FOR EUROPEAN & APAC PHARMA COMPANIES
As tariff pressures push European and APAC pharma companies toward US-based manufacturing, ARx offers a proven path forward. We specialize in oral thin films and transdermal patches, with the technical depth to carry complex programs from feasibility through commercial-scale production.
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A member of our transfer team will follow up within one business day.
years in drug delivery
THE TRANSFER PROCESS
STEP 1
We start by understanding where your program stands: formulation state, development phase, existing documentation, and the reason for the transfer.
STEP 2
Our R&D team reviews your dosage form and API profile to flag technical challenges early and determine whether ARx has the right capability to execute the program.
STEP 3
A site change is a regulatory event. We walk through what it means for your filing, including documentation gaps, validation obligations, and any supplements required before you can manufacture in the U.S.
STEP 4
By the end of the initial engagement, you have a clear scope: timeline, resource requirements, scale-up checkpoints, and what it takes to reach clinical supply or commercial production with ARx.
THE TRANSFER PROCESS
Built on 60+ years of dosage form experience, including the first FDA-approved OTC oral thin film and buccal thin film products.
Our R&D works through stability, API compatibility, and scale-up problems that have held up development or reformulation programs.
Phase 1, 2, and 3 clinical supply under cGMP, with full NDA filing support from the same facility.
From process validation through full commercial manufacturing, the documentation, validation packages, and manufacturing records are built to support a well-prepared launch.
Formulation scientists, regulatory specialists, and manufacturing staff working from the same facility on the same timeline, through every phase of the transfer.
U.S.-based, FDA-registered facilities operating under 21 CFR Parts 210 and 211 with ISO-7 cleanrooms and DEA registration for Schedule II through IV controlled substances.
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.
