M1
Module 1 - Administrative
Country-adapted SmPC, package leaflet, labels, application forms, GMP & CoPP, manufacturer letter, declarations.
Regulatory
Request DEFRATAJ CTD Dossier
Country-ready CTD / eCTD / ACTD dossier packs for Deferasirox 125 / 250 / 500 mg dispersible and film-coated tablets. DMF + CoPP + GMP + BA/BE bundled. Confidentiality (MSA/NDA) standard.
60+
Countries served
19+
Active registrations
7-10
Days to initial pack
NDA + MSA
Confidentiality standard
Response within 24 business hours · Mon-Sat, 09:30 - 18:30 IST · info@tajpharma.com
What ships in your dossier
Six tightly-organised parts mapped to ICH M4 - ready for SAHPRA, NAFDAC, PPB, MOHAP, ANVISA, COFEPRIS and similar regulators.
M2
Module 2 - Summaries
Quality Overall Summary, Non-Clinical & Clinical Overviews and Summaries (CTD QOS, NCO, COS, NCS, CCS).
M3
Module 3 - Quality (CMC)
Full DS & DP CMC: specifications, methods, validation, stability (ICH zone IVa/IVb), container-closure, batch analysis.
M4
Module 4 - Non-Clinical
Non-clinical references and study reports per ICH M4S - pharmacology, pharmacokinetics, toxicology (bibliographic where applicable).
M5
Module 5 - Clinical
Pivotal BE study summary vs. EU innovator, clinical references, periodic safety update reports (PSUR/PBRER).
M+
Support pack
DMF letter of access, CoPP (country-addressed), WHO-cGMP certificate, BA/BE study, artwork files, undertakings.
From inquiry to approval
A predictable five-step path. We commit timelines in writing and own regulator queries until your MA is granted.
-
01
Inquiry received
You submit this form. Our regulatory desk responds within 24 business hours with a scope and timeline.
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02
NDA & KYC
Mutual NDA / Material Supply Agreement signed. KYC + drug regulatory authority licence shared.
-
03
Dossier release
CTD pack delivered (7-10 business days). Country adaptation completes in 2-3 weeks.
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04
Submission support
We answer regulator queries, provide variations / amendments and country-specific addenda free of cost.
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05
Approval & supply
On MA approval, we activate commercial supply, life-cycle PV and renewal/variation support.
Where DEFRATAJ is already on the shelf
Active marketing authorisations across Africa, MENA, CIS, South & South-East Asia. Many more under review.
🇿🇦
South Africa
SAHPRA
🇳🇬
Nigeria
NAFDAC
🇰🇪
Kenya
PPB
🇺🇬
Uganda
NDA
🇹🇿
Tanzania
TMDA
🇬ðŸ‡
Ghana
FDA
🇪🇹
Ethiopia
EFDA
🇧🇩
Bangladesh
DGDA
🇱🇰
Sri Lanka
NMRA
🇲🇲
Myanmar
FDA
🇵ðŸ‡
Philippines
FDA
🇺🇿
Uzbekistan
MoH
🇰🇿
Kazakhstan
NCELS
🇧🇾
Belarus
CEM
🇮🇶
Iraq
KIMADIA
🇾🇪
Yemen
SBDMA
🇻🇳
Vietnam
DAV
🇰ðŸ‡
Cambodia
DDF
🇳🇵
Nepal
DDA
Need a country not listed? Submit the form above - we adapt the dossier to most regulators worldwide.
CTD Dossier Request - common questions
Standard technical dossier is provided free-of-cost to qualified distributors/MA-holders committing to commercial off-take. Country-specific adaptation and BE study recharges are agreed case-by-case.
Yes - labels, SmPC and PIL are localised (Arabic, French, Portuguese, Spanish, Russian, Vietnamese, Bahasa, Swahili, Amharic) on request.
A US-DMF / EU-ASMF-style API dossier is available with letter of access. CEP is available for select APIs - confirm per strength.
We execute a mutual Confidentiality/Non-Disclosure Agreement and Material Supply Agreement (MSA) before sharing restricted CMC sections.
Pivotal BE study summary vs. EU innovator is included. Full study report is shared post-MSA.
Talk to a regulatory expert
Prefer a direct conversation?
Our export desk operates in IST. Call, WhatsApp or email - we'll route you to the right specialist within minutes.
Other ways to reach Taj Pharma Factory, corporate office, helpline, sales, export & HR
TAJ PHARMA INDIA LTD.
Your Trusted Healthcare Partner. Reach us through any of the channels below — the helpline operates in India Standard Time (IST).
Manufacturing Plant
Sarigam, Gujarat
Plot No. 1019, Vill. Sarigam, G.I.D.C., Road No. 10, Bhilad, Dist. Valsad, Gujarat, India 396155.
WHO-cGMP, GMP, GLP, EU-GMP, PIC/S, ISO 9001:2018, SGS approved.
Corporate Office
Andheri East, Mumbai
903-905, 9th Floor, The Avenue Bldg, International Airport Road, Andheri East, Mumbai 400 059, India.
+91 22 6973 8917 / +91 22 6919 8750
Fax: +91 22 2634 1274
Mon-Sat, 09:30 - 18:30 IST