The United States Food and Drug Administration (USFDA) has concluded inspection at Aurobindo Pharma's wholly owned subsidiary -- Apitoria Pharma's Unit-II, an API manufacturing facility, situated at Gaddapotharam, Industrial Development Area-Kazipally Industrial Area, Jinnaram Mandal, Sangareddy District, Telangana. The inspection concluded with one observation, which is procedural in nature. The inspection was conducted from September 7, 2026 to September 15, 2026.
The company will respond to the US FDA within the stipulated timeline. The company is committed to maintaining robust quality and compliance standards across its manufacturing facilities.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
