USFDA12 Nov 2024, 06:45 pm
Shilpa Medicare's CDMO Partner Unicycive's NDA for Oxylanthanum Carbonate Accepted by USFDA
AI Summary
Shilpa Medicare announces the acceptance by the USFDA of the NDA filed by its CDMO partner Unicycive for Oxylanthanum Carbonate (OLC). If approved, OLC has the potential to significantly improve the treatment burden for hyperphosphatemia patients with chronic kidney disease (CKD) on dialysis. The product is expected to be commercialized and launched in the US market in the second half of 2025. Shilpa Medicare, an integrated pharmaceutical group, provides end-to-end CDMO services to global pharmaceutical companies and has a strong R&D and manufacturing capabilities.
Key Highlights
- USFDA accepts NDA for Oxylanthanum Carbonate (OLC) filed by Shilpa Medicare's CDMO partner Unicycive
- OLC has potential to improve treatment burden for hyperphosphatemia patients with CKD on dialysis
- OLC likely to result in better patient adherence due to lower pill burden and swallowing convenience
- Unicycive and Shilpa Medicare have a long term manufacturing contract for OLC
- OLC expected to be commercialized and launched in the US market in the second half of 2025