Country · Latin America
Pharmaceutical exports to Ecuador, ready for ARCSA registration
Progene Pharma supplies Ecuadorian 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 Agency for Health Regulation and Surveillance asks for, pack in Spanish, and ship to Guayaquil.
- Regulator
- ARCSA
- Labels
- Spanish
- Stability
- Zone IVb, 30 °C / 75% RH
- Main port
- Guayaquil
The Ecuadorian medicines market in brief
Ecuador is a mid-sized Andean market with a dollarised economy, which keeps prices stable and payment simple. It imports a large share of its medicines, and generics are widely prescribed and sold, so competition on price and quality is strong.
Chronic care medicines for diabetes, high blood pressure and heart disease sell in large volumes, alongside antibiotics, pain medicines, gastric products and supplements. The public health system buys through national tenders, and a private sector of pharmacy chains, clinics and distributors buys alongside it.
ARCSA issues a sanitary registration for each medicine and requires evidence of GMP compliance for the manufacturing site. Importers in Guayaquil and Quito hold the registrations and supply pharmacies and hospitals.
Medicines we supply to Ecuador
These are the medicines Ecuadorian 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 Guayaquil, Quito and Cuenca.
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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.
ARCSA registration, step by step
A medicine cannot be imported or sold in Ecuador until the Agency for Health Regulation and Surveillance (ARCSA) 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 Ecuador that holds the right licences, usually the importer or distributor, acting for the manufacturer. It applies to ARCSA.
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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
ARCSA reviews it
ARCSA 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
ARCSA 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 ARCSA 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 ARCSA updates its requirements from time to time, so check the current guidelines with ARCSA or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Ecuador
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The ARCSA application, as the registration holder
- The licences your business needs to import and distribute medicines
- Bioequivalence studies for generics, where ARCSA 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 ARCSA's questions during review
Made for Ecuadorian 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 ARCSA requires, and an approved proof before printing.
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Stability for your zone
Stability studies at the climate zone ARCSA 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 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 Ecuador
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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Guayaquil
Ecuador's main seaport, with road freight to Quito and the highlands
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Quito
By road from Guayaquil, or by air to Mariscal Sucre International Airport for urgent orders and samples
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Within Ecuador
Onward road freight to Cuenca and the regions
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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 Ecuadorian distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public health supply
The national public system buys through tenders and asks 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 Guayaquil and Quito supply pharmacies and hospitals across the country.
Questions about supplying Ecuador
Something else? Email [email protected].
Do you export medicines to Ecuador?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Ecuador.
Can you help us register products with ARCSA?
Yes. Progene Pharma prepares the documents ARCSA registration needs: a CTD dossier with stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Ecuadorian company submits the application, and we answer ARCSA's questions with you.
Do I need a local company to register and import?
Yes. ARCSA grants a sanitary registration to a company established in Ecuador that holds the right licences, usually the importer or distributor. Check the current requirements with ARCSA.
How long does ARCSA 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 ARCSA's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does ARCSA ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. ARCSA updates its requirements from time to time, so confirm the current list with ARCSA or your regulatory agent. We tell you what we can provide with your quotation.
Does Ecuador use the US dollar?
Yes. Ecuador's economy is dollarised, which keeps prices stable and makes payment straightforward, and we quote in US dollars as usual.
Do generics need bioequivalence studies in Ecuador?
For some generics, yes, depending on the product and ARCSA's current lists. Tell us the product and we will confirm what is needed before you apply.
Can you supply Ecuadorian 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 Ecuador?
Spanish text, the ARCSA sanitary registration number, batch number, manufacture and expiry dates, storage conditions and the other details ARCSA 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 Ecuador?
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 Ecuador?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Guayaquil, or by air to Quito 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