Country · Latin America
Pharmaceutical exports to Argentina, ready for ANMAT registration
Progene Pharma supplies Argentine 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 ANMAT asks for, pack in Spanish, and ship to Buenos Aires.
- Regulator
- ANMAT
- Labels
- Spanish
- Prescribing
- By generic name
- Main port
- Buenos Aires
The Argentine medicines market in brief
Argentina has one of the larger pharmaceutical markets in Latin America, with a mix of national laboratories, which supply most of the market, and imported products. Doctors prescribe by generic name under national law, which favours generics and makes the active ingredient, not the brand, the main selling point.
Chronic care medicines for diabetes, high blood pressure and heart disease sell in large volumes, alongside antibiotics, pain medicines, gastric products and supplements. Large buyers include the national insurance programme for retirees, the provincial health systems and the social health insurance funds.
Importing is shaped by economic conditions that change often, including import licensing, currency rules and price controls, so payment terms and timing need early planning. ANMAT is a demanding regulator and inspects foreign manufacturing sites.
Medicines we supply to Argentina
These are the medicines Argentine 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 Buenos Aires, Córdoba and Rosario.
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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.
ANMAT registration, step by step
A medicine cannot be imported or sold in Argentina until the National Administration of Drugs, Foods and Medical Devices (ANMAT) has registered it. 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 pharmaceutical laboratory or importer established in Argentina that holds the right authorisations, 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 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
ANMAT reviews it
ANMAT assesses the dossier and may ask questions, which we answer with you. A generic also needs bioequivalence data where ANMAT requires it.
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05
Site inspection and samples
ANMAT checks that the manufacturing site complies with GMP and may inspect it, which can take time, and may test samples. We supply the site documents and certificates.
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06
Registration and renewal
On approval ANMAT issues a registration, which carries the number that goes on every pack. The registration is valid for a fixed period and is renewed before it expires.
Registration takes from several months to more than a year, and ANMAT updates its requirements from time to time, so check the current guidelines with ANMAT or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Argentina
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The ANMAT application, as the registration holder
- The authorisations your business needs to import and distribute medicines
- Bioequivalence studies, where ANMAT asks for them
- Import licensing and the customs declaration, through your customs broker
- Pricing and payment terms under current rules
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 ANMAT's questions during review
Made for Argentine 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 shown as Argentine rules require, the registration number, batch number, expiry date and storage conditions, and an approved proof before printing.
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Stability for your zone
Stability studies at the climate zone ANMAT 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 Argentina requires for tracking each medicine through the supply chain, applied to match its system.
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Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities insurers, provinces and hospitals buy.
Shipping to Argentina
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
Argentina's main port, with road freight across the country
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Rosario and the rivers
River ports on the Paraná for the interior
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Buenos Aires
By air to Ezeiza 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 Argentine distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Insurers and public programmes
The national retirees' insurance programme, provincial health systems and social health insurance funds buy generics in large volumes.
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Pharmacy chains
Large pharmacy chains and independent pharmacies sell branded and generic products.
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Hospitals
Public and private hospitals buy in hospital packs, often through tenders.
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Distributors
Licensed distributors supply pharmacies and clinics across the country.
Questions about supplying Argentina
Something else? Email [email protected].
Do you export medicines to Argentina?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Argentina.
Can you help us register products with ANMAT?
Yes. Progene Pharma prepares the documents ANMAT registration needs: a CTD dossier with stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Argentine company submits the application, and we answer ANMAT's questions with you.
Do I need a local company to register and import?
Yes. ANMAT registers a medicine to a company established in Argentina that holds the right authorisations. Check the current requirements with ANMAT.
How long does ANMAT 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 ANMAT's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does ANMAT ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. ANMAT updates its requirements from time to time, so confirm the current list with ANMAT or your regulatory agent. We tell you what we can provide with your quotation.
Does ANMAT inspect foreign manufacturing sites?
ANMAT checks that a manufacturing site complies with GMP and may inspect it, which can take time. We supply the certificates and site documents, and your team confirms the process with ANMAT.
How do import rules and payments work in Argentina?
Import licensing, currency rules and price controls change often, so we agree payment terms and timing with you before an order and tell you which documents your bank and customs need. Check the current rules with your customs broker.
Do doctors prescribe by generic name in Argentina?
Yes. National law requires prescribing by generic name, which favours generics. We design the artwork to show the generic name as the rules require, and you approve a proof before printing.
What must the packs carry for Argentina?
Spanish text, the generic name, the ANMAT registration number, batch number, manufacture and expiry dates, storage conditions and the other details ANMAT 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 Argentina?
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 Argentina?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Buenos Aires, or by air to Buenos Aires 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