Country · North America
Pharmaceutical and health product exports to the United States
Progene Pharma supplies U.S. importers, brand owners and distributors 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 an FDA approval. We prepare the manufacturer's documents and tell you, before we quote, which route the product follows and what your company still has to file.
- Regulator
- FDA
- Labels
- English
- Prescription generics
- Approved ANDA required
- Main ports
- New York and New Jersey, Los Angeles
The U.S. market in brief
The United States is the largest health market in the world, with a very large generics sector, a big supplement and wellness market, and strong online sale. Most prescriptions filled in the country are for generic medicines, and the supply chain runs through wholesalers, pharmacy chains, pharmacy benefit managers and online sellers.
Because the market is regulated by product type, the first question is always what the product is. Dietary supplements, cosmetics, over-the-counter drugs and prescription generics sit under different parts of the law and need different filings, so a plan that works for a supplement does not carry over to a prescription tablet.
Buyers audit their suppliers closely and ask for batch records, change control and stability data. Brands that sell supplements, herbal products and personal care products through pharmacies and online channels are the usual starting point for a new manufacturer.
Medicines we supply to the United States
These are the categories U.S. importers ask us about. Whether a product can be sold depends on its category and on your company's approvals, so we confirm that 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 that sell online and through pharmacies and health stores.
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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 the ingredient list and labelling U.S. rules require.
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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 an approved ANDA, 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 FDA route works, by product type
There is no single registration for the United States. The steps depend on the product category, and the importer or brand owner, not the manufacturer, carries most of the filings. This is the usual outline.
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01
Decide the category
A dietary supplement, a cosmetic, an over-the-counter drug and a prescription generic follow different parts of the law, so the category fixes everything that comes after.
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02
Register the facility and appoint a U.S. agent
Foreign facilities that make drugs, supplements or cosmetics for the U.S. market register with the FDA, and a foreign facility names a U.S. agent who handles communication with the agency.
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03
Meet the cGMP rules for the category
Drugs, dietary supplements and cosmetics each have their own manufacturing quality rules. We provide the batch records, testing data and certificates that show how the product is made and tested, and the FDA may inspect a facility.
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04
List the products
Drug products are listed with the FDA, cosmetic products and facilities are registered and listed, and supplements follow their own notification and labelling rules. Your company, as the brand owner or importer, makes the listing.
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05
File an application for prescription generics
A prescription generic can be sold only under an approved ANDA. The applicant files it with the FDA, using the manufacturer's data on the product, its manufacture and its stability.
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06
Import and sell
Each shipment is entered through customs, and the FDA reviews it at the border. Labels follow the rules for the category.
Requirements and fees change, and an FDA inspection of the manufacturing facility can be part of the process, so check the current rules with the FDA or a U.S. regulatory consultant. We never promise an approval, an inspection outcome or a date.
Who does what when you import into the United States
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- Product listings and notifications as the brand owner or importer
- The ANDA, if you market a prescription generic
- The U.S. agent, where the facility needs one
- Labelling that meets FDA rules for the category
- Customs entry through a licensed broker
Progene Pharma handles
- Manufacture in a WHO-GMP certified facility
- Batch records, testing data and a Certificate of Analysis for every batch
- GMP certificates and stability data at the zone U.S. rules ask for
- Safety data sheets and the manufacturing and testing information for your filing
- Artwork laid out to match your label
Made for 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 labels
Cartons and leaflets in English, with the ingredient list, lot number, expiry date, storage conditions and the other details the rules for the category require.
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Stability for your zone
Stability studies at long-term conditions of 25 °C and 60% relative humidity, the zone U.S. rules ask for, so the shelf life on the pack holds up.
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Records for audits
Batch records, change control and testing data kept ready for the supplier audits that U.S. buyers run.
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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 the United States
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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New York and New Jersey
The main East Coast gateway, with road and rail freight inland
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Savannah and Norfolk
East Coast ports for the Southeast and the Mid-Atlantic
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Los Angeles and Long Beach
The main West Coast gateway
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Houston
The main Gulf Coast port
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Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, and the customs entry and FDA prior notice that your broker files
Where U.S. 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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Online sellers
Marketplaces and direct-to-consumer brands sell supplements and personal care products, and ask for clear labelling and quality records.
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Pharmacy chains and retailers
Large chains and retailers run supplier qualification and audits before they list a product.
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Wholesalers and distributors
Licensed wholesalers supply pharmacies, clinics and institutions across the country.
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Health and specialty stores
Independent health stores and specialty retailers sell herbal and Ayurvedic products.
Questions about supplying the United States
Something else? Email [email protected].
Do you export to the United States?
Yes. Progene Pharma manufactures in a WHO-GMP certified facility and supplies U.S. importers, brand owners and distributors. Which products we can supply depends on the product category and on the approvals your company holds, and we confirm that before we quote.
Is your facility FDA approved?
Yes. 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: prescription generics still need an approved ANDA, and supplements, cosmetics and over-the-counter products follow the rules for their category. Ask us about your product and we will tell you what is needed.
Can you supply prescription generics for the U.S. market?
Only to companies that hold, or are building, an approved ANDA. We provide the manufacturer's data and documents for that application, and we do not sell unapproved prescription medicines for the United States.
Can you make dietary supplements under my brand?
Yes. Progene Pharma makes nutraceuticals and herbal products under your brand and label. Supplements follow FDA facility, labelling and notification rules rather than product approval, and your company handles the filings the law places on the brand owner.
Can you make cosmetics and personal care products?
Yes. We make face washes, moisturisers, shampoos and soaps under your brand. Cosmetics have their own facility and product listing rules in the United States, and the responsible person for the product, usually your company, makes the listing.
Do I need a U.S. agent?
A foreign facility that makes products for the U.S. market names a U.S. agent for the FDA. Tell us what you need and we will explain how this works with your importer.
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 listing or application needs.
How are orders shipped to the United States?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to New York and New Jersey, Los Angeles, Savannah or Houston, 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