Aurobindo Pharma Limited has announced the conclusion of a US FDA inspection at Unit-II of its wholly owned subsidiary, Apitoria Pharma Private Limited. The inspection, conducted at the API manufacturing facility in Telangana, resulted in a single procedural observation. Aurobindo has stated its commitment to maintaining high quality standards and will respond to the FDA within the stipulated timeline. The company will provide further updates as required.
US FDA Inspection of Apitoria Pharma Unit-II Concludes
Aurobindo Pharma Limited has officially notified stakeholders regarding the completion of an inspection by the United States Food and Drug Administration (US FDA) at the Unit-II facility. This unit is a key Active Pharmaceutical Ingredient (API) manufacturing site operated by Apitoria Pharma Private Limited, a wholly owned subsidiary of Aurobindo Pharma.
Inspection Details and Outcome
The inspection took place from September 7, 2026, to September 15, 2026. The facility is located at Gaddapotharam, Industrial Development Area – Kazipally Industrial Area, Jinnaram Mandal, Sangareddy District, Telangana. Following the inspection, a single observation was noted, which Aurobindo Pharma has characterized as procedural in nature. The company is committed to addressing this observation and will submit its response to the US FDA within the mandated timeframe.
Commitment to Quality and Compliance
Aurobindo Pharma reiterated its dedication to upholding robust quality and compliance standards across all its manufacturing operations. The company will continue to keep the stock exchanges informed of any material developments concerning this matter, as per regulatory requirements.
Source: BSE
