Mumbai-based Piramal Pharma Solutions, a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd., and NewAmsterdam Pharma Company N.V. have announced the opening of a dedicated oral solid dosage (OSD) form suite at Piramal's facility in Sellersville, Pennsylvania, USA.
As one of Piramal Pharma Solutions' focused drug product facilities, the Sellersville site provides comprehensive development and manufacturing services for various formulations, including several forms of OSDs. This addition will increase operational efficiency, helping NewAmsterdam Pharma to deliver its investigational drug therapy, if approved, to patients in need.
The suite represents a multi-million-dollar investment in equipment upgrades and enhancements to improve the site's capabilities. This includes a reconfiguration of existing space to create a dedicated OSD suite that will be used exclusively for fixed dose combination products. The new suite is designed for turnkey, multi-layer tablet production, equipped with advanced capabilities and technology to support granulation, compression, tableting, and coating.
This suite will facilitate the production of NewAmsterdam Pharma's investigational FDC, a non-statin cholesterol medication to reduce LDL-C.
Although the suite is essential to the FDC's production, the partnership between Piramal Pharma Solutions and NewAmsterdam Pharma extends beyond the Sellersville site. Piramal's Ahmedabad PPDS site played a crucial role in the product's development, while its Pithampur site provides dual sourcing support.
