Sun Pharma’s Dadra unit tagged ‘OAI’ by US FDA

(20 second reading) Regulatory troubles continue for Sun Pharma as the drug manufacturer’s Mumbai unit has been issued an “official action indicated” (OAI) tag by the US Food and Drug Administration, which may affect new launches.
The OAI classification for Sun’s Dadra unit follows recent regulatory trouble for Halol and Mohali facilities in the recent past, which had an impact on Sun Pharma’s generic sales.
HSBC expects the drugmaker’s US generic sales, excluding cancer drug Revlimid, to remain range-bound due to regulatory issues.
Analysts at HSBC expect the FDA move to add to the regulatory overhang for the drugmaker, while those at Nomura see it as a negative surprise.