Country · Latin America
Pharmaceutical exports to Panama, ready for DNFD registration
Progene Pharma supplies Panamanian 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 National Directorate of Pharmacy and Drugs asks for, pack in Spanish, and ship to Colón and Balboa.
- Regulator
- National Directorate of Pharmacy and Drugs
- Labels
- Spanish
- Stability
- Zone IVb, 30 °C / 75% RH
- Main ports
- Colón, Balboa
The Panamanian medicines market in brief
Panama is a small, high-income market that uses the US dollar and sits at the crossroads of the Americas. Its ports and the Colón Free Zone make it a distribution hub, and many distributors hold stock there for sale across Central America and the Caribbean.
Chronic care medicines for diabetes, high blood pressure and heart disease sell in large volumes, alongside antibiotics, pain medicines, gastric products and supplements. The social security fund and the Ministry of Health buy for public hospitals through tenders, and private hospitals, pharmacy chains and distributors buy alongside them.
The DNFD registers medicines and requires evidence of GMP compliance. A registered product can be sold across the country and supplied onward through regional distributors.
Medicines we supply to Panama
These are the medicines Panamanian 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 Panama City, Colón and David.
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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.
DNFD registration, step by step
A medicine cannot be imported or sold in Panama until the National Directorate of Pharmacy and Drugs (DNFD) has granted a sanitary registration. 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 established in Panama that holds the right licences, usually the importer or distributor, acting for the manufacturer. It applies to the DNFD.
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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 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
DNFD reviews it
The DNFD assesses the dossier and may ask questions, which we answer with you. A generic may need bioequivalence data.
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05
GMP evidence and samples
The DNFD 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 DNFD issues a sanitary registration, valid for a fixed period and renewed before it expires. The registration number goes on every pack.
Registration takes from several months to more than a year, and DNFD updates its requirements from time to time, so check the current guidelines with DNFD or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Panama
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The DNFD application, as the registration holder
- The licences your business needs to import and distribute medicines
- Bioequivalence studies for generics, where the DNFD asks for them
- The import documents and customs declaration, through your customs agent
- Payment, and clearance at the port or the free zone
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 sanitary registration number
- Invoice, packing list and certificate of origin
- Answers to DNFD's questions during review
Made for Panamanian 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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Labels in Spanish
Cartons and patient leaflets in Spanish, with the generic name, the sanitary registration number, batch number, expiry date and storage conditions the DNFD requires, and an approved proof before printing.
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Stability for your zone
Stability studies at the climate zone the DNFD requires, with moisture-resistant blisters or bottles, so the shelf life on the pack is valid.
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Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities pharmacies, distributors and public hospitals buy.
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Packs for regional supply
Labelling and documents prepared so a distributor in Panama can supply neighbouring countries once those registrations are in place.
Shipping to Panama
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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Colón
Panama's Atlantic port, with the Colón Free Zone beside it
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Balboa
The Pacific port at the canal, a short road from Panama City
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Panama City
By air to Tocumen 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, and the import documents and customs declaration from your side
Where Panamanian distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public health supply
The social security fund and the Ministry of Health buy for public hospitals through tenders and ask for the full document set.
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Pharmacy chains
Pharmacy chains buy in volume and sell branded and own-label generics.
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Private hospitals and clinics
Private hospital groups and clinics buy in hospital packs, often through group contracts.
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Regional distributors
Distributors in Panama and the Colón Free Zone supply neighbouring countries and need consistent labelling and documents.
Questions about supplying Panama
Something else? Email [email protected].
Do you export medicines to Panama?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Panama.
Can you help us register products with DNFD?
Yes. Progene Pharma prepares the documents DNFD registration needs: a CTD dossier with stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Panamanian company submits the application, and we answer DNFD's questions with you.
Do I need a local company to register and import?
Yes. The DNFD grants a sanitary registration to a company established in Panama that holds the right licences, usually the importer or distributor. Check the current requirements with the DNFD.
How long does DNFD 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 DNFD's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does DNFD ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. DNFD updates its requirements from time to time, so confirm the current list with DNFD or your regulatory agent. We tell you what we can provide with your quotation.
Can a Panamanian distributor supply other countries?
Many do, because Panama's ports and free zone make it a regional hub. Each destination country still registers the medicine itself, so tell us the countries you plan to sell in and we will confirm the documents each one needs.
Does Panama use the US dollar?
Yes. Panama uses the US dollar alongside its own balboa coins, which keeps payment straightforward, and we quote in US dollars as usual.
Can you supply the social security fund and the Ministry of Health?
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 Panama?
Spanish text, the DNFD sanitary registration number, batch number, manufacture and expiry dates, storage conditions and the other details DNFD 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 climate zone your authority requires and packs them in moisture-resistant blisters or bottles, so the shelf life stays valid.
Can you supply tenders in Panama?
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 Panama?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Colón or Balboa, or by air to Panama City 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.
Related pages
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