Hyderabad, January 28, 2025 – Aurobindo Pharma Limited (BSE: 524804, NSE: AUROPHARMA) has announced that its wholly owned subsidiary, Apitoria Pharma Private Limited, has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Unit-2 API manufacturing facility in Telangana.
Key Highlights
Inspection Details:
The facility, located in Gaddapotharam Village, Jinnaram Mandal, Sanga Reddy District, Telangana, was inspected by the US FDA from September 23 to 27, 2024.
Classification:
The US FDA classified the facility as Voluntary Action Indicated (VAI), signifying that the inspection did not identify any significant violations that could adversely impact public health.
Significance of the EIR
The VAI classification reinforces the facility’s compliance with regulatory standards and positions Aurobindo Pharma to continue its operations and expand its presence in the US pharmaceutical market. The facility is critical for producing Active Pharmaceutical Ingredients (APIs), which are integral to the company’s supply chain for domestic and international markets.
Management Commentary
Aurobindo Pharma emphasized that the EIR reflects its commitment to quality and regulatory compliance. This milestone is expected to bolster the company’s reputation and strengthen its ability to cater to the growing demand for APIs globally.