Two Strides ANDAs receive USFDA acceptance

The US drug regulator has granted Strides’ request to designate the medications under these ANDAs as a Competitive Generic Therapy (CGT). The company's wholly-owned step-down subsidiary, Strides Pharma Global Pte. Limited, Singapore, received the ANDAs.

The two key abbreviated new drug application (ANDAs) were accepted under the newly introduced CGT as they met the prioritization elements as a potential first generic with a 10-month GDUFA II review date. If the company manages to be the first approved applicant with CGT, these drug products could be eligible for a 180-day CGT exclusivity.

The combined US market for these drug products is US$ 550 million, as per IQVIA MAT.

Strides Pharma is an international company based in Bangalore. The company has seven manufacturing facilities located in three continents including five USFDA approved facilities. On Tuesday, the stock of parent company, Strides Pharma Science Limited closed at Rs. 467.10 per share, up by 3.48 per cent on BSE exchange.