Piramal Pharma Solutions (PPS), the contract development and manufacturing arm of Piramal Pharma Limited, has announced a partnership with NewAmsterdam Pharma Company N.V. to establish a dedicated oral solid dosage (OSD) suite at its Sellersville, Pennsylvania site in the United States. The new facility will enhance PPS’ oral solid dosage manufacturing capabilities and support NewAmsterdam Pharma’s potential commercial rollout of its fixed-dose combination (FDC) therapy of obicetrapib and ezetimibe, a non-statin cholesterol-lowering medication.
The initiative represents a multi-million-dollar investment in equipment upgrades, space reconfiguration, and advanced manufacturing technologies to improve operational efficiency. The suite will be exclusively dedicated to fixed-dose combination products, equipped with turnkey capabilities for granulation, compression, tableting, and coating.
The investment is aimed at scaling production to meet potentially high commercial demand for NewAmsterdam’s investigational therapy, pending regulatory approval. In addition to Sellersville, PPS leveraged its Ahmedabad PPDS facility in India for product development and its Pithampur site for dual sourcing support, highlighting the company’s integrated global approach.
Peter DeYoung, CEO of Piramal Global Pharma, said, “This addition will not only enhance our production capacity and speed, but also reinforce our commitment to patient centricity.” Douglas Kling, COO of NewAmsterdam Pharma, added, “By investing in PPS’ Sellersville facility, we are enabling the manufacture of the FDC with exceptional precision and efficiency to meet future commercial demand.”
Beyond patient benefits, the Sellersville expansion is also expected to generate over 20 new jobs in the next five years, contributing to the local economy.
The collaboration underscores Piramal Pharma Solutions’ commitment to continuous innovation and global partnerships, while enabling NewAmsterdam to advance obicetrapib—a once-daily CETP inhibitor currently in Phase 3 trials. If approved, the FDC product could provide a new option for patients at risk of cardiovascular disease with elevated LDL-C levels, where existing therapies are insufficient or poorly tolerated.