Progene Pharma

Country · Middle East

Pharmaceutical exports to Oman, ready for Ministry of Health registration

Progene Pharma supplies Omani 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 Ministry of Health asks for, label in Arabic and English, and ship to Sohar, Muscat and Salalah.

Regulator
Ministry of Health
Labels
Arabic and English
Stability
Zone IVb, 30 °C / 75% RH
Main ports
Sohar, Muscat, Salalah

The Omani medicines market in brief

Oman is a Gulf market with a small population and a well-developed public health system. It imports almost all of the medicines it uses, and its ports at Sohar, Muscat and Salalah are close to India, which makes for short sea transit.

Chronic care medicines for diabetes, high blood pressure and heart disease sell in large volumes, alongside antibiotics, pain medicines, gastric products and supplements. Public hospitals buy most medicines through central tenders, and a growing private sector of clinics, hospitals and pharmacy chains buys through local agents.

A foreign manufacturer normally works through an Omani commercial agent, and products can also be registered under the Gulf Cooperation Council's central registration, which serves several member states.

Medicines we supply to Oman

These are the medicines Omani 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 Muscat, Sohar and Salalah.

  • 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.

MOH registration, step by step

A medicine cannot be imported or sold in Oman until the Ministry of Health 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 through an Omani company that holds the right licences, acting as the local agent of the manufacturer. It applies to the ministry.

  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 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.

  4. 04

    MOH reviews it

    The ministry assesses the dossier and may ask questions, which we answer with you. A product can also be registered through the Gulf Cooperation Council's central registration, which serves several member states.

  5. 05

    GMP evidence and samples

    The ministry 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 ministry issues a registration and 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 MOH updates its requirements from time to time, so check the current guidelines with MOH or your regulatory agent. Many importers register a few products first and add more as orders grow.

Who does what when you import into Oman

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

Your company handles

  • The Ministry of Health application, through a licensed Omani agent
  • The commercial agency agreement and the licences your business needs
  • The import permit for each consignment
  • The customs declaration, through your clearing agent
  • Pricing approval with the ministry, where it applies

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 MOH's questions during review

Made for Omani 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 ministry requires, and an approved proof before printing.

  • Tested for heat

    Stability studies at 30 °C and 75% relative humidity (Zone IVb), the condition the Gulf authorities ask for, so the shelf life holds up in summer temperatures.

  • Packs for every channel

    Pharmacy packs, hospital packs and tender packs in the quantities hospitals, pharmacy chains and central tenders buy.

  • Documents that suit legalisation

    Certificates and documents prepared so they can be legalised by the chamber of commerce and the embassy where Oman requires it.

Shipping to Oman

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

  • Sohar

    A deep-water port on the Gulf of Oman, with road freight to Muscat and into the UAE

  • Muscat and Salalah

    The capital's port and the southern container port, which serves the south and the region

  • Muscat

    By air to Muscat International Airport for urgent orders and samples

  • Terms and documents

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

Where Omani distributors sell

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

Questions about supplying Oman

Something else? Email [email protected].

Do you export medicines to Oman?

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

Can you help us register products with MOH?

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

Do I need a local company to register and import?

Yes. Oman registers a medicine through a company in the country that holds the right licences, acting as the manufacturer's commercial agent. Check the current requirements with the Ministry of Health.

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

Which documents does MOH ask for?

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

What is the GCC central registration?

It is a procedure of the Gulf Cooperation Council that lets one registration serve several member states. Tell us the countries you plan to sell in and we will confirm whether it suits the product.

Do I need an Omani commercial agent?

Yes. A foreign manufacturer works through a company in Oman that holds the right licences and acts as its agent for registration and distribution. Check the current requirements with the Ministry of Health.

Can you supply Omani government tenders?

Yes. Progene Pharma supplies tender packs and the product documents public 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.

What must the packs carry for Oman?

Arabic and English text, the ministry registration number, batch number, manufacture and expiry dates, storage conditions and the other details ministry 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 Oman?

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 Oman?

Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Sohar, Muscat or Salalah, or by air to Muscat 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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