Strides Pharma Science Limited (Strides) announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, 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 US$ 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.

The company has 279 cumulative ANDA filings (including recently acquired portfolio from Endo at Chestnut Ridge) with USFDA of which 259 ANDAs have been approved and 20 are pending approval. The company has set a target to launch ~ 20 new products every year in the US.