Impact Analyses: Aurobindo Unit 7 Observations Put 9 Drugs At Risk of Shortages

Aurobindo Pharma received 9 USFDA observations for its Unit VII facility. The facility is not only important for Aurobindo, but also important for certain products where Aurobindo commands highest market share.

 •                     Product Profile: Total 209 products are manufactured at this facility; 6 are currently discontinued and 2 are branded drugs. Additionally, quite of few of these products have backup manufacturing facilities.

•                   Revenue Contribution: The facility contributes ~51% of Aurobindo’s total US sales*, making it a strategically critical site for the company’s US generics portfolio.

•                  Regulatory Context: Issuance of 9 Form 483 observations indicates compliance gaps requiring remediation; final FDA classification (NAI/VAI/OAI) is pending. Prior NAI status on 08-04-2023 suggests historically acceptable compliance standards.

•                  Products Likely Exposed to Shortages: (Based on Market Share >25%, No Backup manufacturing and Sales* >$3Mn): We have identified 9 products that are exposed to possible shortages, in the event of escalation of GMP issues.

•                  Financial Impact: While facility concentration is high, strong backup manufacturing coverage reduces consolidated revenue risk; however, compound-level exposure could be meaningful in high-market-share products lacking alternate supply.

 We offer you a deep dive into every product manufactured in the facility to gauge the impact of this development on the generic market along with Aurobindo.