Noramco Announces Strategic Alignment With Purisys & Halo Pharma, Launching the Noramco Group as an Integrated North American-Based API & Drug Product Supply Chain Services Provider

Noramco recently announced its launch of the Noramco Group, a newly created comprehensive North American-based supply chain solution including subsidiaries Purisys, Noramco, and the newly acquired drug product CDMO, Halo Pharma. This strategic combination unites the strengths of these entities to provide a robust, North American-based supply chain solution for both clinical and commercial APIs and drug products.

In the wake of escalating drug shortages in the US and quality concerns that are disrupting patient access, Noramco is taking a pivotal step to address these critical issues. The current crisis, primarily driven by lack of reliable foreign supply, limited domestic manufacturing capacity for APIs and drug products, and logistical bottlenecks, has led to unprecedented challenges in ensuring the availability of essential medications. The COVID-19 pandemic underscored the fragility of the existing system, heavily reliant on overseas manufacturing (often from a single foreign source of supply) and exposed the risks of a globalized supply network. In response, Noramco is championing a shift toward enhanced supply chain performance and increased domestic production in North America with the formation of the Noramco Group.

Lee Karras, CEO of the Noramco Group, emphasized the importance of this alignment in the current market, stating “The COVID-19 pandemic exposed critical vulnerabilities in our drug supply chain. Government responses, while well-intentioned, proved to be somewhat superficial, leaving the threat of future disruptions unaddressed. The formation of the Noramco Group is our proactive solution to some of these challenges. We are uniquely positioned to provide our customers with a complete, North American-based supply chain solution. By leveraging our advanced manufacturing capabilities, stringent quality control and compliance measures, and timely delivery, we aim to mitigate the risks associated with drug shortages and ensure a stable and reliable supply of vital APIs and drug products. We are committed to supporting patients by ensuring the supply of critical, lifesaving drugs.”

Noramco, based in Wilmington, DE, supplies commercial APIs globally, supporting various medical treatments such as, pain management and drug abuse treatment. Purisys, located in Athens, GA, offers specialized clinical API development and manufacturing services, focusing on controlled substances and pharmaceutical reference standards. Halo Pharma, with operations in Whippany, NJ, and Montreal, Quebec, is a contract development and manufacturing organization (CDMO) that provides a wide range of manufacturing services for diverse dosage forms, catering to both brand and generic pharmaceutical clients from development through commercialization.

The alignment of these three companies is set to reduce overall complexity in industry processes, minimize logistics costs, and improve regulatory compliance. A notable benefit, especially for pharma and biotech companies working with New Chemical Entities (NCEs), includes the protection of intellectual property with a known domestic source. Additionally, the new Noramco Group structure of combined API and drug product CDMO services in North America could potentially increase opportunities for securing National Institutes of Health (NIH) and other government grants and contracts. This strategic move positions the Noramco Group at the forefront of US pharmaceutical supply chain reliability.

To explore how the Noramco Group can support API to drug product supply needs, visit www.noramco.com. To learn about customizing a solutions-oriented approach to clinical trial material delivery and commercial scale delivery of APIs and finished dose forms, please see Noramco Group executives at DCAT Week, March 18-21, 2024, in New York City or contact the Noramco Group online.

Noramco is a global supplier of active ingredients (APIs) – including controlled substances – to the pharmaceutical industry. Noramco’s APIs are used by many of the leading brand and generic pharma companies, as well as small- to mid-scale pharma companies. Noramco’s APIs are used in over 350 products and sold in over 30 counties. Noramco manufactures APIs that are used across a broad set of indications such as ADHD, pain management and abuse treatment and prevention.

Purisys is a leading supplier of API CDMO services and pharmaceutical reference standards. Its 17,000-square-foot manufacturing facility and innovation center is staffed by scientists, engineers, and other professionals who have decades of experience in complex high-barrier custom synthetic chemistry. Purisys’ CDMO services are designed to support the development of custom APIs for a wide range of clinical and niche commercial applications. Purisys has specialized capabilities in controlled substance APIs, possessing 6 DEA registrations encompassing 48 drug codes. Purisys stocks a catalog of more than 250 commercial reference standards that support pharmaceutical drug product development and manufacturing.

Halo Pharma is a rapidly growing contract development and manufacturing organization (CDMO) that provides scientific and development expertise, as well as a wide spectrum of manufacturing services. Halo offers fully integrated capabilities in a variety of dosage forms including tablets, capsules, powders, liquids, creams, sterile and non-sterile ointments and suppositories. The company is registered to work with any of these dosages in the CI-CV DEA designations. Halo Pharma’s capabilities in the areas of tech transfer, process and product development, production, scale-up/validation and analytical method development allow us to partner with clients from development through commercialization or at any point along the way. For more information, visit services@halopharma.com.