Country · Latin America
Pharmaceutical exports to Colombia, ready for INVIMA registration
Progene Pharma supplies Colombian 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 INVIMA asks for, pack in Spanish, and ship to Cartagena and Buenaventura.
- Regulator
- INVIMA
- Labels
- Spanish
- Registration
- Sanitary registration, ten years
- Main ports
- Cartagena, Buenaventura
The Colombian medicines market in brief
Colombia is one of the larger pharmaceutical markets in Latin America, with a large population and a health system that covers almost everyone through health insurers and a benefits plan. It imports a large share of its medicines, alongside a local industry that is strong in generics.
Chronic care medicines for diabetes, high blood pressure and heart disease sell in large volumes, alongside antibiotics, pain medicines, gastric products and supplements. Medicine prices are regulated by the government, which pushes buyers toward quality generics at a controlled price.
The main buyers are the health insurers and the hospitals and pharmacies that supply them, together with pharmacy chains, distributors and public hospitals. A foreign manufacturer works through a company in Colombia that holds the registration.
Medicines we supply to Colombia
These are the medicines Colombian 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 Bogotá, Medellín, Cali and Barranquilla.
-
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.
INVIMA registration, step by step
A medicine cannot be imported or sold in Colombia until INVIMA 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 Colombia, usually the importer or distributor, acting for the manufacturer.
-
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. We prepare the manufacturer's documents.
-
04
INVIMA reviews it
INVIMA assesses the dossier and may ask questions, which we answer with you. Some generics also need bioequivalence data.
-
05
GMP evidence and samples
INVIMA checks that the manufacturing site complies with GMP, from the documents or an inspection, and may test samples.
-
06
Registration and renewal
On approval INVIMA issues a sanitary registration, valid for ten years and renewed before it expires. The registration number goes on every pack.
Registration takes from several months to more than a year, and INVIMA updates its requirements from time to time, so check the current guidelines with INVIMA or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Colombia
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The INVIMA application, as the registration holder
- The licences your business needs to import and distribute medicines
- Bioequivalence studies for generics where INVIMA asks for them
- The import permit and customs declaration, through your customs agent
- Pricing under the government's price controls
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 INVIMA's questions during review
Made for Colombian 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 sanitary registration number, batch number, expiry date and storage conditions INVIMA requires.
-
Stability for your zone
Stability studies at the climate zone INVIMA requires, with moisture-resistant blisters or bottles, so the shelf life on the pack is valid in warm, humid conditions.
-
Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities insurers, hospitals and chains 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 Colombia
Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your clearing agent needs.
-
Cartagena
The main Caribbean port, with road freight to Bogotá and Medellín
-
Buenaventura
The main Pacific port, for Cali and the west
-
Bogotá
By air to El Dorado 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 permit and customs declaration from your side
Where Colombian distributors sell
The same registered product moves through several channels, and each needs its own pack.
-
Insurers and hospitals
Health insurers and the hospitals and pharmacies that serve them buy generics in large volumes, within the price controls.
-
Pharmacy chains
Large pharmacy chains want branded packs of everyday generics and supplements.
-
Public hospitals
Public hospitals buy through tenders and ask for the full document set.
-
Distributors
Licensed distributors in Bogotá, Medellín and Cali supply independent pharmacies and clinics.
Questions about supplying Colombia
Something else? Email [email protected].
Do you export medicines to Colombia?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Colombia.
Can you help us register products with INVIMA?
Yes. Progene Pharma prepares the documents INVIMA registration needs: a CTD dossier with stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Colombian company submits the application, and we answer INVIMA's questions with you.
Do I need a local company to register and import?
Yes. INVIMA grants a sanitary registration to a company established in Colombia, usually the importer or distributor. Check the current requirements with INVIMA.
How long does INVIMA 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 INVIMA's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does INVIMA ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. INVIMA updates its requirements from time to time, so confirm the current list with INVIMA or your regulatory agent. We tell you what we can provide with your quotation.
Does INVIMA inspect foreign manufacturing sites?
INVIMA can check that a manufacturing site complies with GMP, from the documents or an inspection. We supply the certificates and site documents, and your team confirms the process with INVIMA.
Are medicine prices controlled in Colombia?
Yes. The government regulates the prices of many medicines, which affects what your distributor can charge, so agree your margins with the price controls in mind.
Can you supply public hospital tenders?
Yes. Progene Pharma supplies tender packs and the product documents tenders usually ask for. Tell us the tender requirements and we will confirm what we can provide.
What must the packs carry for Colombia?
Spanish text, the INVIMA sanitary registration number, batch number, manufacture and expiry dates, storage conditions and the other details INVIMA 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 Colombia?
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 Colombia?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Cartagena or Buenaventura, or by air to Bogotá 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