Country · Africa
Pharmaceutical exports to Egypt, ready for EDA registration
Progene Pharma supplies Egyptian importers, distributors, hospital suppliers and tender suppliers with generic medicines we manufacture in a WHO-GMP certified facility. We prepare the dossier, the COPP and the samples the Egyptian Drug Authority asks for, label in Arabic and English, and ship to Alexandria, Port Said and Sokhna.
- Regulator
- Egyptian Drug Authority
- Labels
- Arabic and English
- Stability
- Zone IV, as the EDA requires
- Main ports
- Alexandria, Port Said, Sokhna
The Egyptian medicines market in brief
Egypt is the most populous country in the Arab world and one of the largest pharmaceutical markets in Africa and the Middle East. It has a very large local generics industry that supplies most of the medicines used, so imports concentrate on products the local industry does not make, specialised forms and hospital supplies.
Chronic care medicines for diabetes, high blood pressure, heart disease and liver disease sell in very large volumes, alongside antibiotics, pain medicines, gastric products and supplements. A universal health insurance system is being rolled out in stages, which is widening access to medicines.
Public purchasing is centralised through the Unified Procurement Authority, which buys for government hospitals, while private pharmacies, hospital groups and distributors buy alongside it. The EDA sets the price of each registered medicine, and registration policy favours local manufacturing, so imported products need a clear place in the market.
Medicines we supply to Egypt
These are the medicines Egyptian distributors ask us for most. We make any human formulation to your specification, under your brand. See all human formulations
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Generic medicines for pharmacies
Analgesics, antihistamines, gastric medicines and everyday prescription generics in the strengths and packs pharmacies sell.
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Antibiotics and infections
Amoxicillin, amoxicillin and clavulanic acid, azithromycin, ciprofloxacin, cefixime and ceftriaxone injection, for clinics and hospitals.
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Pain and fever
Paracetamol, ibuprofen and diclofenac in tablets, suspensions and injections.
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Diabetes and heart care
Metformin, glimepiride, amlodipine, losartan and atorvastatin, as long-term conditions become a larger share of prescriptions in Cairo, Alexandria and Giza.
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Stomach and allergy
Omeprazole, pantoprazole, cetirizine, montelukast and cough syrups, for everyday pharmacy sale.
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Hospital and tender supplies
IV fluids, injectable antibiotics, anaesthetics and analgesics in hospital packs for tenders.
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Vitamins and supplements
Multivitamins, vitamin D3, omega-3, probiotics and protein products for pharmacies, health stores and online sellers.
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Herbal and personal care
Herbal products, creams, washes, shampoos and soaps under your brand, with the ingredient lists your authority requires.
EDA registration, step by step
A medicine cannot be imported or sold in Egypt until the Egyptian Drug Authority (EDA) has registered it. This is the usual route for a finished pharmaceutical product made abroad.
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01
A local company applies
The registration is held through a company in Egypt that is licensed to register and import medicines, acting as the local agent of the manufacturer. It applies to the EDA.
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02
The manufacturer authorises it
The manufacturer gives the applicant a letter of authorisation that names the product and the company, which we provide.
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03
The dossier goes in
The applicant submits the CTD dossier with stability data for the required climate zone, the WHO-format COPP, the GMP certificate and the samples, with documents legalised where required. We prepare the manufacturer's documents.
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04
EDA reviews it
The EDA assesses the dossier, including whether a local equivalent exists, and may ask questions, which we answer with you. Some generics also need bioequivalence data.
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05
GMP evidence and samples
The EDA checks that the manufacturing site complies with GMP, from the documents or an inspection, and may test samples.
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06
Registration and renewal
On approval the EDA issues a registration, sets the price and issues a registration number, which goes on every pack. The registration is valid for a fixed period and is renewed before it expires.
