Country · Latin America
Pharmaceutical exports to Peru, ready for DIGEMID registration
Progene Pharma supplies Peruvian 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 DIGEMID asks for, label in Spanish, and ship to Callao.
- Regulator
- DIGEMID
- Labels
- Spanish
- Registration
- Sanitary registration, five years
- Main port
- Callao
The Peruvian medicines market in brief
Peru is a mid-sized pharmaceutical market with a population of more than thirty million, a growing middle class and a mix of public and private supply. It imports most of its medicines, and generics account for a large share of pharmacy sales.
Antibiotics, pain medicines, gastric products and supplements sell in large volumes, and diabetes, high blood pressure and heart disease are growing quickly. Public health facilities and the social security system buy large quantities, and large pharmacy chains dominate retail in Lima.
The Ministry of Health's national supply agency, CENARES, buys for public facilities through large national purchases, and the social security system, EsSalud, runs its own tenders, while private hospitals, pharmacy chains and distributors buy alongside them.
Medicines we supply to Peru
These are the medicines Peruvian 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 Lima, Arequipa and Trujillo.
-
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.
DIGEMID registration, step by step
A medicine cannot be imported or sold in Peru until DIGEMID, the national medicines directorate, 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 Peru that holds the right licences, 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
DIGEMID reviews it
DIGEMID assesses the dossier and may ask questions, which we answer with you. Some generics also need bioequivalence data.
-
05
GMP evidence and samples
DIGEMID checks that the manufacturing site complies with GMP, from the documents or an inspection, and may test samples.
-
06
Registration and renewal
On approval DIGEMID 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 DIGEMID updates its requirements from time to time, so check the current guidelines with DIGEMID or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Peru
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The DIGEMID application, as the registration holder
- The licences your business needs to import and distribute medicines
- Bioequivalence studies, where DIGEMID asks for them
- The import documents and customs declaration, through your customs agent
- Payment, and clearance at Callao
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 DIGEMID's questions during review
Made for Peruvian 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 DIGEMID requires, and an approved proof before printing.
-
Stability for your zone
Stability studies at the climate zone DIGEMID 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 the national supply agency, the social security system 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 Peru
Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your clearing agent needs.
-
Callao
Peru's main port, beside Lima, the usual route for goods from Asia
-
Lima
By road from Callao, or by air to Jorge Chávez International Airport for urgent orders and samples
-
Within Peru
Onward road freight to Arequipa, Trujillo and the regions
-
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 Peruvian distributors sell
The same registered product moves through several channels, and each needs its own pack.
-
Public health supply
CENARES and the regional health authorities buy for public facilities through large national purchases and tenders, and ask for the full document set.
-
Social security
EsSalud runs its own tenders for its hospitals and clinics.
-
Pharmacy chains
Large pharmacy chains in Lima and the regions sell branded and own-label generics.
-
Distributors
Licensed distributors supply independent pharmacies and clinics across the country.
Questions about supplying Peru
Something else? Email [email protected].
Do you export medicines to Peru?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Peru.
Can you help us register products with DIGEMID?
Yes. Progene Pharma prepares the documents DIGEMID registration needs: a CTD dossier with stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Peruvian company submits the application, and we answer DIGEMID's questions with you.
Do I need a local company to register and import?
Yes. DIGEMID grants a sanitary registration to a company established in Peru that holds the right licences, usually the importer or distributor. Check the current requirements with DIGEMID.
How long does DIGEMID 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 DIGEMID's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does DIGEMID ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. DIGEMID updates its requirements from time to time, so confirm the current list with DIGEMID or your regulatory agent. We tell you what we can provide with your quotation.
Does DIGEMID require bioequivalence studies?
For some products, yes. DIGEMID publishes a list of products that need bioequivalence data. Tell us the product and we will confirm what is needed before you apply.
Can you supply CENARES and EsSalud 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.
How do medicines reach Peru?
Shipments go by sea to Callao, the main port beside Lima, and then by road to the rest of the country. Your customs agent handles clearance, and we confirm the schedule with your quotation.
What must the packs carry for Peru?
Spanish text, the DIGEMID sanitary registration number, batch number, manufacture and expiry dates, storage conditions and the other details DIGEMID 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 Peru?
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 Peru?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Callao, or by air to Lima 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