INTERCHEM Corporation
Driving Speed and Precision in Pharma Manufacturing

For more than four decades, INTERCHEM Corporation has helped companies solve the intricate puzzle of pharmaceutical manufacturing by aligning materials, producers and regulatory expertise. The global contract manufacturing partner serves as a one-stop resource in the custom pharmaceutical space, helping clients bring products to market with speed and precision.

Backed by a worldwide network of trusted partners and a track record of navigating complex regulations, Interchem gives clients the confidence and agility to compete in dynamic markets.

Its broad portfolio of chemistries and deep in-house technical and regulatory expertise efficiently delivers tailored solutions. Whether it's product selection, new-product development or custom logistics, Interchem’s experienced team fulfills every need. The team includes industry veterans who have tackled virtually every type of development challenge. Many have been with the company for over 15 years.

“Our advantage is that we can leverage our broad areas of expertise to assist our clients in getting products to market faster,” says Bob Golle, vice president. “We are nimble and operate quickly because we perform all services in-house.”

This integrated model is strengthened by its role as a sales and marketing representative and regulatory agent for a vast network of CMOs across different regions. Clients get access to a wide-reaching, well-coordinated manufacturing ecosystem. Interchem’s wealth of capabilities, applied globally, accommodates an array of project requirements, including production scale, technologies, quality and regulatory requirements and timelines. The focus is always on matching the client’s requirements with the manufacturer most capable of delivering them. This guarantees faster turnaround and fewer headaches.

Interchem also specializes in antibiotic production, custom manufacturing services and patent assessments. Its long-term partnership with ACS Dobfar has enabled it to develop an expansive collection of cephalosporins, penicillins, carbapenems and other anti-infectives, in lyophilized, injectable and bag form, to U.S. and international pharmaceutical companies. It also owns and markets a veterinary brand, U.S. Vet.

For patent assessments, it combines the expertise of its in-house team and outside counsel with whom Interchem has worked for decades. To facilitate the process, its newly formed product selection team leverages extensive market knowledge and accesses numerous highly respected market research databases and services.

Powering Pharmaceutical Success through Compliance, Reliability and Reach

Quality, compliance and supply reliability are its foundational pillars. Interchem assists manufacturers and pharmaceutical clients in writing formal responses to the FDA concerning corrective action plans. Full-time, on-staff GMP auditors regularly inspect manufacturing facilities to determine if they are current with FDA regulations and ensure that suppliers remain compliant with future regulations. By mitigating the inherent risks in the supply chain, it helps clients bring their products to market quickly and ahead of the competition.

Interchem’s logistics department is a significant asset. Its staff applies extensive experience and understanding of the import regulations for drug substances and intermediates to oversee FDA clearance into the U.S.—a process that requires extensive documentation and record keeping. Its global expertise in duty assessment and tax implications, like VAT treatments within Europe, reduces or eliminates costs associated with compliance arrangements. Interchem is also a DEA-licensed importer of controlled and regulated substances in the U.S., with a regularly inspected, DEA-registered warehouse.

“Large pharma companies benefit from our efficiency, while small to medium-sized companies can leverage our extensive reach, experience and resources to minimize sourcing risks, as well as our logistics services to maintain assurance of supply,” says Golle.

Interchem also assesses client supply chain integrity to assure long-term stability, with a focus on foreseeing challenges. When a difficult event arises, like audit observations or deviations, its experience and expertise have proven key to resolving them swiftly and avoiding supply disruption.

Driving Speed, Quality and Cost Leadership

Interchem’s expertise is best seen in action. In one instance, a small pharma client needed help with a small-molecule anti-cancer drug candidate in the pre-clinical stage. The highly complex process included hazardous chemistry and required significant process development and scaling. With the team’s support, the client achieved a high-quality product with extremely aggressive timelines in drug substance (DS) and drug product (DP).

Fourteen linear chemical steps and four side steps, including a chiral separation, were performed. To accelerate development, multiple steps were optimized in parallel. Despite an initially low overall yield, Interchem successfully improved efficiency to deliver a high-quality product. The required amount of DS was ready approximately one year after the project started, and DP development and manufacturing were completed within six months.

A large pharma client with a large volume, late-life cycle, small-molecule drug also benefited from Interchem’s expertise. The client was able to continue in-house manufacturing at its facility for an off-patent DP by lowering the cost of critical starting material.

The team initially provided a basic starting material, with all further steps performed within the client’s plant. An advanced intermediate was then offered at a significantly lower cost. Continuous process improvements have dropped the price by nearly 20 percent over four years, and another proposed process change will allow a further price reduction of up to eight percent. The client was able to maintain a significant market share despite the drug being off patent for several years.

Future-Ready Solutions, Backed by Proven Expertise

As the pharmaceutical landscape continues to evolve, Interchem is determined to continue delivering exceptional services. It is exploring possibilities to incorporate AI into its operations. It has expanded its CMO operations into large molecules like plasmids, nucleotides, mAb and conjugates. Sustainability also remains a continuous process, with conscious steps taken to reduce its carbon footprint through energy-efficient operations and green initiatives.

With deep expertise and a focus on quality, Interchem sets the standard in pharmaceutical manufacturing, delivering the speed and reliability global companies rely on. Its integrated approach and regulatory strength help clients navigate complexity and confidently reach the market.