Do you replace our existing serialization vendor?

No. One Trust sits alongside your L1–L4 stack, adding NBR as a tamper-resistant authentication layer and a patient-facing verification channel.

Which regulations do you support?

DSCSA (US), EU FMD/EMVS, Turkey ITS, Saudi RSD, India DGFT iVEDA, Russia Chestny ZNAK and GS1 Digital Link.

How fast can we deploy on a new line?

A single line typically goes from kick-off to live production in 6–10 weeks including OQ/PQ.

Can patients verify without an app?

Yes — every NBR resolves via a standard smartphone camera; no app install required.

Pharmaceutical · Industry Solution

Patient-safe authentication for every pack.

DSCSA-, EU FMD- and DGFT-ready serialization, aggregation and last-mile verification — anchored by One Trust's Non-Reproducible Barcode.

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Industry

Pharmaceutical

Counterfeit medicines are a patient-safety and revenue crisis.

DSCSA (US), EU FMD, DGFT (India) & GS1 compliant
Line-speed printing on cartons, blisters, vials & bottles
Patient-facing verification via any smartphone
Batch recall & lot traceability in minutes, not weeks

Industry overview

Counterfeit medicines are a patient-safety and revenue crisis.

One Trust gives pharma manufacturers a compliant, patient-facing authentication layer that integrates with your existing serialization stack and closes the last-mile verification gap regulators, patients and hospitals now demand.

Counterfeit statistics

The scale of the problem.

Global counterfeit pharma market: $200B+
Global counterfeit pharma market
Source · OECD
Medicines in LMICs are substandard/falsified: 1 in 10
Medicines in LMICs are substandard/falsified
Source · WHO
Annual deaths linked to fake medicines: 300k+
Annual deaths linked to fake medicines
Source · WHO
Of consumers verify pharma before use when enabled: 62%
Of consumers verify pharma before use when enabled

Business risks

What's at stake for pharmaceutical leaders.

Patient harm & liability

Falsified APIs cause adverse events and expose manufacturers to litigation and regulator action.

Regulatory non-compliance

Missing serialization or aggregation invites market-access bans and shipment holds.

Revenue leakage

Diverted stock and grey-market flows erode price integrity across regulated markets.

Brand & trust erosion

A single counterfeit incident on social media damages HCP prescribing behaviour.

How One Trust solves it

One authentication layer across pack, patient and portal.

Serialize every unit at line speed with NBR, aggregate through your packaging hierarchy, and let anyone — patient, pharmacist, inspector — verify authenticity with a scan.

NBR at line speed

Cryptographic codes printed inline with existing CIJ / TIJ / laser marking systems.

Aggregation hierarchy

Unit → bundle → carton → pallet capture with full parent-child integrity.

Patient scan verification

GS1 Digital Link resolvers with multilingual patient information leaflets.

Diversion detection

Geo-fenced scans surface parallel imports and grey-market flows in real time.

Regulator reporting

Turnkey DSCSA T3 data, EMVS uploads and DGFT iVEDA feeds.

Recall command centre

Isolate affected lots and notify partners with one click.

Workflow

Deployment, end to end.

Mint NBR identity

Every SKU/lot receives a Non-Reproducible Barcode with cryptographic anchor at print time.

Print & apply

Codes are printed inline at your existing lines — no new hardware, no line slowdown.

Serialize & aggregate

Unit → carton → pallet parent-child hierarchy captured across your network.

Authenticate in the field

Consumers, retailers, inspectors and partners scan with any smartphone camera.

Act on intelligence

Real-time alerts, geo heatmaps and BI feeds flow to your brand-protection team.

ROI

Outcomes that move the P&L.

12–18%

Recovered revenue from stopped diversion

Typical uplift within 12 months of rollout in emerging markets.

80%

Faster recall execution

From weeks to hours on affected lots.

3–6x

First-party patient data growth

Verified scans build a compliant HCP/patient CRM.

100%

Serialization compliance

DSCSA, EU FMD, DGFT out of the box.

Case study

Enterprise outcomes.

Top-10 Global Pharma · APAC & MEA

Challenge

Rising counterfeit incidents on a flagship cardiovascular brand in five emerging markets, with parallel-import diversion eroding regulated-market pricing.

Outcome

Deployed NBR across 220M cartons/yr in 18 months. Counterfeit complaints down 74%; three organized counterfeit rings dismantled in partnership with regulators.

Cartons/yr protected: 220M
Cartons/yr protected
Counterfeit complaints: -74%
Counterfeit complaints
Global rollout: 18 mo
Global rollout

See more case studies

FAQ

Common questions.

Demo request

Book a pharmaceutical demo.

Tell us about your SKUs, volumes and markets. An enterprise solutions engineer with deep pharmaceutical experience will get back within one business day.

45-minute technical walkthrough
ROI model tailored to your pharmaceutical SKU mix
Reference customers in pharmaceutical