BIO 2026 · SAN DIEGO, CA · JUNE 23–26

MEET THE ARx TEAM AT BIO 2026

Is first-pass metabolism limiting what your compound can achieve orally? Is your patient population struggling to take tablets reliably? Or maybe your CDMO lacks the manufacturing depth to carry your program through commercial launch? ARx has been solving these exact problems commercially for over 20 years across oral thin film and transdermal—and we’d love to meet with you at Bio.

Schedule a Meeting at Booth 1325

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years in drug delivery

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Years Commercial Manufacturing

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Positive FDA Inspections

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WHO WE ARE

The pioneers of oral thin film for systemic drug delivery

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.

Full Lifecycle Development

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.

Lifecycle Extension

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.

Tech Transfer Capabilities

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.

Delivery Built for the Patient

Oral thin film and transdermal formats improve therapeutic onset, strengthen patient adherence, and remove the swallowing barrier entirely. For programs indicated for elderly, pediatric, or oncology populations, that distinction is clinical, not cosmetic.

FEATURED TECHNOLOGY

MicroDEP: The First FDA-Approved Non-Matrix Thin Film

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?

High-potency APIs that require dosing precision conventional film loading cannot achieve
Heat-labile or volatile compounds where standard processing temperatures create a stability problem
Neurological and pain indications where rapid onset is a clinical requirement, not a formulation preference
Compounds indicated for pediatric, geriatric, or oncology patients where swallowing a tablet is not a reliable option

If any of those describe a program in your portfolio, find the ARx team at the LSPA Pavilion, Booth 1325.

4x

API concentration at 30 minutes versus conventional films

5 minutes

Plasma levels detectable within five minutes post-dose

10 μg

Dose precision down to 10 micrograms, consistent from Phase I through commercial scale

Buccal · Sublingual

Available across multiple thin film formats, with formulation depth to match the right delivery route to your compound’s biology

CASE STUDY

From Stranded Program to First-In-Class FDA Approval

When a specialty pharma company’s development partner shut down mid-program, their API 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.

PROGRAM AT A GLANCE

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

BOOK TIME WITH ARx AT BIO

If a drug delivery question is open for any of your programs, or a compound in your portfolio could benefit from a partner with commercial OTF and transdermal depth, the team will be at Booth 1325 all week.