Q&A: Why Is Halo Pharma Expanding Into Sterile Injectables Now?

Halo Pharma is preparing to bring a new sterile fill-finish manufacturing platform online, marking the company's first move into syringe, vial, and cartridge filling. The build-out is designed to support sterile injectable manufacturing from clinical development through commercial production, and it combines Groninger filling technology with SKAN isolator systems and ready-to-use formats from Schott, Stevenato, and Gerresheimer, covering prefilled syringes (0.5–10 mL), vials (2–30 mL), and cartridges (1–5 mL).

Before GMP qualification activities begin, PharmTech spoke with Lee Karras, group CEO of Halo and CEO of Woodstock Sterile Solutions, about the reasoning behind the investment and where it fits into the company's broader manufacturing strategy.

Watch the full video interview with Karras: Three Formats, One Platform: Halo's New Sterile Fill-Finish Line

PharmTech: How Are Tariffs Factoring into the Timing of This Investment?

Karras: Tariffs really hit our customers more than they hit us directly. What makes the timing attractive to us is the onshoring trend around injectable products specifically. That's critical not just for securing the US pharmaceutical supply chain, but also for meeting the quality standards the FDA expects. We're pursuing this for two reasons: we want to deliver a high-quality product, and we believe the industry needs more domestic manufacturing capacity, especially for injectables.

Why Move into Fill-Finish Now?

This is genuinely new territory for us. But we see the domestic injectable supply chain as being at capacity right now, which makes this the right moment to bring the investment online. There's also the nature of the asset itself. It's a modern, state-of-the-art platform, unlike a lot of what's been installed historically in this space, and we think that checks a lot of the boxes larger pharma customers look for in a CMO today.

Can You Explain the Apotex Partnership?

We structured that deal because we wanted an anchor customer, and Apotex already had products in hand. They were looking for a US source. It was important for us to find a partner who could get us out of the gate and trigger an FDA inspection through their products. From there, the broader strategy was to add another dosage form to our portfolio. We're the only domestic source that produces oral solids, liquids, injectables, and blow-fill-seal products within one network of plants. No one else in the US can do that. On top of that, our ability to handle narcotic manufacturing at Halo is an attribute customers actively seek out.

How Does this Fit into the Larger Onshoring Conversation in Pharma?

Ever since onshoring became a bigger topic in the industry, driven by various incentives and disincentives around domestic manufacturing, we've heard the same thing from customers: they want another domestic source. Historically, that request was tied to oral solids or liquids being made in Europe. Now customers are telling us they want to bring their injectables onshore as well. For us, it's a continuation of a strategy we already had around domesticating US pharmaceutical production. The Noramco divestiture only involved the active pharmaceutical ingredient piece of our business, not the downstream fill-finish, oral solids, or liquids operations. We stepped away from the API business to focus on drug product, which we see as the area with the biggest growth potential as supply chains continue to domesticate.

What Does the Product Mix Look Like Going Forward?

The plan is to focus on high-value-add generics and narcotics. That's one pillar. The rest of the business will center on branded products, and one area we'd like to grow into is personalized medicine and gene therapy. Batch sizes there aren't necessarily large, but the quality and flexibility we bring on the injectable side positions us well as a partner for companies exploring gene therapy. Between the high-value generics and specialized branded products, that mix is what we expect to shape this business going forward.