Strides Pharma gets zero USFDA observations for Alathur facility

The company's formulation facility at Alathur in Chennai underwent a United States Food and Drug Administration (USFDA) inspection from August 5 to 9, 2019, Strides Pharma Science said in a filing to the BSE.

New Delhi: Drug firm Strides Pharma Science on Friday said its Alathur facility in Chennai has successfully completed inspection by the US health regulator with zero observations.

The company's formulation facility at Alathur in Chennai underwent a United States Food and Drug Administration (USFDA) inspection from August 5 to 9, 2019, Strides Pharma Science said in a filing to the BSE.

The inspection concluded with Zero 483 observations, it added.

"The facility recently completed a significant capacity expansion which will support the growth momentum for the US business and will solve for near-term capacity issues due to the ongoing remediation at the Puducherry facility," it said.

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The Alathur facility became part of the Strides manufacturing base in May 2017, after the company entered into a 50:50 joint venture (JV) with Vivimed Labs, it added.

In March 2019, Strides converted its ownership in JV to 100 per cent to take full management and operational control of this manufacturing facility, Strides Pharma Science said.

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