According to reports from CNBC TV18 and Business Standard, Aurobindo Pharma's wholly owned subsidiary CuraTeQ Biologics Private Limited has received approval from Brazil's health regulator ANVISA for its biosimilars manufacturing facility in Hyderabad. The approval follows a Good Manufacturing Practices (GMP) inspection covering biological active pharmaceutical ingredients (API), sterile products and four biosimilar products. The facility underwent the inspection from May 11 to May 15, 2026, with approval granted after successful completion of the inspection for biological API and sterile products. The submission was made pursuant to Regulation 30 of the SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015, with Company Secretary B. Adi Reddy confirming the development in the regulatory filing.
As reported by CNBC TV18 and Business Standard, the inspection covered four biosimilar products and assessed the company's mammalian and microbial drug substance manufacturing facility. The comprehensive evaluation included the prefillable syringe and vial filling facility, packaging and labelling facility, quality control (QC) testing and release laboratories. 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 scope of the inspection included the facility's biological API and sterile product manufacturing operations, further strengthening the company's regulatory credentials.
According to the regulatory filing, the approval strengthens the company's capability to supply biosimilar products to the Brazilian and broader Latin American markets. As per Business Standard, the ANVISA approval further enhances the company's ability to supply biosimilar products to Brazil and the broader Latin American market. This development provides Aurobindo Pharma with enhanced access to the Brazilian pharmaceutical market through its subsidiary's regulatory-compliant manufacturing capabilities in the region. The approval enables the company to supply the Brazilian and Latin American markets with the four biosimilar products covered under the ANVISA approval.
As reported by CNBC TV18, this approval follows last month's announcement 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. The US FDA inspection was conducted from June 22 to June 26 at the subsidiary's manufacturing facility in Sancham Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh, which manufactures Active Pharmaceutical Ingredients (API) and pharmaceutical formulation intermediates. The US FDA inspection concluded with two observations that the company will address within the stipulated timeline.
According to CNBC TV18 and Business Standard, shares of Aurobindo Pharma Ltd ended at ₹1,570.90, up by ₹10.35, or 0.66%, on the BSE following the regulatory announcement. However, as per Business Standard, the counter slipped 2.65% to ₹1,538.60 on the BSE following the latest regulatory developments. The company stated that there is no impact on its financials or operations arising from the inspection outcome, and remains committed to maintaining high-quality manufacturing standards while keeping stock exchanges informed of any further developments related to regulatory matters. As per latest trading data, shares of Aurobindo Pharma Limited were last trading at ₹1,560.55 on BSE, compared to the previous close of ₹1,534.05, with the stock hitting an intraday high of ₹1,573.90 and low of ₹1,537.60. The total number of shares traded was 42,075 in over 2,125 trades with a net turnover of ₹653.85 crore.
