Sun Pharmaceutical Industries Ltd said the US Food and Drug Administration (FDA) has cleared its Halol drug plant. This should come as a big relief to the country's largest drug maker as the Halol unit had been under supply restrictions due to quality control failures.
The development means that Sun Pharma can resume supplies to the US market from that plant. In 2014, the US drug regulator had first issued Form 483 with more than 20 observations on the plant. This was followed by a warning letter in December 2015 over the violation of manufacturing norms. This resulted in Sun Pharma not being able to export new drugs from the facility. In February, the US FDA had commenced re-inspection of the facility, following which it had issued only three observations.
For Sun Pharma, the unit is important as, at one stage, it contributed more than 15 per cent of the US revenues. In a filing with stock exchanges, Sun Pharma said it had received the establishment inspection report (EIR) from the US FDA for the Halol facility in Gujarat. This came after an inspection conducted by the regulator between February 12-23.
"The agency concluded that the inspection is now closed and the issues contained in the warning letter issued in December 2015 have been addressed," Sun Pharma said.
Sun Pharma managing director Dilip Shanghvi said, "This is an important development for Sun Pharma. We remain committed to following the highest levels of quality at all our manufacturing facilities globally''.