A vertically integrated platform pairing sterile manufacturing with nationwide distribution. Facility built. Distribution live. Manufacturing advancing to launch — one partner, from molecule to bedside.
The supply chain is fragmented. We own the links that matter most — sterile manufacturing and nationwide distribution — and run them to a single standard.
A CMO/CDMO delivering development, manufacturing, and lab testing — from small-molecule drug product to 503B, with biosimilars on the roadmap.
ManufacturingA nationally licensed wholesaler delivering thousands of SKUs to pharmacies and health systems — fast, compliant, and unmatched on value.
DistributionThe forces reshaping medicine are exactly the ones a domestic, integrated platform is built to answer.
A single medicine usually passes through five separate companies — a developer, a manufacturer, a testing lab, a 503B compounder, a distributor. Every hand-off adds cost, delay, and shortage risk. Synergeia is all five, under one roof, to one standard.
No competitor archetype spans the whole chain — global CDMOs only make, 503B outsourcers only fill, wholesalers only move. Synergeia is the single integrated platform that does all of it, domestically. Illustrative.
A full-service CMO/CDMO: product research, development, manufacturing, contract lab testing, and regulatory support — with sterile 503B services and CDMO development today — and a roadmap toward full-scale commercial biosimilars.
Broad inventory across every dosage form and therapeutic category, a 99% fill rate, and fast, DSCSA-compliant fulfillment — with pricing and service that pharmacies actually feel.
Brands seeking a manufacturing partner, and pharmacies seeking a distributor — we'd like to hear from you.
Get in touchSynergeia’s manufacturing division (Sankav) is a contract manufacturing and development organization (CMO/CDMO) for small-molecule and organic medicines — with contract lab testing and sterile 503B services today, and a bold path to commercial biosimilars.
From early formulation through commercial supply and release testing, we run the whole program so brands and providers don't have to stitch it together. State-of-the-art facilities with automated, advanced technologies — and a clear roadmap to scale.
A complete contract manufacturing platform — with room to grow into biologics.
Commercial-scale production of small-molecule and organic drug product.
Formulation, process development, and scale-up from concept to commercial.
Analytical testing and QC release — sterility, potency, and stability.
Sterile, office-use compounded and injectable preparations to cGMP — coming soon.
Innovative, personalized therapies for common and rare diseases.
Nutraceuticals and advanced drug-delivery platforms.
Research, documentation, and regulatory support through submission.
Building toward biosimilar development and manufacturing.
No outsourced labs, no contract fillers. Material moves one direction across a single validated site — 30,000 sq ft at 20 Newburgh Road, Washington Twp, NJ.
Waters Acquity · Empower 3 (Part 11) · LAL endotoxin — release testing in-house.
Sterility, bioburden, and continuous environmental monitoring.
Multi-effect still ≥80°C loop · pure steam · autoclave 121°C.
ISO 5→7→8 cascade · H14 HEPA · ICH stability chambers.
Advanced, automated technologies at 20 Newburgh Road, Washington Township, New Jersey.
Material moves one direction across a single validated site. Explore each stage.
Small-molecule and organic drug product across the formats providers use most.
“Through innovative, state-of-the-art personalized medicines, we seek to cure and prevent common and rare diseases for diverse individuals in rural and urban communities.”
Tell us where you are — development, manufacturing, testing, or all three — and we'll map the path.
Talk to manufacturingA nationally licensed wholesale distributor of FDA-approved generics, branded, and OTC medicines — thousands of SKUs delivered to pharmacies and health systems with a 99% fill rate.
A nationally licensed footprint means one wholesale partner for the whole country. Hover a state to see its status.
Generics, branded, and OTC — over 3,000 SKUs across every therapeutic category, sourced exclusively from FDA-approved manufacturers and moved with the speed providers need.
Reliable fulfillment for high-volume, high-stakes environments and IDNs.
Everyday needs at competitive pricing, without complex contracts.
Handling for specialty and mail-order pharmacy programs.
Consistent supply for LTC providers and wholesale distributors.
Open an account for broad inventory, a 99% fill rate, and service that treats every order as urgent.
