Export Solutions

Services & Technical Capabilities

Comprehensive pharmaceutical supply, regulatory documentation support, and international trade compliance designed for global healthcare partners.

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API & Raw Material Sourcing

Direct procurement of high-purity Active Pharmaceutical Ingredients (APIs) such as IP/USP Etomidate and Mitomycin from audited WHO-GMP accredited manufacturing plants.

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CTD & eCTD Dossier Support

Expert compilation of Common Technical Document (CTD / eCTD) Module 3 quality data, analytical validation, stability data, and Drug Master File (DMF) support.

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International Trade & Export

End-to-end export administration including air/ocean freight logistics, customs declaration, Certificate of Origin (COO), and commercial invoice authentication.

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Formulation & Technical Guidance

Assistance with dosage form selection, dissolution profile evaluation, excipient compatibility, and secondary commercial packaging options.

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Quality Assurance & Batch Audit

Comprehensive Certificate of Analysis (COA) verification for every batch, residual solvent testing, heavy metal testing, and microbial limit testing.

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Cold-Chain & Specialized Storage

Temperature-sensitive handling (2°C-8°C refrigerated or 15°C-25°C controlled room temp) with real-time temperature data logging during transit.

Process

Our 4-Step Export Workflow

Structured execution ensuring regulatory precision and timely international delivery.

01

Requirement & COA Review

Client submits technical specification requirements. We review pharmacopeial grades (IP, USP, EP) and sample COAs.

02

Commercial Terms & Dossier

Finalize proforma invoice, payment terms, minimum order quantities (MOQ), and initiate CTD dossier package preparation.

03

Batch Testing & Packaging

Goods undergo final analytical quality clearance and are secured in export HDPE fiber drums or moisture-proof blister packs.

04

Customs Clearance & Freight

Dispatch via air/sea freight with authenticated customs paperwork, temperature logger tracking, and airway bill notification.

FAQ

Capabilities & Technical FAQ

What regulatory documentation is provided with API orders? ▼

All commercial API orders (such as IP/USP Etomidate API Powder and Mitomycin API Powder) are accompanied by a comprehensive Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Stability Data summary, and CTD Module 3 technical documentation.

How are temperature-sensitive APIs handled during export shipping? ▼

Sensitive raw materials requiring cold-chain preservation (e.g., refrigerated 2°C–8°C storage) are packaged in validated insulated thermal shippers with temperature data loggers to monitor thermal integrity throughout international air transit.

Can Jani Pharma assist with country-specific drug registration filings? ▼

Yes. Our Regulatory Affairs team, headed by Dr. Sanjay Patel, provides CTD and eCTD dossier formatting, technical query responses, and documentation alignment for Ministry of Health registrations worldwide.