Shilpa Medicare Limited — Important, 12-11-2024: General Updates

Shilpa Medicare has received confirmation from its CDMO partner, Unicycive Therapeutics, that the US FDA has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC), aimed at treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. If approved, the drug could significantly enhance patient adherence by reducing the pill burden, allowing patients to swallow fewer, smaller pills. Unicycive has secured a long-term manufacturing contract with Shilpa for OLC production, which is projected to launch commercially in the US market during the second half of 2025, following the scheduled PDUFA target action date of June 28, 2025. This strategic move may bolster Shilpa’s position in the growing pharmaceutical space, presenting a positive outlook for future growth opportunities.