Open an accountA vertically integrated 503B · CMO · CDMO · biosimilar platform — facility built, distribution live, manufacturing advancing toward launch. We're evolving toward full-scale commercial biosimilars, powered by automation, robotics, and an intelligent supply chain.
The critical medicines America can’t afford to import — made here. The forces reshaping medicine are exactly the ones a domestic, integrated platform is built to answer.
A $42B market shadowed by 253 shortages — where domestic, flexible capacity is scarce.
A $191B segment growing ~9% a year, with persistent chemotherapy shortages.
Scaling from ~$4B toward $17.4B at ~15% CAGR — capacity-constrained industry-wide.
A $236B patent cliff by 2034 — U.S. fill-finish capacity is the bottleneck, not the biology.
Market sizing is directional. Sources: IMARC, Grand View, DrugPatentWatch, FDA drug-shortage list (2025–26). Policy and reshoring momentum increasingly favor domestic sterile manufacturing.
Global CDMOs have scale but not agility; regional 503B outsourcers have niche fill but not end-to-end. Only Synergeia combines all four — integrated, multi-modal, and domestic.
End-to-end manufacturing plus 47-state distribution — one Site Master File, no handoff seams.
Part-11 analytics (Waters/Empower), robotic RABS/isolator fill, DSCSA serialization, DEA vault.
Reconfigure suites across 503B, CMO/CDMO, peptide, and biosimilar — pivot to where demand is.
Built. Replicating it means 12–24 months, major capex, and 47-state licensure — we’re already there.
Deliberate, capability-by-capability — from sterile compounding today to commercial biologics.
Sterile compounding, contract manufacturing & development, and lab testing — 30,000 sq ft at 20 Newburgh Rd.
Expanded sterile capacity, CDMO scale-up, and robotics-driven fill-finish as the footprint grows.
Full-scale, highly commercial biosimilar manufacturing at a 200,000 sq ft facility.
A step-change in capacity — roughly a 6.6× expansion — to house commercial biologics, automated production lines, and integrated distribution under one roof.
Every major risk already has a concrete, in-place answer — a de-risked platform, not a bet on a plan.
Facility constructed and validated through Stage 8 of 12 — a real asset in the ground, not a rendering.
Spectrum operates across 47 states today — cash-generating, funding the build as it goes.
Validated cleanrooms, mock inspections, and regulatory consultants ahead of FDA registration.
Modular suites across 503B, CMO/CDMO, peptide, and biosimilar spread the demand risk.
12–24 months, major capex, and 47-state licensure to replicate — we’re already there.
Reshoring and domestic-supply momentum push demand toward U.S.-made sterile capacity.
The next-generation plant is engineered to run smarter — faster batches, tighter quality, fewer touchpoints.
Automated, isolator-based filling for injectables — repeatable sterility at commercial speed.
Continuous, automated lines that scale output without scaling variability.
Real-time analytics and vision inspection accelerate testing and release with fewer errors.
A live digital model of the plant with continuous environmental and process monitoring.
Automated storage and retrieval with cold-chain integrity built in.
One connected data thread from development to delivery — full traceability, real visibility.
No outsourced labs, no contract fillers. Development, manufacturing, testing, and distribution on a single validated site and one Site Master File — no handoff seams, from molecule to bedside.
Partners, providers, and future collaborators — join us as we scale from sterile compounding to commercial biosimilars.
Start the conversationThis page describes forward-looking plans and aspirations. Facility size, timelines, and capabilities reflect current intent and may change. Nothing here is an offer, solicitation, or guarantee.
In contract manufacturing and regulated distribution alike, trust is earned batch by batch and shipment by shipment.
Built to current Good Manufacturing Practice — cGMP certification & FDA registration coming soon.
Contract lab testing gates every lot — sterility, potency, stability.
NABP-accredited, track-and-trace compliant across distribution.
Product sourced exclusively from FDA-approved manufacturers.
We're glad to walk partners and providers through our quality systems.
Request a walkthroughWhether you need a manufacturing partner, a distributor, or both — tell us what you're solving for.