Strides Pharma's arm gets USFDA’s approval for Cyclosporine Softgel Capsules
3rd Aug 2022

Strides Pharma Science’s (Strides) step-down wholly owned subsidiary -- Strides Pharma Global, Singapore, has received approval for Cyclosporine Softgel Capsules USP (Modified), 25 mg, 50 mg, and 100 mg from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Neoral Capsules 25 mg, 50 mg, and 100 mg, of Novartis Pharmaceuticals Corporation (Novartis). Cyclosporine Softgel Capsules is part of Strides niche product portfolio with limited competition in the US market.

Strides is the first Indian company to get approval for the product. The approval further strengthens Strides immunosuppressant portfolio for the US markets which now comprises of Mycophenolate Mofetil tablets and capsules, Tacrolimus capsules and Cyclosporine Softgel Capsules.

According to IQVIA MAT data, the US market for Cyclosporine Capsules USP, 25 mg, 50 mg, and 100 mg is approximately $ 91Mn. The product will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.

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.