CPHI MILAN · FIERA MILANO · OCTOBER 6–8, 2026
Sponsors evaluating a delivery partner usually end up choosing between two options: a large CDMO where the program disappears into a queue, or a small shop with attention to spare but not the regulatory depth to see it through.
ARx is a fourth-generation, family-owned drug delivery partner with full-service CDMO capabilities. The same team that scopes your program at feasibility carries it through commercial launch.
Meet us at CPHI Milan, October 6-8 at Fiera Milano →
Director of Sales, ARx
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years in drug delivery
WHO WE ARE
ARx is a collaborative drug-delivery partner rooted in a fourth-generation family company, with over 20 years of full-lifecycle OTF and transdermal development. We hold NDA and ANDA approvals in both modalities, have taken first-to-market products through commercial launch in each, and produce more than 100 million units annually at our FDA- and DEA-registered facility in Glen Rock, PA.
Feasibility screening and in-silico pre-formulation modeling through clinical supply, NDA and ANDA filing, and commercial-scale manufacturing. The formulation team and the manufacturing team are the same team, working from the same facility on the same timeline.
A new delivery route can differentiate an existing asset commercially, extend its market exclusivity, and produce a better patient experience. ARx carries those programs from formulation through commercial launch with the manufacturing depth to execute them.
When a program needs a new manufacturing home, process knowledge has to move with it. ARx has handled complex transfers across OTF and transdermal formats, including programs that other CDMOs could not deliver on.
Oral thin film and transdermal formats improve therapeutic onset and strengthen patient adherence. For programs indicated for elderly, pediatric, or oncology populations, that distinction is clinical, not cosmetic.
WHAT ARx BRINGS TO YOUR PROGRAM
Precision coating equipment monitors film thickness in real time, while oven drying under controlled conditions protects API integrity as the film cures. The same lines that wind, slit, and package finished film also scale from Phase I batches of a few thousand units to commercial orders exceeding 100 million units annually.
FDA-registered, cGMP-compliant facilities operate under 21 CFR Parts 210 and 211 for drug products and CFR 820.20, .30, .50, and .100 for combination products, with DEA registration covering CII–CIV. That foundation backs multiple approved 505(b)(2) and ANDA programs, alongside a clean inspection record since 2006.
Development starts with feasibility screenings on solubility, permeability, and film-forming compatibility, backed by proprietary in-silico modeling that predicts pharmacokinetic outcomes. That same process also supports lifecycle management, turning injectables into an oral film or multi-day dosage into a single patch.
FOR COMPOUNDS THAT NEED FLEXIBLE ABSORPTION ROUTES
Dissolves on the tongue in 5 to 30 seconds and releases API into saliva for GI absorption, supporting drug loading up to 65mg across salts, free-base compounds, and potent APIs. That flexibility makes it a practical fit for patients with dysphagia, including pediatric and geriatric populations.
Dissolves under the tongue and enters systemic circulation directly through the sublingual mucosa, bypassing hepatic first-pass metabolism entirely. In human studies, quantifiable API appeared in plasma within 5 minutes, with Tmax reached by 30 minutes.
Adheres to the inner cheek and releases API through the buccal mucosa over a controlled window of 30 minutes to 12 hours, also bypassing first-pass metabolism. In testing, buccal films achieved 2x the systemic exposure at just 25% of conventional drug loading, with no toxic metabolites detected.
WHAT ARx BRINGS TO YOUR PROGRAM
Routes API through the skin directly into systemic circulation, bypassing GI transit and first-pass hepatic metabolism. Controlled release extends up to 7 days per application, supported by enhancer combinations engineered to optimize permeation and steady plasma levels.
Delivers API directly to the treatment site, limiting systemic absorption and confining pharmacokinetic exposure to the local tissue itself. Release rate and duration are calibrated to indication, tissue type, and API permeability, tailored to each specific program.
FEATURED TECHNOLOGY
ARx’s proprietary micro-deposition technology deposits micro-sized formulations directly onto the film surface rather than dispersing them through a polymer matrix, delivering clinical performance and commercial IP that conventional formats cannot provide.
Which Programs Commonly Qualify?
If any of those describe a program in your portfolio, find the ARx team at the LSPA Pavilion, Booth 1325.
API concentration at 30 minutes versus conventional films
Plasma levels detectable within five minutes post-dose
Dose precision down to 10 micrograms, consistent from Phase I through commercial scale
Available across multiple thin film formats, with formulation depth to match the right delivery route to your compound’s biology
CASE STUDY
When a specialty pharma company’s development partner shut down mid-program, their buccal buprenorphine candidate had no path to clinical supply. ARx inherited an unsolved suspension challenge across seven product strengths, manufactured Phase 1, 2, and 3 clinical lots on schedule, and carried the program to first-in-class FDA approval.
The result was the first FDA-approved buccal film for this indication. ARx resolved a formulation problem no competing CDMO had cracked, kept the regulatory timeline intact, and delivered a validated commercial process ready for launch.
DELIVERY PLATFORM
Buccal Film
API CHALLENGE
Partial Water Solubility, 7 Strength Variants
TRANSFER TRIGGER
Development Partner Shutdown, No Commercial Capability
REGULATORY FILING
NDA, Phase 1, 2, & 3 Clinical Supply
OUTCOME
First FDA-Approved Buccal Film for This Indication
Looking to move manufacturing to the U.S.? Start by telling us about your program. Our team will follow up with next steps.
