US FDA raises fresh concerns on Sun Pharma's Halol plant

The US Food and Drugs Administration (USFDA) has found deviations in goods manufacturing practices at Sun Pharmaceutical’s Halol plant — a development which might delay revival of the drug maker’s US business. The Halol plant is a key manufacturing unit for Sun Pharmaceutical, which earns about half its revenue from the US market. Halol contributed in high single digits to the company’s US sales till it was served a warning letter in December 2015. The resolution of quality issues at the plant is thus crucial for the company else it will not be able to receive fresh product approvals from this plant.