Aurobindo Pharma unit secures Brazil ANVISA approval for facility
CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma, secured ANVISA approval for its biosimilars manufacturing facility in Hyderabad after a successful GMP inspection from May 11 to May 15, 2026. The approval covers biological API and sterile products, including four specific biosimilar products, and strengthens the company's market reach in Brazil and Latin America.

*this image is generated using AI for illustrative purposes only.
CuraTeQ Biologics Private Limited, a wholly owned subsidiary of aurobindo pharma , has received approval from ANVISA, the National Health Surveillance Agency of Brazil, for its biosimilars manufacturing facility in Hyderabad. The approval was granted following a successful GMP inspection conducted from May 11 to May 15, 2026. This regulatory endorsement strengthens the company's capability to supply biosimilar products to the Brazilian and broader Latin American markets.
The inspection assessed the facility's compliance for biological API and sterile products. The scope covered four biosimilar products and evaluated the mammalian and microbial drug substance manufacturing facility, prefillable syringe and vial filling facility, packaging and labelling facility, and QC testing and release laboratories.
CuraTeQ's drug substance and drug product GMP facility is already certified by the European Medicines Agency (EMA) and the World Health Organization (WHO). The ANVISA approval reaffirms CuraTeQ Biologics' commitment to global regulatory compliance and quality standards.
Inspection Details
| Inspection Aspect | Details |
|---|---|
| Regulatory Authority | ANVISA (Agência Nacional de Vigilância Sanitária) |
| Inspection Dates | May 11 to May 15, 2026 |
| Facility Location | Hyderabad |
| Scope | Biological API and sterile products |
| Products Covered | Four biosimilar products |
The submission was made pursuant to Regulation 30 of the SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015. B. Adi Reddy, Company Secretary of Aurobindo Pharma Limited, confirmed the development in the filing.
Historical Stock Returns for Aurobindo Pharma
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| +0.56% | -1.06% | -0.14% | +35.28% | +37.10% | +58.97% |
What is the projected timeline for the commercial launch of the four biosimilar products in the Brazilian market?
How will this ANVISA approval impact Aurobindo Pharma’s revenue growth in the Latin American region over the next fiscal year?
Are there plans to seek similar regulatory approvals for this facility in other key global markets to further expand export capabilities?


































