Country · Latin America
Pharmaceutical exports to Paraguay, ready for DINAVISA registration
Progene Pharma supplies Paraguayan 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 Sanitary Surveillance asks for, pack in Spanish, and ship through the River Plate ports.
- Regulator
- DINAVISA
- Labels
- Spanish
- Stability
- Climate zone set by the authority
- Main ports
- Montevideo, Buenos Aires, Paranaguá
The Paraguayan medicines market in brief
Paraguay is a landlocked country in the heart of South America. Its medicines arrive by sea at Buenos Aires, Montevideo or Paranaguá and then travel up the Paraná and Paraguay rivers or by road, so transit paperwork and a capable customs agent matter.
Chronic care medicines for diabetes, high blood pressure and heart disease sell alongside antibiotics, pain medicines, gastric products and supplements. Public hospitals and the social security institute buy through national tenders, while pharmacy chains and private clinics buy through importers in Asunción and Ciudad del Este.
Paraguay is a member of Mercosur, but each medicine still needs its own sanitary registration from DINAVISA, which requires evidence of GMP compliance.
Medicines we supply to Paraguay
These are the medicines Paraguayan 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 Asunción, Ciudad del Este and Encarnación.
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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.
DINAVISA registration, step by step
A medicine cannot be imported or sold in Paraguay until National Directorate of Sanitary Surveillance (DINAVISA) 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 Paraguay that holds the right licences, usually the importer or distributor, acting for the manufacturer. It applies to DINAVISA.
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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
DINAVISA reviews it
DINAVISA 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
DINAVISA 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 DINAVISA 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 DINAVISA updates its requirements from time to time, so check the current guidelines with DINAVISA or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Paraguay
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The DINAVISA application, as the registration holder
- The licences your business needs to import and distribute medicines
- Bioequivalence studies for generics, where DINAVISA 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 DINAVISA's questions during review
Made for Paraguayan 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 DINAVISA requires, and an approved proof before printing.
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Stability for your zone
Stability studies at the climate zone DINAVISA 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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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 Paraguay
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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Buenos Aires and Montevideo
The usual routes, by sea and then by river or road to Asunción
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Paranaguá
The Brazilian port, an alternative route by road across the border
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Asunción
By air to Silvio Pettirossi 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 Paraguayan 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 social security institute buy through national 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 Asunción and Ciudad del Este supply pharmacies and hospitals across the country.
Questions about supplying Paraguay
Something else? Email [email protected].
Do you export medicines to Paraguay?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Paraguay.
Can you help us register products with DINAVISA?
Yes. Progene Pharma prepares the documents DINAVISA registration needs: a CTD dossier with stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Paraguayan company submits the application, and we answer DINAVISA's questions with you.
Do I need a local company to register and import?
Yes. DINAVISA grants a sanitary registration to a company established in Paraguay that holds the right licences, usually the importer or distributor. Check the current requirements with DINAVISA.
How long does DINAVISA 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 DINAVISA's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does DINAVISA ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. DINAVISA updates its requirements from time to time, so confirm the current list with DINAVISA or your regulatory agent. We tell you what we can provide with your quotation.
How do medicines reach Paraguay?
Paraguay is landlocked, so shipments go by sea to Buenos Aires, Montevideo or Paranaguá and then by river or road under a transit procedure. Your customs agent handles transit, and we confirm the schedule with your quotation.
Do generics need bioequivalence studies?
For some generics, yes, depending on the product and DINAVISA's current requirements. Tell us the product and we will confirm what is needed before you apply.
Can you supply Paraguayan 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.
What must the packs carry for Paraguay?
Spanish text, the DINAVISA sanitary registration number, batch number, manufacture and expiry dates, storage conditions and the other details DINAVISA 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 Paraguay?
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 Paraguay?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Buenos Aires or Montevideo, with river or road freight to Asunción, or through Paranaguá in Brazil, or by air to Asunción 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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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