications
CuraTeQ's drug substance and drug product GMP facility is already certified by:
- EMA (European Medicines Agency)
- WHO (World Health Organization)
Strategic Implications
The ANVISA approval reaffirms CuraTeQ Biologics' commitment to global regulatory compliance and quality standards. The approval strengthens the Company's capability to supply biosimilar products to the Brazilian market and broader Latin American markets.
Filing Details
Submitted to: National Stock Exchange of India Limited (Scrip Code: AUROPHARMA) and BSE Limited (Company Code: 524804)