Granules API, formulations facility in Vizag completes U.S. FDA inspection

Granules India’s Unit V facility in Visakhapatnam that manufactures APIs and formulations of oncology and non-oncology products | Photo Credit: Special arrangement

Drugmaker Granules India’s Unit V manufacturing facility in Visakhapatnam has completed an U.S. Food and Drug Administration inspection.

It was a pre-approval inspection (PAI) and cGMP audit for APIs and formulations for oncology and non-oncology products. The unit successfully completed the U.S. FDA inspection, conducted from April 8-12, resulting in zero Form 483 observations, the company said. “Proud to reiterate that our focus on high-quality standards is comparable to the best global benchmarks as we receive zero observations from U.S. FDA audit,” CMD Krishna Prasad Chigurupati said in a release on Saturday.