How Companies in Egypt Can Source Pharma Products & CDMO Services from India

Egypt is one of the largest pharmaceutical markets within the Middle East and North Africa (MENA) region. The continued rapid growth of its population has resulted in an increased need for chronic disease treatments and a thriving local manufacturing environment. While Egypt continues to significantly rely on the importation of Active Pharmaceutical Ingredients (API's), finished formulations, and hospital products, this current environment has proven to be very beneficial for the Egyptian Pharmaceutical industry to work with companies in India.

India is considered one of the most trusted sourcing partners for Egyptian importers/distributors. With its facilities being WHO-GMP and EU-GMP certified along with their impressive large-scale production capabilities for API's and low costs, Indian suppliers provide Egyptian pharmaceutical companies a level of assurance for a steady supply of product at a competitive price point. This guide will help Egyptian importers/distributors of pharmaceuticals and CDMO services from India to do so compliantly and with minimal disruption.

Why Egyptian Companies Source Pharmaceuticals From India

1. Strong regulatory compliance

Many Indian manufacturers are certified by:

• WHO-GMP
• EU-GMP
• USFDA
• MHRA
• TGA

This ensures quality aligned with Egyptian Drug Authority (EDA) expectations.

2. Competitive pricing

Indian producers offer 30–50% lower costs for many therapeutic categories. This helps Egyptian companies stay competitive in retail and tender markets.

3. Wide product availability

India supplies nearly all medicine categories required in Egypt:

• Cardiovascular
• Diabetes
• Gastrointestinal
• Antibiotics
• Oncology (selected injectables)
• OTC & nutraceuticals
• APIs for local formulation

4. Strong experience with EDA documentation

Indian exporters understand:

• Dossier formats
• Packaging rules
• Lab sample requirements
• Import registration rules

5. Reliable supply infrastructure

India’s large manufacturing scale ensures steady supply even during peak demand.

What Egypt Commonly Imports From India

1. APIs for local production

Egypt has a strong domestic manufacturing industry, and API imports from India support:

• Tablets
• Capsules
• Syrups
• Injectables

Major APIs include:

• Atorvastatin
• Metformin
• Pantoprazole
• Amoxicillin
• Azithromycin
• Cefuroxime
• Diclofenac

2. Finished Pharmaceutical Products

• Solid orals
• Liquids and suspensions
• Pediatric formulations
• OTC
• Pain management
• GI medicines

3. Injectables

India supplies:

• Oncology injectables
• Antibiotic vials
• IV fluids
• Lyophilized products

4. Nutraceuticals & Herbal Products

Strong demand categories include:

• Vitamins
• General wellness
• Immunity products
• Herbal formulations

5. Medical & Hospital Consumables

• Disposable syringes
• IV sets
• Gloves
• Bandages

Step-by-Step: How Egyptian Companies Can Source From India

Step 1: Identify your sourcing requirement

Include:

• Molecule
• Strength
• Dosage form
• Pack size
• Expected volume
• Registration status (registered/unregistered)

Step 2: Shortlist Indian manufacturers

Prioritize companies with:

• WHO-GMP/EU-GMP
• Prior exports to Egypt or MENA
• Strong regulatory track record

Step 3: Request regulatory files

Documents include:

• COA
• GMP
• COPP
• Stability data
• Batch MFR record
• CTD dossier (if registering with EDA)

Step 4: Prepare EDA submission

Egypt Drug Authority requires:

• Full CTD dossier
• Stability data (Zone IV)
• Samples for quality checks
• Approved artwork in Arabic & English

Step 5: Finalize pricing & supply terms

Discuss:

• MOQ
• Price (FOB, CIF)
• Payment terms
• Private labeling options
• Delivery timelines

Step 6: Plan logistics & import timeline

Choose sea freight for bulk shipments and air freight for urgent supplies.

Logistics From India to Egypt

India has strong shipping connectivity to Egypt through both sea and air routes.

Major Export Ports in India

• Nhava Sheva (Mumbai)
• Mundra
• Chennai
• Cochin
• Hyderabad & Delhi airports

Shipping Timelines

Air Freight:

• 3–6 days (Mumbai → Cairo)
• Best for injectables, APIs, urgent deliveries

Sea Freight:

• 15–25 days to Alexandria or Port Said
• Most economical for tablets, capsules, syrups, OTC products

Legal & Regulatory Overview (Egypt – EDA)

The Egyptian Drug Authority (EDA) regulates the importation of pharmaceuticals into Egypt from abroad; thus, Indian exporters understand these regulations.

1. Product Registration Process

EDA may require:

• Full CTD dossier
• GMP certificate
• COPP
• DMF for APIs
• Stability data
• Samples for testing
• Packaging & artwork approval

2. Variations & Renewal

Any change in:

• API source
• Packaging
• Strength
• Requires variation filing.
• Products must be renewed every registration cycle.

3. Local Representative

Most imports require an Egyptian agent or legal representative.

4. Labeling Requirements

Labels must include:

• Batch number
• Mfg/Exp dates
• Storage conditions
• EDA-approved artwork
• Arabic-English text

5. Documentation Support

Indian suppliers commonly provide:

• Quality files
• Validation documents
• Stability studies
• Risk management reports

✅ Best Practices for Egyptian Buyers

• Verify EU-GMP status
• Request last audit report
• Review quality systems
• Run a small pilot batch
• Set clear timelines and SOPs
• Consider dual sourcing for risk control

These steps help ensure long-term, stable partnerships.

Indian producers are reliable and cost-effective partners for the Egyptian Pharmaceutical industry. With their WHO-GMP and EU-GMP certified facilities, competitive pricing, wide range of products, and strong regulatory support systems, Indian producers provide the Egyptian Pharmaceutical market with the means to continue to develop and expand.

Indian pharmaceutical suppliers offer Egypt exceptional value, and the ability to support the continued growth of the Egyptian Pharmaceutical market, whether it be through the importation of API's, generic formulations, injectable products, OTC (over-the-counter) drugs, or bespoke (custom developed) products.

1. Can Egyptian companies import directly from Indian manufacturers?

Yes. India is one of Egypt’s largest pharma suppliers.

2. Do Indian exporters support EDA documentation?

Most provide CTD dossiers, COPP, stability data, and GMP certificates.

3. What is the typical lead time for manufacturing?

• Finished formulations: 4–8 weeks
• Injectables: 8–12 weeks
• APIs: 2–6 weeks

4. Do products require Arabic labels?

Yes. EDA requires bilingual (Arabic + English) labeling.

5. Are Indian medicines acceptable for public and private tenders?

Yes. Many tender-winning products are sourced from Indian manufacturers.

6. What are typical MOQs?

• Tablets: 100k–300k units
• Injectables: 5k–20k vials
• APIs: 25–100 kg

7. How long does shipping take?

• Air: 3–6 days
• Sea: 15–25 days

8. Can Indian CDMOs manufacture private-label products for Egypt?

Yes. Many Indian CDMOs specialize in private-label and custom formulations.