A complete Common Technical Document (CTD) dossier is available for DEFRATAJ Deferasirox dispersible tablets to support product registration in target export markets. Dossier sharing is coordinated by our regulatory affairs team under a Confidentiality and Non-Disclosure Agreement.
Dossier Structure #
| Module | Contents | Prepared By |
|---|---|---|
| Module 1 - Administrative | Country-specific application forms, cover letters, labelling (SmPC, PIL, carton) | Country-specific (RA team can tailor for target market) |
| Module 2 - Summaries | QOS (Quality Overall Summary), Non-Clinical Overview, Clinical Overview, Clinical Summaries | Available |
| Module 3 - Quality | API data (3.2.S), Finished Product data (3.2.P), Appendices, Literature | Available (full) |
| Module 4 - Non-Clinical | Non-clinical study reports / literature references | Available (literature-based where appropriate) |
| Module 5 - Clinical | Clinical study reports / literature-based clinical summary; bioequivalence data | Available |
Bioequivalence & Clinical Package #
A comparative bioequivalence study versus the reference product supports the generic clinical package in Module 5. Additional clinical-literature summaries support the safety, efficacy and benefit-risk position of Deferasirox across indications (transfusional iron overload in thalassemia, SCD and MDS).
Country Formats Supported #
- WHO-PQ aligned national authorities (LATAM, Africa, Asia, CIS)
- ASEAN Common Technical Dossier (ACTD) - on request for relevant markets
- Country-specific eCTD where the regulator accepts eCTD format
- Module 1 localisation in EN / FR / PT / ES / AR (other languages on request)
Deficiency Response Support #
Registration is a dialogue - our regulatory affairs team responds to deficiency letters (DLs) and regulatory queries as part of the supply relationship. Turnaround on a typical deficiency is 10-20 business days depending on scope.
Post-Approval Variation Support #
After approval, we support Type IA / IB / II variations for manufacturing changes, specification updates, stability extensions, safety labelling updates and packaging changes - coordinated with the customer's local regulatory affairs function.
How to Request #
- Sign our standard CDA (or execute your own CDA - we are flexible)
- Indicate target country(ies), intended MAH (Taj Pharma or customer), required Module 1 language
- Dossier index and available data package typically shared within 5 business days of CDA execution