Halo Pharma Becomes Dedicated North American Drug Product CDMO

Halo Pharma has emerged as a standalone drug product contract development and manufacturing organization (CDMO) based out of North America.¹ The news comes as a result of SK Capital Partners entering into a definitive agreement to divest the active pharmaceutical ingredient (API) related assets of the Noramco Group to Siegfried, based in Zofingen, Switzerland. This change allows the organization, which was originally acquired from Cambrex in 2023, to serve as a dedicated platform for drug product services across its sites in Whippany, New Jersey, and Mirabel, Quebec.

How will the transition to a standalone drug product CDMO impact development partnerships?

The restructuring of the organization into a standalone drug product CDMO is intended to provide a more concentrated focus on drug product services in the North American market. This narrowed scope often results in more streamlined technical support throughout the product lifecycle, from initial formulation to commercial manufacturing. The divestiture of the API business enables the remaining leadership to concentrate resources on complex drug product requirements and technical expertise. Discussing this strategic shift, Lee Karras, Normaco Group CEO, noted in a press release,¹ “Anytime you can focus on doing one thing really well, success is inevitable.” He further stated, “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.”

By operating independently, the organization aims to refine its scientific expertise in tech transfer and scale-up/validation. Current operations provide both non-GMP and cGMP services,¹ which are critical for maintaining compliance across different stages of clinical and commercial production. The organization continues to manage a variety of dosage forms, including oral solids, semi-solids, and oral liquids. Its facilities maintain registrations to handle products within the CI–CV Drug Enforcement Administration designations, a necessary capability for partners working with controlled substances.

What infrastructure investments are being made to address complex manufacturing needs?

As part of its growth strategy as a standalone CDMO, the organization is expanding its portfolio to include more complex manufacturing services, specifically focusing on sterile fill/finish capabilities.¹ This expansion is supported by recent investments in sterile product development, including dedicated analytical testing and formulation services. For manufacturing professionals, the introduction of a state-of-the-art Groninger UFVN FlexFill filling line and a Skan isolator, expected to be operational in the second half of 2026, represents a significant increase in available sterile capacity.

The technical specifications of this new equipment are designed for versatility in pharmaceutical manufacturing. The line is configured to fill a range of formats, including vials (2-30 mL), syringes (0.5-10 mL), and various sizes of cartridges using ready-to-use formats.¹ This move into sterile manufacturing, alongside existing capabilities in liquids and solids, allows the CDMO to support clients from the development phase through to commercialization. This shift reflects a broader industry trend where a CDMO must provide highly specialized and integrated capabilities to remain a viable partner for modern drug pipelines.

What other developments are being pushed at Halo Pharma?

Halo Pharma’s Whippany, New Jersey facility is expanding its solid-dose capabilities with the integration of a Gerteis Macro-Pactor, which is scheduled to be online in the first quarter of 2026, according to a Halo Pharma press release.² This investment addresses the specific challenges associated with moisture-sensitive ingredients and high-drug-load formulations through enhanced dry-granulation performance. Discussing the technical advantages, Satish Shetty, senior director, product development & technical services, stated in a press release,² “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 further noted 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.”

Beyond scale-up efficiency, the equipment supports safety and quality standards through a closed, dust-contained design, which is essential for handling potent compounds and controlled substances. This precise control of process parameters facilitates smoother technology transfers and aligns with Quality by Design principles. 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.”

References:

1. Halo Pharma. Halo Pharma to become a stand-alone Drug Product Contract Development and Manufacturing Organization (CDMO). Press Release. Jan 27, 2026.
2. Halo Pharma. Halo Pharma Enhances Manufacturing Capabilities with Macro-Pactor Investment. Press release. Dec 16, 2025.