Launching a private-label Deferasirox product is a multi-year commercial commitment. The quality of your manufacturing partner shapes your brand reputation, regulatory outcomes and supply reliability. Here is a due-diligence checklist.
1. Quality Due Diligence #
- Current WHO-GMP certificate with matching dosage form scope
- ISO 9001:2015 certification
- Audit readiness - can you conduct an on-site audit under CDA?
- Data-integrity posture (ALCOA+, audit trails, electronic records)
- Past regulatory-inspection outcomes
2. Regulatory Capability #
- CTD dossier maturity (Modules 1-5, including BE)
- Dossier localisation capability for your target market
- Responsiveness to deficiency letters (typical turnaround)
- Post-approval variation track record
3. Manufacturing Reliability #
- Dedicated oral-solids line vs shared
- Annual capacity for Deferasirox (strengths and total volume)
- Safety-stock and bridging-supply policy
- Lead-time commitments in writing
4. Commercial Terms #
- MOQ per SKU and annual minimums
- Pricing: ex-works, volume tiers, escalation clauses
- Payment terms (LC, TT, credit)
- Incoterms flexibility (FOB / CIF / DDP)
- Exclusivity / territorial rights
5. Risk Factors to Probe #
- Single-source API risk - is deferasirox API dual-sourced or backup-qualified?
- Freight / customs bottlenecks for your route
- Currency and payment-country constraints
- Pharmacovigilance agreement and local-authority reporting responsibilities
6. Recommended Process #
- CDA + initial technical and commercial dialogue
- Dossier sharing and desk review
- On-site audit (or virtual with documented evidence)
- Quality Agreement draft and MoU
- Final Master Supply and Quality Agreements
Taj Pharma offers private-label contract manufacturing - see Private Label Services.