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Piramal, NewAmsterdam Pharma Open Dedicated OSD Form Suite

The investment provides NewAmsterdam Pharma with commercial capacity for a fixed-dose combination of obicetrapib and ezetimibe to meet potential commercial demand.

L-R: Stu Needleman, CCO and Chief Patient Centricity Officer, Piramal Pharma Solutions; Douglas Kling, COO, NewAmsterdam Pharma; Sheng Cui, CMO, NewAmsterdam Pharma; Mahesh Kulkarni, Ph.D., Senior Director, Drug Product, NewAmsterdam Pharma; Manoj Zalpuri, North American Operations Head, Piramal Pharma Solutions; Ian Smart, Managing Partner, Verta Life Sciences; and Daniel Kloss, Sellersville Site Head, Piramal Pharma Solutions.

Piramal Pharma Solutions, a global Contract Development and Manufacturing Organization (CDMO), and NewAmsterdam Pharma Company N.V. have opened a dedicated oral solid dosage (OSD) form suite at Piramal’s facility in Sellersville, Pennsylvania, USA.

This addition aims to 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.

The suite will facilitate the production of NewAmsterdam Pharma’s investigational FDC, a non-statin cholesterol medication to reduce LDL-C. Also, over the next five years, the suite is expected to create more than 20 new jobs at the Sellersville site.

“We are thrilled to expand our OSD production capabilities at the Sellersville facility with this new manufacturing suite,” said Peter DeYoung, CEO, Piramal Global Pharma. “This addition will not only enhance our production capacity and speed, but reinforce our commitment to patient centricity, too.”

“By investing in Piramal Pharma Solutions’ Sellersville facility, we are enabling the manufacture of FDC with exceptional precision and efficiency to meet the future commercial demand,” said Douglas Kling, COO, NewAmsterdam Pharma. “We are excited to continue growing alongside our trusted partner, Piramal Pharma Solutions, and thrilled about the potential for our collaboration to benefit countless patients around the globe.”

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