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Strides Pharma Science’s arm gets USFDA’s nod for Solifenacin Succinate Tablets

27 Sep 2019 Evaluate

Strides Pharma Science’s step down subsidiary -- Strides Pharma Global Pte (SPG) Singapore, has received approval for Solifenacin Succinate Tablets, 5 mg and 10 mg from the United States Food & Drug Administration (USFDA). The product is a generic version of Vesicare Tablets, 5 mg and 10 mg, of Astellas Pharma US, Inc.

According to IQVIA MAT data, the US market for Solifenacin Succinate Tablets, 5 mg and 10 mg is approximately $820 million. The product will be manufactured at Alathur facility in Chennai and will be marketed by Strides Pharma Inc. in the US market. The company has 102 cumulative ANDA filings with USFDA of which 66 ANDAs have been approved and 36 are pending approval.

Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.

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