Strides Pharma gets FDA approval for Cyclosporine Softgel Capsules

Strides Pharma Science said that its stepdown fully-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has secured approval from the US Food and Drug Administration (USFDA) for Cyclosporine Softgel Capsules USP (Modified), 25 mg, 50 mg, and 100 mg.

The immunosuppressant medication product is bioequivalent and therapeutically equivalent to Neoral Capsules 25 mg, 50 mg, and 100 mg, owned by Novartis Pharmaceuticals. It is indicated for the prophylaxis of organ rejection in liver, kidney, and heart allogeneic transplants as well as used for the treatment of severe rheumatoid arthritis and psoriasis.

According to Strides Pharma Science, Cyclosporine Softgel Capsules is part of its niche product portfolio with limited competition in the American market. The company’s immunosuppressant portfolio for the American market is now made up of Mycophenolate Mofetil tablets and capsules, Tacrolimus capsules, and Cyclosporine Softgel Capsules.

Strides Pharma gets FDA approval for Cyclosporine Softgel Capsules. Photo courtesy of Joby.joe/Wikipedia.org.

As per IQVIA MAT data, the US market for Cyclosporine Capsules USP, 25 mg, 50 mg, and 100 mg is around $91 million.

Strides Pharma Science said that Cyclosporine Softgel Capsules will be manufactured at its facility at Bengaluru and will be marketed by Strides Pharma Inc. in the American market.