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22-Aug2018

Strides Shasun's arm receives acceptance from USFDA for two key ANDAs

Strides Shasun's step-down wholly owned subsidiary, Strides Pharma Global, Singapore has received Abbreviated New Drug Application (ANDA) “acceptable for filing” correspondence from the United States Food and Drug Administration (USFDA) for two key ANDAs that met the prioritization factors as a potential First Generic with a 10- month GDUFA II review goal date. As per IQVIA MAT data, the US market for these products cumulatively is $550 million.

The USFDA also granted Strides' request to designate the drug product under these ANDAs as a Competitive Generic Therapy (CGT). If the company is the first approved applicant with such competitive generic therapies, these products could be eligible for a potential 180-day CGT exclusivity, which functions in a similar manner to the Patent Challenge exclusivity for ANDAs.

Strides Shasun is a vertically integrated global pharmaceutical Company headquartered in Bangalore. The company manufactures range of soft gel in category of nutraceuticals, Rx, specialty OTCs and immunosuppressants. 



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