Country · Latin America
Pharmaceutical exports to Chile, ready for ISP registration
Progene Pharma supplies Chilean 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 Institute of Public Health asks for, pack in Spanish, and ship to Valparaíso and San Antonio.
- Regulator
- Institute of Public Health
- Labels
- Spanish
- Registration
- Sanitary registration, five years
- Main ports
- Valparaíso, San Antonio
The Chilean medicines market in brief
Chile is a small, stable and open pharmaceutical market with high incomes by regional standards and a well-developed generics system. It imports a large share of its medicines, and bioequivalent generics carry a mark that doctors, pharmacists and patients recognise, which shapes how generics compete.
Chronic care medicines for diabetes, high blood pressure and heart disease sell in large volumes, alongside antibiotics, pain medicines, gastric products and supplements. Retail is concentrated in a few large pharmacy chains, which buy in large volumes and sell their own-label generics.
The public health system buys much of its medicine through the national central purchasing agency, CENABAST, which runs large tenders, while the pharmacy chains, private hospitals and distributors buy alongside it. The ISP requires bioequivalence data for the generics on its published list.
Medicines we supply to Chile
These are the medicines Chilean 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 Santiago, Valparaíso and Concepción.
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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.
ISP registration, step by step
A medicine cannot be imported or sold in Chile until the Institute of Public Health (ISP) 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 Chile that holds the right licences, 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 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
ISP reviews it
The ISP assesses the dossier and may ask questions, which we answer with you. A generic on the ISP's list also needs bioequivalence data.
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05
GMP evidence and samples
The ISP 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 the ISP issues a sanitary registration, valid for five years and renewed before it expires. The registration number goes on every pack.
Registration takes from several months to more than a year, and ISP updates its requirements from time to time, so check the current guidelines with ISP or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Chile
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The ISP application, as the registration holder
- The licences your business needs to import and distribute medicines
- Bioequivalence studies for the generics on the ISP's list
- 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 ISP's questions during review
Made for Chilean 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 the ISP requires, and the bioequivalence mark where it applies.
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Stability for your zone
Stability studies at the climate zone the ISP 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 the chains, CENABAST 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 Chile
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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Valparaíso and San Antonio
Chile's main Pacific ports, about an hour or two from Santiago by road
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Santiago
By road from the ports, or by air to Arturo Merino Benítez International Airport for urgent orders and samples
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Within Chile
Onward road freight to Concepción 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 Chilean distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public health supply
CENABAST runs large national tenders for the public health system, and asks for the full document set.
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Pharmacy chains
A few large pharmacy chains dominate retail, buy in large volumes, and sell 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
Licensed distributors supply independent pharmacies and clinics across the country.
Questions about supplying Chile
Something else? Email [email protected].
Do you export medicines to Chile?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Chile.
Can you help us register products with ISP?
Yes. Progene Pharma prepares the documents ISP registration needs: a CTD dossier with stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Chilean company submits the application, and we answer ISP's questions with you.
Do I need a local company to register and import?
Yes. The ISP grants a sanitary registration to a company established in Chile that holds the right licences, usually the importer or distributor. Check the current requirements with the ISP.
How long does ISP 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 ISP's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does ISP ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. ISP updates its requirements from time to time, so confirm the current list with ISP or your regulatory agent. We tell you what we can provide with your quotation.
Do generics need bioequivalence studies in Chile?
For the generics on the ISP's published list, yes, and bioequivalent products carry a recognised mark on the pack. Tell us the product and we will confirm what is needed before you apply.
Can you supply CENABAST tenders?
Yes. Progene Pharma supplies tender packs and the product documents public tenders usually ask for. Tell us the tender requirements and we will confirm what we can provide.
Who buys generics in Chile?
Mainly the large pharmacy chains, which sell own-label generics, together with the public system through CENABAST, private hospitals and distributors. We supply the documents and packs each channel needs.
What must the packs carry for Chile?
Spanish text, the generic name, the ISP sanitary registration number, batch number, manufacture and expiry dates, storage conditions and the other details the ISP 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 Chile?
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 Chile?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Valparaíso or San Antonio, or by air to Santiago 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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- [email protected]
- Phone
- +91 22 49793146
- +91 90829 70494