Apitoria Pharma completes USFDA inspection in September
Key Highlights
The facility has been classified as Voluntary Action Indicated (VAI) by the USFDA
Aurobindo Pharma subsidiary Apitoria Pharma received an Establishment Inspection Report from the US Food and Drug Administration for its Telangana manufacturing unit. The regulator classified the facility as Voluntary Action Indicated following an inspection conducted in September 2026.
The USFDA inspection of the Unit-II API manufacturing facility took place between September 7, 2026, and September 15, 2026. This site is situated in the Gaddapotharam area of the Sangareddy District in Telangana. The classification indicates that the agency identified certain conditions that require corrective actions, though these do not necessitate immediate regulatory intervention.
Aurobindo Pharma operates this facility through its wholly owned subsidiary, Apitoria Pharma. The company manufactures various pharmaceutical products at its sites, including active pharmaceutical ingredients, intermediates, and generic formulations. Its product portfolio covers segments such as anti-infectives, oral and sterile antibiotics, pain management, and osteoporosis treatments. The company produces items like astemizole, domeperidone, and omeprazole.
Based on company and agency reports. For information only; not investment advice.