Country · Latin America
Pharmaceutical exports to the Dominican Republic, ready for DGDF registration
Progene Pharma supplies Dominican 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 General Directorate of Drugs and Pharmacies asks for, pack in Spanish, and ship to Haina and Caucedo.
- Regulator
- General Directorate of Drugs and Pharmacies
- Labels
- Spanish
- Stability
- Zone IVb, 30 °C / 75% RH
- Main ports
- Haina, Caucedo
The Dominican medicines market in brief
The Dominican Republic is the largest economy in the Caribbean, with a growing middle class, strong tourism and a population that increasingly buys its medicines from pharmacies. It imports a large share of its medicines, and generics are widely sold.
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 and the national health insurance system buy through central tenders and the national programme for essential medicines, while private hospitals, pharmacy chains and distributors buy alongside them.
The DGDF registers medicines and requires evidence of GMP compliance. Importers in Santo Domingo hold the registrations and supply pharmacies, hospitals and the wider Caribbean market.
Medicines we supply to Dominican Republic
These are the medicines Dominican 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 Santo Domingo, Santiago and Punta Cana.
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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.
DGDF registration, step by step
A medicine cannot be imported or sold in the Dominican Republic until the General Directorate of Drugs and Pharmacies (DGDF) 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 the Dominican Republic that holds the right licences, usually the importer or distributor, acting for the manufacturer. It applies to the DGDF.
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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
DGDF reviews it
The DGDF 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 DGDF 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 DGDF 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 DGDF updates its requirements from time to time, so check the current guidelines with DGDF or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Dominican Republic
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The DGDF application, as the registration holder
- The licences your business needs to import and distribute medicines
- Bioequivalence studies for generics, where the DGDF asks for them
- The import documents and customs declaration, through your customs agent
- Payment, and clearance at the port
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 DGDF's questions during review
Made for Dominican 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 DGDF requires, and an approved proof before printing.
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Built for the climate
Stability studies at 30 °C and 75% relative humidity (Zone IVb), with moisture-resistant blisters and bottles, so the shelf life on the pack holds up in the tropical heat and humidity.
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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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Documents that match the file
The COA, the COPP and the GMP certificate are prepared to match the dossier exactly, because inconsistencies slow review.
Shipping to Dominican Republic
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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Haina
The main port of Santo Domingo, with road freight to the capital
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Caucedo
The container port east of Santo Domingo, with onward road freight
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Santo Domingo
By air to Las Américas 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 Dominican distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public health supply
Public hospitals and the national programme for essential medicines buy through central 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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Distributors
Distributors in Santo Domingo and Santiago supply pharmacies and hospitals across the country.
Questions about supplying Dominican Republic
Something else? Email [email protected].
Do you export medicines to Dominican Republic?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Dominican Republic.
Can you help us register products with DGDF?
Yes. Progene Pharma prepares the documents DGDF registration needs: a CTD dossier with stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Dominican company submits the application, and we answer DGDF's questions with you.
Do I need a local company to register and import?
Yes. The DGDF grants a sanitary registration to a company established in the Dominican Republic that holds the right licences, usually the importer or distributor. Check the current requirements with the DGDF.
How long does DGDF 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 DGDF's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does DGDF ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. DGDF updates its requirements from time to time, so confirm the current list with DGDF or your regulatory agent. We tell you what we can provide with your quotation.
Do generics need bioequivalence studies in the Dominican Republic?
For some generics, yes, depending on the product and the DGDF's current requirements. Tell us the product and we will confirm what is needed before you apply.
Can you supply Dominican public 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.
Can a Dominican distributor supply other Caribbean markets?
Some do. Each destination country registers the medicine itself, so tell us the countries you plan to sell in and we will confirm the documents each one needs.
What must the packs carry for Dominican Republic?
Spanish text, the DGDF sanitary registration number, batch number, manufacture and expiry dates, storage conditions and the other details DGDF 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 Dominican Republic?
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 Dominican Republic?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Haina or Caucedo, or by air to Santo Domingo 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