Progene Pharma

Country · Middle East

Pharmaceutical exports to Jordan, ready for JFDA registration

Progene Pharma supplies Jordanian 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 Jordan Food and Drug Administration asks for, label in Arabic and English, and ship to Aqaba and Amman.

Regulator
Jordan Food and Drug Administration
Labels
Arabic and English
Stability
Zone IVb, 30 °C / 75% RH
Main port
Aqaba

The Jordanian medicines market in brief

Jordan is a small market with an outsized pharmaceutical industry. It has a strong local generics sector that exports across the region, so the JFDA is an experienced regulator that expects complete, consistent dossiers and bioequivalence data for many generics. Imports serve products the local industry does not make.

Chronic care medicines for diabetes, high blood pressure and heart disease sell in large volumes, alongside antibiotics, pain medicines, gastric products and supplements. Jordan also hosts large numbers of refugees, whose health care is supported by international organisations that buy medicines in bulk.

Public hospitals and the military and university health systems buy through joint procurement and their own tenders, while private hospitals, pharmacy chains and distributors buy alongside them. The JFDA registers the price of each medicine, so margins are agreed with that in mind.

Medicines we supply to Jordan

These are the medicines Jordanian distributors ask us for most. We make any human formulation to your specification, under your brand. See all human formulations

  • Generic medicines for pharmacies

    Analgesics, antihistamines, gastric medicines and everyday prescription generics in the strengths and packs pharmacies sell.

  • Antibiotics and infections

    Amoxicillin, amoxicillin and clavulanic acid, azithromycin, ciprofloxacin, cefixime and ceftriaxone injection, for clinics and hospitals.

  • Pain and fever

    Paracetamol, ibuprofen and diclofenac in tablets, suspensions and injections.

  • Diabetes and heart care

    Metformin, glimepiride, amlodipine, losartan and atorvastatin, as long-term conditions become a larger share of prescriptions in Amman, Zarqa and Irbid.

  • Stomach and allergy

    Omeprazole, pantoprazole, cetirizine, montelukast and cough syrups, for everyday pharmacy sale.

  • Hospital and tender supplies

    IV fluids, injectable antibiotics, anaesthetics and analgesics in hospital packs for tenders.

  • Vitamins and supplements

    Multivitamins, vitamin D3, omega-3, probiotics and protein products for pharmacies, health stores and online sellers.

  • Herbal and personal care

    Herbal products, creams, washes, shampoos and soaps under your brand, with the ingredient lists your authority requires.

JFDA registration, step by step

A medicine cannot be imported or sold in Jordan until the Jordan Food and Drug Administration (JFDA) has registered it. This is the usual route for a finished pharmaceutical product made abroad.

  1. 01

    A local company applies

    The registration is held by a company in Jordan, usually the importer or agent, acting for the manufacturer. It applies to the JFDA.

  2. 02

    The manufacturer authorises it

    The manufacturer gives the applicant a letter of authorisation that names the product and the company, which we provide.

  3. 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 JFDA asks for. We prepare the manufacturer's documents.

  4. 04

    JFDA reviews it

    The JFDA assesses the dossier and may ask questions, which we answer with you.

  5. 05

    GMP evidence and samples

    The JFDA checks that the manufacturing site complies with GMP, from the documents or an inspection, and may test samples.

  6. 06

    Registration and renewal

    On approval the JFDA issues a registration, registers the price and issues a registration number, which goes on every pack. The registration is renewed before it expires.

Registration takes from several months to more than a year, and JFDA updates its requirements from time to time, so check the current guidelines with JFDA or your regulatory agent. Many importers register a few products first and add more as orders grow.

Who does what when you import into Jordan

A clear split of the paperwork, so nothing falls between the importer and the manufacturer.

Your company handles

  • The JFDA application, as the registered local agent
  • The licences your business needs to import and distribute medicines
  • Bioequivalence studies for generics, where the JFDA asks for them
  • The import permit and customs declaration, through your clearing agent
  • Price registration with the JFDA

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 JFDA's questions during review

Made for Jordanian conditions

Heat, humidity, long journeys and several languages: what a medicine needs to stay good from the port to the patient.

  • Arabic and English labels

    Cartons and patient leaflets in Arabic and English, with the registration number, batch number, expiry date and storage conditions the JFDA requires, and an approved proof before printing.

  • Tested for heat

    Stability studies at 30 °C and 75% relative humidity (Zone IVb), the condition regional authorities ask for, with moisture-resistant blisters and bottles.

  • Packs for every channel

    Pharmacy packs, hospital packs and tender packs in the quantities hospitals, pharmacies and humanitarian buyers purchase.

  • Documents that match the file

    The COA, the COPP and the GMP certificate are prepared to match the dossier exactly, because the JFDA reviews dossiers closely.

Shipping to Jordan

Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your clearing agent needs.

  • Aqaba

    Jordan's only seaport, on the Red Sea, with road freight to Amman and onward to Iraq

  • Amman

    By road from Aqaba, or by air to Queen Alia International Airport for urgent orders and samples

  • Transit

    By road to Iraq and the Levant, for distributors who supply them from Jordan

  • Terms and documents

    FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, and the import permit and customs declaration from your side

Where Jordanian distributors sell

The same registered product moves through several channels, and each needs its own pack.

Questions about supplying Jordan

Something else? Email [email protected].

Do you export medicines to Jordan?

Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Jordan.

Can you help us register products with JFDA?

Yes. Progene Pharma prepares the documents JFDA registration needs: a CTD dossier with Zone IVb stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Jordanian company submits the application, and we answer JFDA's questions with you.

Do I need a local company to register and import?

Yes. The JFDA registers a medicine through a company in Jordan, usually the importer or agent, which must also hold the licences to import and distribute medicines. Check the current requirements with the JFDA.

How long does JFDA 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 JFDA's questions helps. Many importers register a few products first and add more as orders grow.

Which documents does JFDA ask for?

The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. JFDA updates its requirements from time to time, so confirm the current list with JFDA or your regulatory agent. We tell you what we can provide with your quotation.

Does the JFDA require bioequivalence studies?

For many generics, yes. The JFDA asks for bioequivalence data against a reference product. Tell us the product and we will confirm what is needed before you apply.

Does the JFDA register the price?

Yes. The JFDA registers the price of each medicine as part of registration, so the distributor's price and margin are agreed with that in mind.

Can you supply public tenders in Jordan?

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 Jordan?

Arabic and English text, the JFDA registration number, batch number, manufacture and expiry dates, storage conditions and the other details the JFDA requires. 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, humid conditions.

Can you supply tenders in Jordan?

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 Jordan?

Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Aqaba, with onward road freight to Amman, or by air to Amman 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.

Request a quote

Send us your product requirements and target country. Our team will reply with a quotation and next steps.

Email
[email protected]
Phone
+91 22 49793146
WhatsApp
+91 90829 70494
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