New Indian API facility scrapes through US FDA inspection

Following an inspection from the US medicines regulator, a manufacturing site run by Indian active pharmaceutical ingredient (API) specialist Aparna Pharmaceuticals has received a VAI classification.

The result indicates that FDA investigators discovered “objectionable conditions” during the inspection, but that these are below the threshold of severity for enforcement action to take place.

Based in Hyderabad, Aparna manufactures advanced drug intermediates and APIs, and aims to be the preferred partner for pharmaceutical companies worldwide, by assuring “the highest benchmarks of quality, dependability, innovation, and regulatory compliance.”