Strides Pharma's Puducherry Facility Can Seek Fresh Approvals As U.S. FDA Upgrades Status
This is positive news for the company, as the facility's status was modified from official action indicated.
Strides Pharma Science Ltd. said its Puducherry facility has been upgraded to a status that will allow it to seek fresh approvals in the U.S.
The U.S. Food and Drug Administration modified the facility to "voluntary action indicated" from "official action indicated" after an inspection conducted from February 20–24, according to its filing.
A voluntary action means that while investigators find and document objectionable conditions, the FDA will not take or recommend regulatory or enforcement action. Official action classification indicates that the U.S. drug regulator would suggest corrective actions and may withhold approvals of pending product applications till observations are resolved.
The U.S. drug regulator recommended official action in May 2019, followed by a warning letter in July 2019 for the unit.
The Puducherry facility caters to the U.S., other regulated markets, and institutional businesses and produces finished dosage formulation products across multiple dosage formats.
"Consequent to this reclassification by the U.S. FDA, the filed ANDAs from this facility will now start receiving approvals," the company said in the filing.
Shares of the company were trading 0.7% higher compared to a 0.21% decline in the benchmark Sensex as of 10:24 a.m.