Country · Latin America
Pharmaceutical exports to Mexico, ready for COFEPRIS registration
Progene Pharma supplies Mexican 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 federal health authority asks for, pack in Spanish, and ship to Manzanillo and Veracruz.
- Regulator
- COFEPRIS
- Labels
- Spanish
- Registration
- Sanitary registration, five years
- Main ports
- Manzanillo, Veracruz
The Mexican medicines market in brief
Mexico has the second largest pharmaceutical market in Latin America, with a large population, a big generics market and a mix of public and private supply. It also has a strong local manufacturing base, so imported generics compete on quality, price and documentation.
Diabetes, high blood pressure and obesity-related conditions are among the country's leading health challenges, so chronic care medicines sell in very large volumes. Antibiotics, pain medicines, gastric products and supplements are staples of pharmacy sales, and the large pharmacy chains also sell their own branded generics.
The public sector buys for its health institutes through large national purchases, while private hospital groups, pharmacy chains and distributors buy alongside it. Generics sold as interchangeable with the reference product must show bioequivalence, which shapes registration.
Medicines we supply to Mexico
These are the medicines Mexican 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 Mexico City, Guadalajara and Monterrey.
-
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.
COFEPRIS registration, step by step
A medicine cannot be imported or sold in Mexico until the federal health authority, COFEPRIS, 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 Mexico that has the right sanitary licence, 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 in the Mexican format 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
COFEPRIS reviews it
COFEPRIS assesses the dossier and may ask questions, which we answer with you. A generic sold as interchangeable also needs bioequivalence data from an authorised laboratory.
-
05
GMP evidence and samples
COFEPRIS checks that the manufacturing site complies with GMP, from the documents or an inspection, and may test samples.
-
06
Registration and renewal
On approval COFEPRIS 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 COFEPRIS updates its requirements from time to time, so check the current guidelines with COFEPRIS or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Mexico
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The COFEPRIS application, as the registration holder
- The sanitary licences your business needs to import and distribute medicines
- Bioequivalence studies for interchangeable generics
- The sanitary import permit for each shipment, and the customs declaration through a licensed customs broker
- 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 COFEPRIS's questions during review
Made for Mexican 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, laid out to the Mexican official standards, with the sanitary registration number, batch number, expiry date and storage conditions, and the generic mark where it applies.
-
Stability for your zone
Stability studies at the climate zone Mexican rules require, 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 the public institutes, pharmacy chains and distributors 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 Mexico
Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your clearing agent needs.
-
Manzanillo
The main Pacific port, the usual route for goods from Asia, with road and rail freight to Mexico City and Guadalajara
-
Veracruz
The main Gulf port, for the east and the centre
-
Mexico City
By air to Mexico City 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 sanitary import permit and customs declaration from your side
Where Mexican distributors sell
The same registered product moves through several channels, and each needs its own pack.
-
Public health institutes
The large public health institutes buy through national purchases and ask for the full document set.
-
Pharmacy chains
Large pharmacy chains sell branded and own-label generics, and want consistent quality and supply.
-
Private hospital groups
Private hospital groups buy in hospital packs, often through group contracts.
-
Distributors
Licensed distributors supply independent pharmacies and clinics across the country.
Questions about supplying Mexico
Something else? Email [email protected].
Do you export medicines to Mexico?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Mexico.
Can you help us register products with COFEPRIS?
Yes. Progene Pharma prepares the documents COFEPRIS registration needs: a CTD dossier with stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Mexican company submits the application, and we answer COFEPRIS's questions with you.
Do I need a local company to register and import?
Yes. COFEPRIS grants a sanitary registration to a company established in Mexico that holds the right licences, and a licensed customs broker handles each import. Check the current requirements with COFEPRIS.
How long does COFEPRIS 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 COFEPRIS's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does COFEPRIS ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. COFEPRIS updates its requirements from time to time, so confirm the current list with COFEPRIS or your regulatory agent. We tell you what we can provide with your quotation.
Do generics need bioequivalence studies in Mexico?
A generic sold as interchangeable with the reference product must show bioequivalence at an authorised laboratory. Tell us the product and we will confirm what is needed before you apply.
Do I need a customs broker?
Yes. Mexican law requires a licensed customs broker to handle imports. Your company appoints the broker, and the shipping documents we send support the declaration.
Can you supply public tenders?
Yes. Progene Pharma supplies tender packs and the product documents public purchases usually ask for. Tell us the tender requirements and we will confirm what we can provide.
What must the packs carry for Mexico?
Spanish text, the sanitary registration number, batch number, manufacture and expiry dates, storage conditions and the other details Mexican standards require. 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 Mexico?
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 Mexico?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Manzanillo or Veracruz, or by air to Mexico 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