Strides Shasun announced that its active pharmaceutical ingredients (API) manufacturing site in Puducherry was recently inspected by US FDA and the approval was renewed with ‘zero 483’ status.

Over the last month, three facilities were inspected by US FDA and cleared with zero 483 status.
 
While the API facility at Cuddalore was audited between April 17 and 21, 2017, the oral dosage facility inspection was from April 24 to 28, and the API unit at Puducherry was from May 1 to 5 2017.
 
The company’s flagship facility at the KRSG Gardens in Bengaluru was also inspected and cleared by US FDA in June 2016 with zero 483 observations.
 
With this, the company’s last four US FDA inspections were successfully completed without any observations.
 
Commenting on the development, Shashank Sinha, group CEO of Strides Shasun stated, “We are delighted with the outcome of the recent US FDA inspections at three of our main facilities. This is a strong endorsement of our significant investment and ongoing focus on compliance integrity. We remain committed to meet and exceed the expectation of the authorities in the challenging regulatory landscape as it continues to evolve”.