Halo Pharma becomes dedicated North American drug product CDMO after emerging as a standalone contract development and manufacturing organization focused exclusively on drug product services in North America. The transition follows SK Capital Partners’ decision to divest the active pharmaceutical ingredient assets of the Noramco Group to Siegfried, enabling Halo Pharma to operate independently across its facilities in Whippany, New Jersey, and Mirabel, Quebec.
Acquired from Cambrex in 2023, the company previously functioned as a drug product development and manufacturing organization. Halo Pharma streamlined the company into a stand-alone platform to focus on formulation, scale-up and commercial manufacturing capabilities.
The move is intended to strengthen development partnerships by providing more focused technical support across the drug product lifecycle. With the API business divested, leadership can align scientific expertise and infrastructure around complex dosage forms and regulatory requirements. Discussing the shift, Lee Karras, Noramco Group CEO, stated in a press release, “Anytime you can focus on doing one thing really well, success is inevitable.” He added, “I look forward to working with the Halo teams more directly at both sites. We already have significant interest from established pharma companies looking to sign up in advance for sterile CDMO services.”
As Halo Pharma becomes a dedicated North American drug product CDMO, the company continues to provide both non-GMP and cGMP services critical to clinical and commercial programs. Current operations support oral solids, semi-solids, and oral liquids, while maintaining Drug Enforcement Administration registrations covering CI–CV designations, an important capability for partners working with controlled substances.
The increased demand for Halo Pharma’s technical service offerings related to complex manufacturing prompted expansion plans into sterile fill and finish services. Halo has invested in both analytical testing as well as formulation capacity with the intent of supporting sterile products. The addition of a Groninger UFVN FlexFill filling line and Skan isolator are expected to be ready for operation in H2 2026 and will provide ample sterile capacity.
Formats supported on the filling line include multiple vials sizes ranging from 2 mL to 30 mL; multiple syringe sizes ranging from 0.5 mL to 10 mL; as well as ready-to-use cartridges. Adding this capacity enables the CDMO to service products from clinical development through commercialization, which is in line with industry expectations of expanded drug product services.
Further investments are also underway at the Whippany, New Jersey site, where Halo Pharma is expanding its solid-dose manufacturing capabilities. The facility is set to integrate a Gerteis Macro-Pactor in the first quarter of 2026. Commenting on its advantages, Satish Shetty, senior director, product development and technical services, said, “One of the major advantages of adding the Macro-Pactor is that the process parameters established during early-phase development translates almost directly into larger batch sizes.” He added that the equipment “eliminates the typical disconnect between small-scale R&D and large-scale manufacturing, reducing scale-up risk, timelines, and the need for reformulation.”
The Macro-Pactor also supports closed, dust-contained processing, which is essential for handling potent compounds safely. According to Lee Karras, group chief executive, “Investing in the Macro-Pactor reinforces Halo Pharma’s commitment to delivering high-quality, scalable manufacturing solutions for our clients. It ensures that they can confidently advance their programs with predictable outcomes and faster timelines.”
