Aurobindo Pharma says US FDA inspection at subsidiary ends with 11 procedural observations – CNBC TV18

Aurobindo Pharma Ltd on Friday (February 6) mentioned the USA Meals and Drug Administration (US FDA) has accomplished an inspection at Unit-III of Eugia Pharma Specialities Ltd, its wholly owned subsidiary.(*11*)The US FDA inspected Unit-III, a formulation manufacturing facility situated at Part-III, TSIIC, EPIP, IDA, Pashamylaram, Patancheru Income Mandal, Sangareddy district in Telangana, from January 27 to February 6, 2026.

In line with the corporate’s submitting, the inspection concluded with 11 observations. Aurobindo Pharma mentioned the observations are procedural in nature and can be responded to inside the stipulated time.

Additionally Learn: Aurobindo Pharma arm to purchase extra 20% stake in China JV for $5.1 million(*11*)The corporate said that there is no such thing as a impression on its financials or operations because of the inspection end result. It added that it stays dedicated to sustaining high quality manufacturing requirements throughout its services globally and can preserve the inventory exchanges knowledgeable of any additional developments associated to the matter.

Final yr, Aurobindo Pharma mentioned the USA Meals and Drug Administration (FDA) had accomplished its inspection of Unit-V, an API manufacturing facility of its wholly-owned subsidiary Apitoria Pharma Personal Restricted, in Telangana.(*11*)The inspection was carried out from December 1-12, 2025, at the power situated within the Industrial Growth Space, Chemical Zone, Pashamylaram Village, Patancheru Mandal, Sangareddy District.

(*11*)Additionally Learn: Aurobindo Pharma subsidiary acquires Khandelwal Laboratories’ non-oncology prescription enterprise for ₹325 cr

(*11*)On the conclusion of the inspection, the FDA issued a Type 483, citing three observations, described by the corporate as procedural in nature. Aurobindo Pharma mentioned it would reply to the regulator inside the stipulated timelines.

(*11*)The corporate added that the event doesn’t impression the operations of the power. It reaffirmed its dedication to sustaining the best high quality manufacturing requirements throughout all its world services.

(*11*)Shares of Aurobindo Pharma Ltd ended at ₹1,195.00, up by ₹12.50, or 1.06%, on the BSE.