USFDA completes inspection of Strides Pharma's Alathur facility with zero observations
"This is the second consecutive Zero 483 inspection for the site," Strides Pharma Science said in a filing to the BSE.
The company's formulation facility at Alathur underwent a United States Food and Drug Administration (USFDA) inspection which concluded with 'Zero 483 observations', it added.
The current inspection was a pre-approval inspection for sustained release class of drugs which is a new dosage format for the facility and is one of the focus areas for the company in the global market, the company said.
The facility recently completed a significant capacity expansion which will support the growth momentum for the US business, it added.
In a separate filing, Strides Pharma Science said its step-down wholly owned subsidiary, Strides Pharma Global Pte Ltd Singapore, has received tentative approval for Triamcinolone Acetonide ointment USP, 0.05 per cent from the USFDA.
The product will be manufactured at the company's oral dosage facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market, it added.
The final approval for Strides will be effective May 30, 2020 when the company will launch the product, it said.
According to IQVIA MAT data, the US market for Triamcinolone Acetonide Ointment USP, 0.05 per cent is around USD 20 million (about Rs 142 crore), it added.
Shares of Strides Pharma Science Ltd on Friday closed 0.61 per cent higher at Rs 414.75 per scrip on the BSE. AKT RVK