Country · Latin America
Pharmaceutical exports to Brazil, ready for ANVISA registration
Progene Pharma supplies Brazilian 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 ANVISA asks for, label in Portuguese, and ship to Santos and Paranaguá.
- Regulator
- ANVISA
- Labels
- Brazilian Portuguese
- Registration
- Ten years, then renewal
- Main ports
- Santos, Paranaguá
The Brazilian medicines market in brief
Brazil is the largest pharmaceutical market in Latin America and one of the largest in the world, with a population of more than two hundred million, a large public health system and a big private sector. Generics are well established, supported by law and by a distinctive generic mark on the pack.
Demand covers everyday generics, chronic care medicines for diabetes, high blood pressure and heart disease, antibiotics, pain medicines, gastric products and supplements. Prices are regulated by the government, and public procurement is among the largest in the world.
ANVISA is a demanding regulator. It reviews the dossier, requires bioequivalence data for generics and certifies foreign manufacturing sites, which can take a long time, so importers plan early and often register a few products first. The registration holder must be a Brazilian company with the right licences.
Medicines we supply to Brazil
These are the medicines Brazilian 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 São Paulo, Rio de Janeiro and Brasília.
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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.
ANVISA registration, step by step
A medicine cannot be imported or sold in Brazil until the National Health Surveillance Agency (ANVISA) has granted a 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 Brazil that has an ANVISA operating authorisation, usually the importer or distributor, acting for the manufacturer.
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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 in the format ANVISA requires, with stability data for the required climate zone, the WHO-format COPP, the GMP certificate and the samples. We prepare the manufacturer's documents.
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04
ANVISA reviews it
ANVISA assesses the dossier and may ask questions, which we answer with you. A generic also needs bioequivalence data from an accredited centre.
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05
Site certification
ANVISA certifies the manufacturing site for GMP, from the documents or an inspection, which can take a long time. We supply the site documents and certificates.
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06
Registration and renewal
On approval ANVISA issues a registration, valid for ten years and renewed before it expires. The registration number goes on every pack.
Registration takes from several months to more than a year, and ANVISA updates its requirements from time to time, so check the current guidelines with ANVISA or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Brazil
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The ANVISA application, as the registration holder
- The operating authorisation your business needs to import and distribute medicines
- Bioequivalence studies for generics
- Pricing under the government's price regulation
- The import licence, and customs clearance through a customs broker
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 ANVISA's questions during review
Made for Brazilian 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 Portuguese
Cartons and patient leaflets in Brazilian Portuguese, laid out to ANVISA's rules, with the registration number, batch number, expiry date and storage conditions, and the generic mark where it applies.
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Stability for your zone
Stability studies at the climate zone ANVISA requires, with moisture-resistant blisters or bottles, so the shelf life on the pack is valid.
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Track-and-trace
Space on the pack for the codes Brazil requires for tracking each medicine through the supply chain, applied to match its system.
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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 Brazil
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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Santos
Brazil's main port, with road freight to São Paulo and the south-east
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Paranaguá
A major southern port, for the south
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São Paulo
By air to Guarulhos 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 licence and customs declaration from your side
Where Brazilian distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public health purchasing
The Ministry of Health, states and municipalities buy for the public system through tenders, and ask for the full document set.
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Private hospitals
Private hospital groups buy in hospital packs, often through group contracts.
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Pharmacy chains
Large pharmacy chains sell branded and generic products, and want consistent quality and supply.
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Distributors
Licensed distributors supply independent pharmacies and clinics across the country.
Questions about supplying Brazil
Something else? Email [email protected].
Do you export medicines to Brazil?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Brazil.
Can you help us register products with ANVISA?
Yes. Progene Pharma prepares the documents ANVISA registration needs: a CTD dossier with stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Brazilian company submits the application, and we answer ANVISA's questions with you.
Do I need a local company to register and import?
Yes. ANVISA grants a registration to a company established in Brazil that holds an operating authorisation, and a licensed customs broker handles each import. Check the current requirements with ANVISA.
How long does ANVISA 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 ANVISA's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does ANVISA ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. ANVISA updates its requirements from time to time, so confirm the current list with ANVISA or your regulatory agent. We tell you what we can provide with your quotation.
Does ANVISA inspect foreign manufacturing sites?
ANVISA certifies foreign manufacturing sites for GMP, either from the documents or after an inspection, and the process can take a long time. We supply the certificates and site documents, and your team confirms the process with ANVISA.
Do generics need bioequivalence studies in Brazil?
Yes. A generic sold as interchangeable with the reference product needs bioequivalence data from an accredited centre. Tell us the product and we will confirm what is needed before you apply.
Are medicine prices regulated in Brazil?
Yes. The government regulates the prices of medicines, which affects what your distributor can charge, so agree your margins with the price regulation in mind.
What must the packs carry for Brazil?
Brazilian Portuguese text, the ANVISA registration number, batch number, manufacture and expiry dates, storage conditions and the other details ANVISA requires, and the generic mark where it applies. 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 Brazil?
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 Brazil?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Santos or Paranaguá, or by air to São Paulo 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