Country · Latin America
Pharmaceutical exports to Guatemala, ready for ministry registration
Progene Pharma supplies Guatemalan 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 Ministry of Public Health and Social Assistance asks for, pack in Spanish, and ship to Puerto Quetzal and Santo Tomás de Castilla.
- Regulator
- Ministry of Public Health
- Labels
- Spanish
- Stability
- Climate zone set by the authority
- Main ports
- Puerto Quetzal, Santo Tomás de Castilla
The Guatemalan medicines market in brief
Guatemala is the largest economy in Central America, with a young population and a large rural share. It imports a large share of its medicines, and generics are widely sold, so competition on price and quality is strong.
Chronic care medicines for diabetes, high blood pressure and heart disease sell alongside antibiotics, pain medicines, gastric products, antiparasitics and supplements. The Ministry of Health and the social security institute buy for public hospitals through tenders, while pharmacy chains, private clinics and distributors buy alongside them.
The Ministry of Public Health and Social Assistance registers medicines and requires evidence of GMP compliance. Importers in Guatemala City hold the registrations and some also supply neighbouring Central American markets.
Medicines we supply to Guatemala
These are the medicines Guatemalan distributors ask us for most. We make any human formulation to your specification, under your brand. See all human formulations
-
Generic medicines for pharmacies
Analgesics, antihistamines, gastric medicines and everyday prescription generics in the strengths and packs pharmacies sell.
-
Antibiotics and infections
Amoxicillin, amoxicillin and clavulanic acid, azithromycin, ciprofloxacin, cefixime and ceftriaxone injection, for clinics and hospitals.
-
Pain and fever
Paracetamol, ibuprofen and diclofenac in tablets, suspensions and injections.
-
Diabetes and heart care
Metformin, glimepiride, amlodipine, losartan and atorvastatin, as long-term conditions become a larger share of prescriptions in Guatemala City, Quetzaltenango and Escuintla.
-
Stomach and allergy
Omeprazole, pantoprazole, cetirizine, montelukast and cough syrups, for everyday pharmacy sale.
-
Hospital and tender supplies
IV fluids, injectable antibiotics, anaesthetics and analgesics in hospital packs for tenders.
-
Vitamins and supplements
Multivitamins, vitamin D3, omega-3, probiotics and protein products for pharmacies, health stores and online sellers.
-
Herbal and personal care
Herbal products, creams, washes, shampoos and soaps under your brand, with the ingredient lists your authority requires.
MSPAS registration, step by step
A medicine cannot be imported or sold in Guatemala until Ministry of Public Health and Social Assistance has granted a sanitary registration. This is the usual route for a finished pharmaceutical product made abroad.
-
01
A local company applies
The registration is held by a company established in Guatemala that holds the right licences, usually the importer or distributor, acting for the manufacturer. It applies to MSPAS.
-
02
The manufacturer authorises it
The manufacturer gives the applicant a letter of authorisation that names the product and the company, which we provide.
-
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.
-
04
MSPAS reviews it
MSPAS assesses the dossier and may ask questions, which we answer with you. A generic may need bioequivalence data.
-
05
GMP evidence and samples
MSPAS checks that the manufacturing site complies with GMP, from the documents or an inspection, and may test samples.
-
06
Registration and renewal
On approval MSPAS 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 MSPAS updates its requirements from time to time, so check the current guidelines with MSPAS or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Guatemala
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The MSPAS application, as the registration holder
- The licences your business needs to import and distribute medicines
- Bioequivalence studies for generics, where MSPAS 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 MSPAS's questions during review
Made for Guatemalan conditions
Heat, humidity, long journeys and several languages: what a medicine needs to stay good from the port to the patient.
-
Labels in Spanish
Cartons and patient leaflets in Spanish, with the generic name, the sanitary registration number, batch number, expiry date and storage conditions MSPAS requires, and an approved proof before printing.
-
Stability for your zone
Stability studies at the climate zone MSPAS requires, with moisture-resistant blisters or bottles, so the shelf life on the pack is valid.
-
Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities pharmacies, distributors and public hospitals buy.
-
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 Guatemala
Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your clearing agent needs.
-
Puerto Quetzal
The main Pacific port, about 100 kilometres from Guatemala City by road
-
Santo Tomás de Castilla
The Atlantic port, with road freight to the capital
-
Guatemala City
By air to La Aurora International Airport for urgent orders and samples
-
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 Guatemalan distributors sell
The same registered product moves through several channels, and each needs its own pack.
-
Public health supply
The Ministry of Health and the social security institute buy for public hospitals through tenders and ask for the full document set.
-
Pharmacy chains
Pharmacy chains buy in volume and sell branded and own-label generics.
-
Private hospitals and clinics
Private hospital groups and clinics buy in hospital packs, often through group contracts.
-
Distributors
Distributors in Guatemala City supply pharmacies and hospitals across the country.
Questions about supplying Guatemala
Something else? Email [email protected].
Do you export medicines to Guatemala?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Guatemala.
Can you help us register products with MSPAS?
Yes. Progene Pharma prepares the documents MSPAS registration needs: a CTD dossier with stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Guatemalan company submits the application, and we answer MSPAS's questions with you.
Do I need a local company to register and import?
Yes. MSPAS grants a sanitary registration to a company established in Guatemala that holds the right licences, usually the importer or distributor. Check the current requirements with MSPAS.
How long does MSPAS 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 MSPAS's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does MSPAS ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. MSPAS updates its requirements from time to time, so confirm the current list with MSPAS or your regulatory agent. We tell you what we can provide with your quotation.
Do generics need bioequivalence studies?
For some generics, yes, depending on the product and the ministry's current requirements. Tell us the product and we will confirm what is needed before you apply.
Can a Guatemalan distributor supply other Central American countries?
Some do. Each country registers the medicine itself, although Central American countries work towards shared procedures. Tell us the countries you plan to sell in and we will confirm the documents each one needs.
Can you supply Guatemalan 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 Guatemala?
Spanish text, the MSPAS sanitary registration number, batch number, manufacture and expiry dates, storage conditions and the other details MSPAS 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 Guatemala?
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 Guatemala?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Puerto Quetzal or Santo Tomás de Castilla, or by air to Guatemala City 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