Aurobindo Pharma Limited has announced the successful completion of a US Food and Drug Administration (US FDA) inspection at Unit V of its wholly-owned subsidiary, Apitoria Pharma Private Limited. The inspection was conducted at the company’s Active Pharmaceutical Ingredients (API) manufacturing facility, located in Pashamylaram Village, Patancheru Mandal, Sangareddy District, Telangana, from December 9 to December 17, 2024.
The inspection concluded with two minor procedural observations. Aurobindo Pharma clarified that these observations are procedural in nature and do not involve any critical issues or major non-compliance concerns. The company further stated that the observations will be addressed promptly within the stipulated timeline as per US FDA guidelines.
This development reflects Aurobindo Pharma’s commitment to maintaining the highest standards of quality and compliance across its manufacturing operations. The completion of the inspection with only minor observations highlights the robust systems and processes in place at Apitoria Pharma’s Unit V facility, which plays a significant role in the company’s API production.
Aurobindo Pharma assured stakeholders that it will provide updates to the stock exchanges if any further information related to the inspection becomes available. This successful outcome reinforces the company’s position as a trusted global pharmaceutical manufacturer adhering to international regulatory standards.
The inspection underscores the importance of Unit V in Aurobindo Pharma’s production capabilities, particularly in the API segment, which forms a critical part of its global supply chain.
