Dashboard
Drug Portfolio
Tariff Monitor
✦ AI Substitutions
Supplier Network
Regulatory
Alerts
Margin at Risk
—
Annual impact
Products Affected
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of total portfolio
Substitutions Found
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AI-identified
Filed / Approved
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FDA amendments
Critical Alerts
—
Require action
Critical Products — Immediate Action
| Product | Key API | Origin | Tariff | Annual Impact | Risk | |
|---|---|---|---|---|---|---|
Tariff Exposure by Country
✦ AI Alerts —
Recent AI Analyses
| Product | Line | NDC | Key API | Origin | Tariff | Annual Impact | Risk | |
|---|---|---|---|---|---|---|---|---|
Live tariff monitoring active. Tracking CBP, WTO, USTR databases. China 145% Section 301 active. India 26.6% Section 301 active. Pending: India escalation to 60% (H2 2025).
Active Tariff Rates
| Country | Rate | Type | Effective | APIs Hit |
|---|---|---|---|---|
Pending / Proposed Changes
| Country | Proposed Rate | Status | Expected |
|---|---|---|---|
COGS Exposure — Critical Products
| Product | API | Origin | Tariff | Base COGS | Tariff COGS | Delta/Unit | Annual Impact | Risk |
|---|---|---|---|---|---|---|---|---|
AI Substitution Engine — Claude AI analyzes 2.4M+ pharmacopeia ingredient pairs to find ranked alternatives with regulatory pathway predictions.
New Analysis Request
Requires ANTHROPIC_API_KEY — typically 10–30 seconds
Past Analyses
✦
Select a product and ingredient to run AI analysis
Claude AI will search pharmacopeias and predict regulatory pathways for substitution candidates.
Max Risk: 100
| Supplier | Country | Quality | DMF | Capacity | APIs Supplied | Incidents | Risk Score | |
|---|---|---|---|---|---|---|---|---|
Regulatory Pathway AI predicts FDA CBE-0 / CBE-30 / PAS filing type and EMA variation type for each approved substitution. All recommendations require RA team review before filing.
Active Filings
| Product | Type | Jurisdiction | Status | Filed | AI Confidence |
|---|---|---|---|---|---|
Pathway Decision Guide (FDA)
CBE-0 — Implement Immediately
Same pharmacopoeial grade, equivalent spec, same ingredient class, no bioequivalence risk. Notify FDA post-implementation. Best path for highest-volume generics.
CBE-30 — 30-Day Wait
Minor pharmaceutical risk, different qualified manufacturer for same API. Submit 30 days before implementation. FDA has 30 days to object.
PAS — Prior Approval Required
Any change with potential impact on BE/safety/efficacy. Full FDA review required. Average 10–12 months. Required for complex molecules, biosimilars.
System Alerts