Country · Middle East
Pharmaceutical exports to Saudi Arabia, ready for SFDA registration
Progene Pharma supplies Saudi 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 GMP evidence the Saudi Food and Drug Authority asks for, pack in Arabic and English, and ship to Jeddah and Dammam.
- Regulator
- Saudi Food and Drug Authority
- Labels
- Arabic and English
- Stability
- Zone IVb, 30 °C / 75% RH
- Main ports
- Jeddah, Dammam
The Saudi medicines market in brief
Saudi Arabia is the largest pharmaceutical market in the Gulf and one of the largest in the Middle East. It imports most of its medicines, and the government is encouraging local production, but demand for registered imports remains strong across the public and private sectors.
Diabetes, high blood pressure and heart disease are among the most common long-term conditions, so chronic care medicines such as metformin, amlodipine and atorvastatin sell in large volumes, alongside antibiotics, pain medicines and gastric products. Supplements and personal care products are also a large and growing market.
Public hospitals buy largely through national procurement, notably the National Unified Procurement Company (NUPCO), while private hospital groups, pharmacy chains and distributors buy alongside it. The SFDA sets the price of each registered medicine, so margins are agreed with the distributor's price in mind.
Medicines we supply to Saudi Arabia
These are the medicines Saudi 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 Riyadh, Jeddah and Dammam.
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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.
SFDA registration, step by step
A medicine cannot be imported or sold in Saudi Arabia until the Saudi Food and Drug Authority (SFDA) 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 by a company in Saudi Arabia that is licensed by the SFDA, usually the importer or distributor, acting as the local agent of the manufacturer. It applies to the SFDA.
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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 Zone IVb stability data, the WHO-format COPP, the GMP certificate, the samples and, for generics, the bioequivalence data the SFDA asks for. We prepare the manufacturer's documents.
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04
SFDA reviews it
The SFDA assesses the dossier and may ask questions, which we answer with you.
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05
GMP evidence and samples
The SFDA 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 SFDA issues a registration and sets the price. The product receives codes for the SFDA's drug tracking system, and the registration is renewed before it expires.
Registration takes from several months to more than a year, and SFDA updates its requirements from time to time, so check the current guidelines with SFDA or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Saudi Arabia
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The SFDA application, as the licensed Saudi agent
- The licences your business needs to import and distribute medicines
- Bioequivalence studies for generics, where the SFDA asks for them
- SFDA clearance of each shipment, and the customs declaration through your clearing agent
- Registration in the SFDA's drug tracking system
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 details
- Invoice, packing list and certificate of origin
- Answers to SFDA's questions during review
Made for Saudi 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 details, batch number, expiry date and storage conditions the SFDA requires, and an approved proof before printing.
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Track-and-trace codes
Space on the pack for the 2D barcode the SFDA requires for tracking each medicine through the supply chain, applied to match its system.
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Tested for heat
Stability studies at 30 °C and 75% relative humidity (Zone IVb), the condition the SFDA asks for, so the shelf life holds up in summer temperatures.
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Capsules to suit your customers
Vegetarian (HPMC) capsules as well as gelatin, where your customers or your authority prefer them.
Shipping to Saudi Arabia
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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Jeddah
Jeddah Islamic Port, the main port for the west and the route for most medicines
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Dammam
King Abdulaziz Port, for the east and the Gulf coast
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Riyadh
By road from the ports or the dry port, or by air to King Khalid International Airport
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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 SFDA clearance from your side
Where Saudi distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public hospitals and national procurement
Government hospitals buy largely through national procurement and ask for the full document set.
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Private hospital groups
Large private hospital groups buy in hospital packs, often through group contracts.
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Pharmacies and chains
National pharmacy chains and independent pharmacies want branded packs of everyday generics and supplements.
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Distributors
Licensed distributors in Riyadh, Jeddah and Dammam supply pharmacies and hospitals across the Kingdom.
Questions about supplying Saudi Arabia
Something else? Email [email protected].
Do you export medicines to Saudi Arabia?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Saudi Arabia.
Can you help us register products with SFDA?
Yes. Progene Pharma prepares the documents SFDA registration needs: a CTD dossier with stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Saudi company submits the application, and we answer SFDA's questions with you.
Do I need a local company to register and import?
Yes. The SFDA registers a medicine through a company in Saudi Arabia that holds the right licences, which then imports each shipment. Check the current requirements with the SFDA.
How long does SFDA 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 SFDA's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does SFDA ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. SFDA updates its requirements from time to time, so confirm the current list with SFDA or your regulatory agent. We tell you what we can provide with your quotation.
Does the SFDA require bioequivalence studies for generics?
For many generics, yes. The SFDA asks for bioequivalence data against a reference product, and sets rules on where the study may be done. Tell us the product and we will confirm what is needed before you apply.
Does the SFDA set the price?
Yes. The SFDA 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 NUPCO tenders?
Yes. Progene Pharma supplies tender packs and the product documents national tenders usually ask for. Send us the tender requirements and we will confirm what we can provide.
What must the packs carry for Saudi Arabia?
Arabic and English text, the SFDA registration details, batch number, manufacture and expiry dates, storage conditions, and the 2D barcode for the SFDA's tracking system. We prepare the artwork to match your registration and you approve a proof before printing.
Are your medicines suitable for the climate?
Yes. Products for this market are tested at 30 °C and 75% relative humidity (Zone IVb) and packed in moisture-resistant blisters or bottles, so the shelf life stays valid in hot conditions.
Can you supply tenders in Saudi Arabia?
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 Saudi Arabia?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Jeddah or Dammam, or by air to Riyadh or Jeddah 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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Request a quote
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