Express Pharma

Strides Shasun maintains ‘Zero 483’ Status


Three facilities were inspected by US FDA and were cleared with Zero 483 Status in the last one month

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. These include API facility at Cuddalore from April 17, 2017 to April 21, 2017; Oral Dosage facility at Puducherry from April 24, 2017 to April 28, 2017 and API facility at Puducherry from May 1, 2017 to May 5, 2017.

With this, the company’s last four US FDA inspections were completed without any observations.

Commenting on the development, Shashank Sinha, Group CEO, Strides Shasun stated, “We are delighted with the outcome of the recent USFDA inspection at three of our main facilities.”

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