The US FDA is expected to begin a critical re-inspection of Sun Pharma’s manufacturing facility at Halol in the second week of February, according to Economic Times’ sources.
In December of 2015, Sun Pharma received an FDA warning letter citing serious sterility concerns at its manufacturing site in Halol, India. A year later, the FDA hits the drugmaker with a 14-page notice over additional Halol plant concerns.
After years of delays, Sun Pharma said it has completed the remediation exercise at Halol and requested a re-inspection. The inspection is critical for the drugmaker, as the Halol site, when fully operational, contributes as much as 15 percent of Sun Pharma's U.S. revenues.