Aurobindo Pharma Ltd announced that the US Food and Drug Administration (US FDA) inspection of Unit-IV at its wholly owned subsidiary Apitoria Pharma Private Ltd concluded with zero observations. According to reports from CNBC TV18, the active pharmaceutical ingredient (API) manufacturing facility in Pydibhimavaram, Srikakulam district, Andhra Pradesh was inspected from September 7 to September 11, 2026. The company stated it is committed to maintaining quality and compliance standards across its manufacturing facilities.
The company also received one observation following a recent US FDA inspection at its wholly owned subsidiary Apitoria Pharma in Gaddapotharam, Telangana. As reported by Moneycontrol, the inspection was conducted from September 7 to September 15, 2026 and concluded with one procedural observation. The company has committed to responding to the regulator within the stipulated timeline, demonstrating its proactive approach to regulatory compliance across all subsidiary operations.
Separately, Aurobindo Pharma received final USFDA approval to manufacture and market Beclomethasone Dipropionate HFA Inhalation Aerosol, a generic equivalent of QVAR Inhalation Aerosol. According to Moneycontrol, the approval covers both 40 mcg and 80 mcg strengths, expanding the company's respiratory therapy portfolio. This regulatory milestone adds to the company's growing list of approved products in the US market.
Shares of Aurobindo Pharma Ltd closed at ₹1,664.90, down ₹10.55, or 0.63%, in the previous trading session, as reported by Moneycontrol. The stock is currently trading 2.45% below its 52-week high of ₹1,706.70 and 56.18% above its 52-week low of ₹1,066.00. The company's market capitalisation stands at ₹96,697.66 crore, reflecting investor confidence in its regulatory compliance and manufacturing capabilities across its subsidiary operations.
