Country · North America
Pharmaceutical and health product exports to Canada
Progene Pharma supplies Canadian importers, brand owners and distributors with products we manufacture in a WHO-GMP certified facility: natural health products, herbal and personal care products, over-the-counter medicines and generic medicines for partners who hold the approval. We prepare the manufacturer's documents for your Health Canada filings and confirm, before we quote, which route the product follows.
- Regulator
- Health Canada
- Labels
- English and French
- Importer licence
- Drug Establishment Licence, for drugs
- Main ports
- Vancouver, Montreal, Halifax
The Canadian market in brief
Canada has a mature, well-regulated health market with a high use of generic medicines, a strong natural health product sector and publicly funded provincial drug plans alongside a large private market. Supply runs through wholesalers, pharmacy chains and, for natural health products, health stores and online sellers.
Health Canada regulates by product type. Drugs, natural health products and cosmetics follow different rules, and a medicine, supplement or personal care product each needs the right licence, product approval or notification before it is sold.
Canada also has two official languages, so cartons and leaflets for the market are normally written in English and French, which affects artwork and lead times.
Medicines we supply to Canada
These are the categories Canadian importers ask us about. Whether a product can be sold depends on its category and on your company's licences, so we confirm that before we quote. See all human formulations
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Natural health products
Vitamins, minerals, herbal products and probiotics for brands that sell through pharmacies, health stores and online.
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Herbal and Ayurvedic products
Ashwagandha, turmeric and triphala products, made to your formula and label.
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Personal care and cosmetics
Face washes, moisturisers, shampoos and soaps under your brand, with bilingual ingredient lists.
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Over-the-counter medicines
Paracetamol, ibuprofen and antacid products for brands that sell over the counter, where the product meets the requirements for its category.
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Generics for approved partners
Tablets, capsules and injectables for companies that hold the approval, with the manufacturer's data they need.
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Veterinary products
Oral liquids and other animal health products for importers who handle the separate veterinary approvals.
How the Health Canada route works, by product type
There is no single registration for Canada. The steps depend on the product category, and the Canadian importer or licence holder carries most of the filings. This is the usual outline.
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01
Decide the category
A drug, a natural health product and a cosmetic follow different rules, so the category fixes everything that comes after.
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02
A Canadian company holds the licences
A company established in Canada, usually the importer or distributor, holds the licence for the activity, such as a Drug Establishment Licence to import drugs, or a site licence for natural health products.
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03
Show the foreign site meets GMP
Health Canada expects evidence that the foreign manufacturing site complies with GMP. We provide the certificates, batch records and testing data that show how the product is made and tested.
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04
Get the product authorised
Drugs need a product authorisation and a Drug Identification Number, and generics file a submission using the manufacturer's data. Natural health products need a product licence and a Natural Product Number. Cosmetics are notified to Health Canada after first sale.
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05
Label in both languages
Labels follow the rules for the category and are normally written in English and French.
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06
Import and sell
Each shipment is cleared through the Canada Border Services Agency by your customs broker, against the licences your company holds.
Requirements and timelines change, so check the current rules with Health Canada or a Canadian regulatory consultant. We never promise an approval or a date.
Who does what when you import into Canada
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The establishment or site licence as the Canadian importer
- Product licences, authorisations and notifications
- Bilingual labels that meet Health Canada rules
- Customs clearance through a licensed broker
Progene Pharma handles
- Manufacture in a WHO-GMP certified facility
- GMP certificates, batch records and testing data
- A Certificate of Analysis for every batch, and stability data
- Safety data sheets and the manufacturing and testing information for your filing
- Artwork laid out to match your label
Made for Canadian 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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English and French labels
Cartons and leaflets in English and French, with the ingredient list, lot number, expiry date, storage conditions and the other details Health Canada requires for the category.
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Stability for your zone
Stability studies at long-term conditions of 25 °C and 60% relative humidity, the zone Canadian rules ask for, so the shelf life on the pack holds up.
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Records for inspection
Batch records, change control and testing data kept ready for the site evidence and audits that Canadian buyers and Health Canada ask for.
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Packs for every channel
Retail packs for pharmacies and online sale, and bulk or hospital packs, in the quantities your customers buy.
Shipping to Canada
Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your customs broker needs.
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Vancouver
The main Pacific port, for western Canada and for rail freight east
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Montreal
The main port for Quebec and central Canada, on the St. Lawrence
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Halifax
The Atlantic gateway for eastern Canada
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Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, and the customs declaration that your broker files
Where Canadian brands sell
The same product can move through several channels, and each has its own pack and its own buyer checks.
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Pharmacy chains
Large pharmacy chains buy generics and over-the-counter brands and run supplier qualification.
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Health stores and online
Natural health product brands sell through health stores and online sellers.
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Wholesalers and distributors
Licensed wholesalers supply pharmacies, clinics and hospitals across the provinces.
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Institutions
Hospitals and provincial programmes buy through group purchasing and tenders.
Questions about supplying Canada
Something else? Email [email protected].
Do you export to Canada?
Yes. Progene Pharma manufactures in a WHO-GMP certified facility and supplies Canadian importers, brand owners and distributors. Which products we can supply depends on the product category and on the licences your company holds, and we confirm that before we quote.
Does Health Canada accept your GMP certificates?
Our facility is certified to WHO-GMP, EU-GMP and ISO standards, and we provide the certificates, batch records and testing data. Health Canada decides what evidence it accepts for each product, so check the current position with Health Canada or ask us what we can provide.
Do I need a Drug Establishment Licence?
A company that imports drugs into Canada normally needs a Drug Establishment Licence. Natural health products have their own site licensing. Your regulatory consultant or Health Canada can confirm what applies to you.
Can you make natural health products under my brand?
Yes. Progene Pharma makes vitamins, minerals, herbal products and probiotics under your brand and label. Your company holds the product licence and Natural Product Number that Health Canada requires.
Can you supply generic medicines for Canada?
Only to companies that hold, or are building, the approval. We provide the manufacturer's data and documents for that submission, and we do not sell unapproved medicines for Canada.
Do the labels need to be in French?
Labels for the Canadian market are normally written in English and French. We prepare the artwork in both languages to match your filing.
Which documents do you provide?
The usual set is a Certificate of Analysis for every batch, the GMP certificates, stability data, safety data sheets, and the manufacturing and testing information your licence or submission needs.
How are orders shipped to Canada?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Vancouver, Montreal or Halifax, or by air 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 as well as smaller brands, 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