Impact Analyses - Aurobindo Pharma Receives 8 USFDA observations for Unit XII

β-lactam Antibiotic Facility with Several Market Leading Products

The USFDA conducted an inspection of Aurobindo Pharma’s Unit XII facility located at Sy.No.314 Bachupally, Bachupally Mandal, Medchal-Malkajgiri District, Medchal, Telangana 500090, India (IND) from 25 August and 5 September 2025. At the conclusion of the inspection, the agency issued a Form 483 with eight observations.

1. This facility manufactures several generic products (oral and injectables). All the products belong to the β-lactam class of Antibiotics.
2. Many of the injectable products and some of the oral products are backed up by Eugia’s facility.
3. The site generates sizeable revenue in annual sales. Of these many products are backed up by another facility.
4. Many of the market leading products are backed up by another facility.
5. Being β-lactam antibiotics facility, most products are manufactured through naturally sourced ingredients.

While the observations are yet to be known, the facility is exposed to the risk of contamination as it manufactures several injectable products. Given the higher number of observations, remediation may take longer time with a constant risk of escalation of GMP issues.

In case of any supply disruption (due to remediation/GMP escalation), significant portion of US sales is at stake. A supply disruption would also mean possible drug shortages in some market leading products.