U.S. FDA Completes Inspection Of Strides Pharma’s Unit With Zero Observations
Drug firm Strides Pharma Science Ltd. on Friday said the U.S. health regulator has completed inspection of its Alathur facility in Tamil Nadu 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 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 U.S. 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 percent from the U.S. FDA.
The product will be manufactured at the company's oral dosage facility at Bengaluru and will be marketed by Strides Pharma Inc in the U.S. 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 percent is around $20 million (about Rs 142 crore), it added.
Shares of Strides Pharma Science on Friday closed 0.61 percent higher at Rs 414.75 per scrip on the BSE.