“…this is to inform you that 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 in Hyderabad,” according to a stock exchange filing.
The facility underwent a Good Manufacturing Practices (GMP) inspection by ANVISA from May 11 to May 15, 2026. The approval was granted after the successful completion of the inspection for biological API and sterile products.
The scope of the inspection covered four biosimilar products and assessed the company’s mammalian and microbial drug substance manufacturing facility. The inspection also covered the prefillable syringe and vial filling facility, packaging and labelling facility, quality control (QC) testing and release laboratories.
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CuraTeQ’s drug substance and drug product GMP facility is already EMA (European Medicines Agency) and WHO certified, and 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 and broader Latin American markets.
Last month, Aurobindo Pharma informed stock exchanges that the United States Food and Drug Administration (US FDA) has completed an inspection at Auroactive Pharma Private Limited, a wholly owned subsidiary of the company.
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According to the regulatory filing, the inspection was conducted at the subsidiary’s manufacturing facility located in Sancham Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh, from June 22 to June 26.
The facility manufactures Active Pharmaceutical Ingredients (API) and pharmaceutical formulation intermediates.
The company stated that the inspection concluded with two observations. Aurobindo Pharma said the observations would be addressed and responded to within the stipulated timeline. In its disclosure, the company added that there is no impact on its financials or operations arising from the inspection outcome.
Aurobindo Pharma said it remains committed to maintaining high-quality manufacturing standards and would keep the stock exchanges informed of any further developments related to the matter.
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Shares of Aurobindo Pharma Ltd ended at ₹1,570.90, up by ₹10.35, or 0.66%, on the BSE.