Registration takes from several months to more than a year, and EDA updates its requirements from time to time, so check the current guidelines with EDA or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Egypt
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The EDA application, through a licensed Egyptian agent
- The licences your business needs to import and distribute medicines
- Bioequivalence studies for generics, where the EDA asks for them
- The import approval and customs declaration, through your clearing agent
- Price approval with the EDA
Progene Pharma handles
- The CTD dossier, stability data and samples
- The COPP, the GMP certificate and the letter of authorisation
- A Certificate of Analysis for every batch
- Labels and leaflets with your registration number
- Invoice, packing list and certificate of origin
- Answers to EDA's questions during review
Made for Egyptian conditions
Heat, humidity, long journeys and several languages: what a medicine needs to stay good from the port to the patient.
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Arabic and English labels
Cartons and patient leaflets in Arabic and English, with the registration number, batch number, expiry date and storage conditions the EDA requires, and an approved proof before printing.
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Tested for heat
Stability studies at the hot climate conditions the EDA requires, with moisture-resistant blisters and bottles, so the shelf life holds up in Egyptian summers.
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Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities hospitals, pharmacies and the unified procurement buy.
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Documents that suit legalisation
Certificates and documents prepared so they can be legalised by the chamber of commerce and the embassy where Egypt requires it.
Shipping to Egypt
Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your clearing agent needs.
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Alexandria
Egypt's main Mediterranean port, with road freight to Cairo
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Sokhna and Port Said
Red Sea and Suez Canal ports, close to Cairo, for goods arriving from India
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Cairo
By air to Cairo International Airport for urgent orders and samples
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Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, legalised documents where required, and the import approval and customs declaration from your side
Where Egyptian distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Unified public procurement
The Unified Procurement Authority buys for government hospitals through tenders, and asks for the full document set.
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Private hospital groups
Private hospital groups buy in hospital packs, often through group contracts.
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Pharmacies and chains
Pharmacy chains and independent pharmacies sell branded packs of everyday generics and supplements.
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Distributors
Licensed distributors in Cairo and Alexandria supply pharmacies and hospitals across the country.
Questions about supplying Egypt
Something else? Email [email protected].
Do you export medicines to Egypt?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Egypt.
Can you help us register products with EDA?
Yes. Progene Pharma prepares the documents EDA registration needs: a CTD dossier with stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Egyptian company submits the application, and we answer EDA's questions with you.
Do I need a local company to register and import?
Yes. Egypt registers a medicine through a company in the country that is licensed to register and import medicines. Check the current requirements with the EDA.
How long does EDA registration take?
It varies by product and by how complete the dossier is, from several months to more than a year. A complete dossier with clear stability data and prompt answers to EDA's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does EDA ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. EDA updates its requirements from time to time, so confirm the current list with EDA or your regulatory agent. We tell you what we can provide with your quotation.
Does Egypt allow imported generics?
Yes, but registration policy favours local manufacturing, so imported products fit best where there is no local equivalent, or where the product is a specialised form or a hospital supply. Tell us the product and we will say how it fits.
Does the EDA set the price?
Yes. The EDA sets the price of each registered medicine as part of registration, so the distributor's price and margin are agreed with that in mind.
Can you supply the Unified Procurement Authority?
Yes. Progene Pharma supplies tender packs and the product documents public tenders usually ask for. Tell us the tender requirements and we will confirm what we can provide.
What must the packs carry for Egypt?
Arabic and English text, the EDA registration number, batch number, manufacture and expiry dates, storage conditions and the other details the EDA requires. We prepare the artwork to match your registration and you approve a proof before printing.
Are your medicines suitable for the climate?
Yes. Progene Pharma tests products at the hot climate conditions your authority requires and packs them in moisture-resistant blisters or bottles, so the shelf life stays valid.
Can you supply tenders in Egypt?
Yes. Progene Pharma supplies tender packs and the product documents tenders usually ask for, such as the COPP, GMP certificate and COA. Tell us the tender requirements and we will confirm what we can provide.
How are orders shipped to Egypt?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Alexandria, Port Said or Sokhna, or by air to Cairo for urgent orders, on FOB, CFR or CIF terms. We confirm the schedule with your quotation.
What is the minimum order quantity?
It depends on the product, the dosage form and the packaging. We work with large importers and tender suppliers as well as smaller distributors, and confirm the minimum quantity with your quotation.
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Send us your product requirements and target country. Our team will reply with a quotation and next steps.
- [email protected]
- Phone
- +91 22 49793146
- +91 90829 70494