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US FDA renews approval for Strides Shasun's Puducherry APIs plant

With this, its last four US FDA inspections were successfully completed without any observations

Shasun's formulation facility in Puducherry
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BS B2B Bureau Bengaluru
Last Updated : May 05 2017 | 6:09 PM IST
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The US Food & Drug Administration (FDA) has renewed approval for Strides Shasun's active pharmaceutical ingredients (APIs) manufacturing site in Puducherry.

Over the last month, the company’s three facilities - APIs facility at Cuddalore, oral dosage facility at Puducherry, and APIs facility at Puducherry - were inspected by US FDA and cleared with zero 483 status. The company's flagship facility at KRSG Gardens in Bengaluru was also inspected and cleared by US FDA in June 2016 without any observations.

"We are delighted with the outcome of the recent US FDA inspection 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,” commented Shashank Sinha, group CEO, Strides Shasun.

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First Published: May 05 2017 | 6:03 PM IST

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