Market
Pharmaceutical exports to Latin America, ready to register
Progene Pharma supplies distributors, importers, hospital suppliers and tender suppliers across Mexico, Central America, the Andean region, Brazil and the Southern Cone with generic medicines we manufacture in a WHO-GMP certified facility. Labelled in Spanish or Portuguese, tested for your climate zone, and sent with the dossier your national authority asks for.
- Regions
- Mexico to the Southern Cone
- Labels
- Spanish, Portuguese, English
- Stability
- Zone IVa or IVb, by country
- Dossiers
- CTD, with country requirements
Why Latin American distributors choose Progene Pharma
Progene Pharma makes the same molecules as the original brands, to the same pharmacopoeia standards, at a fraction of the price. Our facility is WHO-GMP certified, the standard national authorities in the region look for first, and also holds EU-GMP and ISO certification.
We ship by sea from Nhava Sheva (JNPT), near Mumbai, to Santos, Callao, Cartagena and other regional ports, and by air for urgent orders. We prepare the dossier and certificates your authority needs, and your company, as the local holder, files them.
Medicines we supply to Latin America
These are the products Latin American 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
Analgesics, antihistamines, gastric medicines and everyday prescription generics in the strengths and packs pharmacies sell.
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Antibiotics and antiparasitics
Amoxicillin, azithromycin, ciprofloxacin, albendazole, ivermectin and metronidazole for clinics, pharmacies and public programmes.
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Diabetes and heart care
Metformin, glimepiride, amlodipine, losartan and statins, as long-term conditions account for a growing share of prescriptions across the region.
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Hospital and tender supplies
IV fluids, injectable antibiotics, anaesthetics and analgesics in hospital packs for government institutes and regional purchasing programmes.
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Veterinary medicines
Injectables, boluses, oral liquids and premixes for the cattle, poultry and pet markets of Brazil, Argentina and neighbouring countries.
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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.
Medicine regulators in Latin America
Each country registers medicines through its own regulator. These are the authorities in the largest markets; we prepare dossiers in the formats they expect.
Mexico, Central America and the Caribbean
- Mexico
- Federal Commission for the Protection against Sanitary Risk (COFEPRIS)
- Guatemala
- Ministry of Public Health and Social Assistance
- Costa Rica
- Ministry of Health
- Panama
- Dirección Nacional de Farmacia y Drogas
- Dominican Republic
- Dirección General de Drogas y Farmacias
Andean region
Registration in Latin America is strict and local. Most countries register a medicine to a company established in the country, and some, such as Brazil, certify foreign manufacturing sites before they approve a product. Several regional bodies work towards shared standards, but each country still decides for itself. Rules differ by country, so check with your authority.
How registration usually works
Registration can take from several months to well over a year depending on the country, so many distributors register a few products first and add more as orders grow.
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01
Appoint a local holder
A medicine is registered to a company established in the country, usually the distributor or importer, which holds the registration and deals with the authority.
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02
Submit the dossier
We prepare the CTD dossier, the COPP, the GMP certificate and samples, and your team files them with the authority, with any data it asks for on interchangeability or bioequivalence.
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03
Review and site certification
The authority reviews the dossier, tests samples and, in some countries, certifies the manufacturing site from its documents or after an inspection.
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04
Approval and import
Once approved, the registration number goes on the pack and each shipment is imported against the permits your country requires.
Made for Latin American 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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Spanish and Portuguese labels
Cartons and leaflets in Spanish, or in Portuguese as written for Brazil, with the registration number, batch details and storage conditions your authority requires.
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Stability for your zone
Stability studies at the hot and humid conditions your authority asks for, Zone IVa (30 °C and 65% relative humidity) or Zone IVb (30 °C and 75%), so the shelf life on the pack holds up.
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Packs for the local rules
Cartons and blisters laid out to each country's labelling standards, with room for the track-and-trace code that some countries, such as Brazil and Argentina, require.
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Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities government institutes and pharmacy chains buy.
Shipping to Latin America
Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your customs broker needs.
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Brazil and the Southern Cone
Santos, Buenos Aires, Montevideo and Valparaíso, with onward road freight
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Andean region
Callao, Guayaquil and Cartagena
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Mexico and Central America
Manzanillo, Veracruz and Colón
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Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin, COA and consularised or legalised documents where required
Questions about supplying Latin America
Something else? Email [email protected].
Do you export medicines to Latin America?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to distributors, importers, hospital suppliers and tender suppliers in Mexico, Central America, the Andean region, Brazil and the Southern Cone.
Can you help us register products with COFEPRIS, ANVISA or INVIMA?
Yes. Progene Pharma prepares the documents registration needs: a CTD dossier with stability data, the WHO-format COPP, the GMP certificate and samples for testing. Your company, as the local holder, files them with the authority, and we answer its questions with you.
Do you supply packs labelled in Spanish or Portuguese?
Yes. Progene Pharma prints cartons, labels and patient leaflets in Spanish, in Portuguese for Brazil, or in English or another language, to match your registration.
Does ANVISA certify your manufacturing site?
Some authorities, Brazil's ANVISA among them, certify foreign manufacturing sites before approving a product, either from documents or after an inspection. We supply the site documents and certificates, and your team confirms the process with the authority.
Are your medicines suitable for hot, humid climates?
Yes. Products for Latin American markets are tested at the hot and humid conditions your authority asks for, Zone IVa or Zone IVb, and packed in moisture-resistant blisters or bottles, so the shelf life stays valid.
Do I need a local company to import medicines?
In most Latin American countries, yes. A medicine is registered to a licensed local company, usually the importer or distributor, which then imports each shipment against the permits required. Rules differ by country, so check with your authority.
Can you supply government and hospital tenders?
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 Latin America?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to ports such as Santos, Buenos Aires, Callao, Cartagena and Manzanillo, or by air for urgent orders, on FOB, CFR or CIF terms.
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.
Explore more
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