Strides receives USFDA approval for Cyclosporine Softgel Capsules USP

Strides Pharma Science (Strides) today announced that its stepdown 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.

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