Aurobindo Pharma gets zero observations from US FDA inspection at Andhra Pradesh facility

Aurobindo Pharma arm Apitoria to acquire 80% stake in A1 Biochem Group for $17 million


Drug firm Aurobindo Pharma Ltd on Friday (September 11) said the US Food and Drug Administration (US FDA) inspection at Unit-IV of Apitoria Pharma Private Ltd, its wholly owned subsidiary, concluded with zero observations on Friday (September 11).

The US FDA inspected the active pharmaceutical ingredient (API) manufacturing facility at Pydibhimavaram, Srikakulam district, Andhra Pradesh, from September 7 to September 11, 2026.

The company said the inspection concluded with zero observations. Aurobindo Pharma said it is committed to maintaining quality and compliance standards across its manufacturing facilities.

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Last month, Aurobindo Pharma Ltd said a routine US Food and Drug Administration (US FDA) inspection at its subsidiary AuroPeptides Ltd concluded with one observation.

The inspection was conducted from August 17 to August 21, 2026, at AuroPeptides’ manufacturing facility in Indrakaran Village, Kandi Mandal, Sangareddy District, Telangana. The facility manufactures peptide Active Pharmaceutical Ingredients (APIs).

“The United States Food and Drug Administration (US FDA) conducted a routine inspection at AuroPeptides Ltd, a manufacturer of Peptide APIs, located at Indrakaran Village, Kandi Mandal, Sangareddy District, Telangana – 502329, from 17th to 21st August, 2026,” according to a stock exchange filing.

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According to Aurobindo Pharma, the sole observation related to facility and equipment maintenance. The company said the observation does not pertain to data integrity or related Good Manufacturing Practices (GMP) compliance.

Aurobindo Pharma also said corrective action had already been initiated during the course of the inspection. The company will submit its formal response within the stipulated timeline.

Shares of Aurobindo Pharma Ltd ended at ₹1,675.45, up by ₹6.45, or 0.39%, on the BSE.

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