Market
Pharmaceutical and health product exports to North America
Progene Pharma supplies importers, brand owners and distributors in the United States and Canada with products we manufacture in a WHO-GMP certified facility: nutraceuticals, herbal and personal care products, over-the-counter medicines and generic medicines for partners who hold the approval. We prepare the manufacturer's documents, and your company, as the importer and the holder, files them with the FDA or Health Canada.
- Regulators
- FDA and Health Canada
- Labels
- English; English and French for Canada
- Stability
- Climate Zone II, 25 °C / 60% RH
- Rules
- Set by product type: supplement, cosmetic, OTC or prescription
Why North American importers source from India
India is one of the largest suppliers of generic medicines and health products to the United States and Canada. Indian manufacturers make the same molecules as the original brands, to the same pharmacopoeia standards, at a lower cost. We manufacture in a WHO-GMP certified facility that is FDA approved and also holds EU-GMP and ISO certification, and we keep batch records and testing data ready for the audits that North American buyers run.
Rules in North America depend on what the product is. A dietary supplement, a cosmetic, an over-the-counter medicine and a prescription generic each follow a different route in both countries, so we start every enquiry by working out which one applies. We then confirm what we can supply and what the importer and brand owner still need to do before shipping.
Medicines we supply to North America
These are the categories North American importers ask us about. Whether a given product can be sold depends on its category and on the importer's approvals, so we confirm that with you before we quote. See all human formulations
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Vitamins and supplements
Multivitamins, vitamin D3, omega-3, probiotics and protein products for brands selling through pharmacies, health stores and online.
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Herbal and Ayurvedic products
Ashwagandha, turmeric, triphala and other herbal products, made to your formula and label, with the quality records a buyer will ask for.
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Personal care and cosmetics
Face washes, moisturisers, shampoos and soaps under your brand, with ingredient lists laid out to North American labelling rules.
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Over-the-counter medicines
Paracetamol, ibuprofen and antacid products for brands that sell over the counter, subject to the product meeting the FDA or Health Canada requirements for its category.
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Generic medicines for approved partners
Tablets, capsules and injectables for companies that hold, or are building, an approved application, with the manufacturer's data they need to file it.
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Veterinary products
Oral liquids, boluses and other animal health products for importers who handle the separate veterinary approvals.
Medicine regulators in North America
Each country registers medicines through its own regulator. These are the authorities in the largest markets; we prepare dossiers in the formats they expect.
United States
- United States
- Food and Drug Administration (FDA)
Canada
- Canada
- Health Canada
Both countries regulate by product type. Supplements, cosmetics, over-the-counter medicines and prescription generics each have their own route, and foreign manufacturing sites are expected to meet GMP and, for medicines, to be registered or licensed through the importer. Rules change, so confirm the current requirements with the regulator or your regulatory consultant before you order.
How registration usually works
Timelines vary widely by category. Supplements and cosmetics need registrations and notifications rather than product approval, while generic medicines need an approved application, which takes much longer. We never promise an approval or a date.
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01
Decide the product category
Whether the product is a supplement, a cosmetic, an over-the-counter medicine or a prescription generic decides which approvals apply, so this comes first.
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02
Appoint the importer and the holder
In both countries a company established there, such as the importer or the brand owner, holds the approvals or listings and deals with the regulator. In the United States a foreign facility also needs a U.S. agent.
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03
Exchange the manufacturer's documents
We prepare the Certificate of Analysis, the GMP certificates, stability data, safety data sheets and the manufacturing and testing information your application or listing needs.
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04
File, list or license
Your company files the application, listing or notification with the FDA or Health Canada, and any facility registration, licence or inspection that the category requires is completed before the product is sold.
Made for North American 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 for the United States, and in English and French for Canada, laid out to the labelling rules of each country.
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Stability for your zone
Stability studies at long-term conditions of 25 °C and 60% relative humidity, the zone North America asks for, so the shelf life on the pack holds up.
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Quality records for audits
Batch records, testing data and change control kept ready for the audits and supplier qualification that North American buyers run.
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Packs for your channel
Retail packs for pharmacies and online sale, and bulk or hospital packs for institutions, in the quantities your customers buy.
Shipping to North America
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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U.S. East Coast
New York and New Jersey, Savannah and Norfolk, with road and rail freight inland
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U.S. West and Gulf Coast
Los Angeles, Long Beach and Houston
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Canada
Vancouver and Montreal, and Halifax, with onward road and rail freight
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Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, and the import filings that your customs broker makes
Questions about supplying North America
Something else? Email [email protected].
Do you export to the United States and Canada?
Yes. Progene Pharma manufactures in a WHO-GMP certified facility and supplies importers, brand owners and distributors in the United States and Canada. Which products we can supply depends on the product category and on the approvals your company holds, and we confirm that with you before we quote.
Is your facility approved by the FDA or Health Canada?
Our facility is FDA approved, and it is also certified to WHO-GMP, EU-GMP and ISO standards. Approval of the facility is separate from approval of a product, and Health Canada licensing is a separate step that depends on the product category. Ask us about the product you have in mind and we will tell you what is needed.
Can you supply prescription generics for the United States or Canada?
Only to companies that hold, or are building, an approved application, such as an ANDA in the United States or an abbreviated submission in Canada. We provide the manufacturer's data and documents for that application, and we do not sell unapproved prescription medicines for these markets.
Can you make dietary supplements and cosmetics under my brand?
Yes. Progene Pharma makes nutraceuticals, herbal products and personal care products under your brand and label. Supplements and cosmetics follow notification and facility rules rather than product approval, and your company handles the filings that the law places on the brand owner or importer.
Do I need a local company to import?
Yes. In both countries a company established there acts as the importer and holds the listings or licences. In the United States a foreign manufacturing facility also appoints a U.S. agent for the FDA.
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 application or listing needs. Tell us the product and the regulator, and we will confirm the set.
What must the labels carry?
English for the United States, and English and French for Canada, with the ingredient list, lot number, expiry date, storage conditions and the other details each regulator requires for the category. We prepare the artwork to match your filing.
How are orders shipped?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to U.S. and Canadian ports, 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.
Explore more
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