Country · Latin America
Pharmaceutical exports to Bolivia, ready for AGEMED registration
Progene Pharma supplies Bolivian 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 Medicines and Health Technologies asks for, pack in Spanish, and ship through Pacific ports for the road inland.
- Regulator
- AGEMED
- Labels
- Spanish
- Stability
- Climate zone set by the authority
- Main ports
- Arica, Iquique, Matarani
The Bolivian medicines market in brief
Bolivia is a landlocked Andean country. Its medicines arrive by sea at Pacific ports in Chile or Peru, or through Atlantic routes via Argentina and Brazil, and then travel inland by road, so lead times, transit paperwork and a capable customs agent matter.
Chronic care medicines for diabetes, high blood pressure and heart disease sell alongside antibiotics, pain medicines, gastric products, antiparasitics and supplements. Public health facilities and the social security funds buy through national tenders, while pharmacies and private clinics in La Paz, Santa Cruz and Cochabamba buy through importers.
AGEMED registers medicines and requires evidence of GMP compliance. Importers hold the registrations and supply pharmacies and hospitals, and high altitude in the highlands makes careful storage and packaging important.
Medicines we supply to Bolivia
These are the medicines Bolivian 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 La Paz, Santa Cruz and Cochabamba.
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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.
AGEMED registration, step by step
A medicine cannot be imported or sold in Bolivia until Agency for Medicines and Health Technologies (AGEMED) 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 Bolivia that holds the right licences, usually the importer or distributor, acting for the manufacturer. It applies to AGEMED.
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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
AGEMED reviews it
AGEMED 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
AGEMED 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 AGEMED 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 AGEMED updates its requirements from time to time, so check the current guidelines with AGEMED or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Bolivia
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The AGEMED application, as the registration holder
- The licences your business needs to import and distribute medicines
- Bioequivalence studies for generics, where AGEMED 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 AGEMED's questions during review
Made for Bolivian 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 AGEMED requires, and an approved proof before printing.
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Stability for your zone
Stability studies at the climate zone AGEMED 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 public 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 Bolivia
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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Arica and Iquique
Chilean Pacific ports, with road freight across the Andes to La Paz
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Matarani
A Peruvian port, an alternative route to the highlands
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Santa Cruz
By road, or by air to Viru Viru 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 documents and customs declaration from your side
Where Bolivian distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public health supply
Public hospitals and the social security funds buy through national tenders and ask 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 La Paz and Santa Cruz supply pharmacies and hospitals across the country.
Questions about supplying Bolivia
Something else? Email [email protected].
Do you export medicines to Bolivia?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Bolivia.
Can you help us register products with AGEMED?
Yes. Progene Pharma prepares the documents AGEMED registration needs: a CTD dossier with stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Bolivian company submits the application, and we answer AGEMED's questions with you.
Do I need a local company to register and import?
Yes. AGEMED grants a sanitary registration to a company established in Bolivia that holds the right licences, usually the importer or distributor. Check the current requirements with AGEMED.
How long does AGEMED 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 AGEMED's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does AGEMED ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. AGEMED updates its requirements from time to time, so confirm the current list with AGEMED or your regulatory agent. We tell you what we can provide with your quotation.
How do medicines reach Bolivia?
Bolivia is landlocked, so shipments go by sea to ports in Chile or Peru, or through routes via Argentina and Brazil, and then by road under a transit procedure. Your customs agent handles transit, and we confirm the schedule with your quotation.
Do generics need bioequivalence studies?
For some generics, yes, depending on the product and AGEMED's current requirements. Tell us the product and we will confirm what is needed before you apply.
Can you supply Bolivian 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 Bolivia?
Spanish text, the AGEMED sanitary registration number, batch number, manufacture and expiry dates, storage conditions and the other details AGEMED 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 Bolivia?
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 Bolivia?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Arica or Iquique in Chile, or Matarani in Peru, with onward road freight to La Paz and Santa Cruz, or by air to Santa Cruz 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
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- [email protected]
- Phone
- +91 22 49793146
- +91 90829 70494