Market
Pharmaceutical exports to Europe, with EU-GMP certification behind them
Progene Pharma supplies importers, distributors and marketing authorisation holders across the European Union, the United Kingdom, Switzerland and the wider region with generic medicines we manufacture in an EU-GMP and WHO-GMP certified facility. Documented in the CTD format, tested to European stability conditions, and labelled in the language of each country.
- Markets
- EU, UK, Switzerland, Türkiye
- Certification
- EU-GMP, WHO-GMP, ISO
- Stability
- Zone II, 25 °C / 60% RH
- Dossiers
- CTD, European format
Why European importers choose Progene Pharma
Progene Pharma makes the same molecules as the original brands, to the same pharmacopoeia standards, at a fraction of the price. Our facility holds EU-GMP certification, the standard European authorities look for in a manufacturer outside the EU, as well as WHO-GMP and ISO.
We work with your company as the marketing authorisation holder or the importer, and prepare the manufacturing and quality documents it needs. Orders ship by sea from Nhava Sheva (JNPT), near Mumbai, to the main European ports, or by air when they are urgent.
Medicines we supply to Europe
These are the products European buyers ask us for most. We make any product to your specification, under your brand. See all human formulations
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Generic medicines
Tablets, capsules, syrups and injections in the generics that importers and marketing authorisation holders ask for, made to the European or British Pharmacopoeia.
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Hospital and tender supplies
Injectable antibiotics, IV fluids, anaesthetics and analgesics in hospital packs for national and regional tenders.
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Food supplements
Vitamins, minerals, omega-3, probiotics and protein products for brands selling supplements across the EU.
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Traditional herbal products
Herbal tablets, capsules and powders for the traditional herbal registration route or for sale as supplements.
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Cosmetics
Creams, washes, soaps and shampoos with INCI ingredient lists and the formula data your responsible person needs.
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Veterinary medicines
Injectables, oral liquids and water-soluble powders for livestock, poultry and pets, for importers with the veterinary authorisation.
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Intermediates for manufacturers
DC granules and coated pellets for European tablet and capsule makers.
Medicine regulators in Europe
Each country registers medicines through its own regulator. These are the authorities in the largest markets; we prepare dossiers in the formats they expect.
European Union
Western and Southern Europe
Central and Eastern Europe
- Poland
- Office for Registration of Medicinal Products (URPL)
- Romania
- National Agency for Medicines and Medical Devices (ANMDMR)
- Czech Republic
- State Institute for Drug Control (SÚKL)
- Hungary
- National Institute of Pharmacy and Nutrition (OGYÉI)
- Bulgaria
- Bulgarian Drug Agency (BDA)
Outside the EU
- United Kingdom
- Medicines and Healthcare products Regulatory Agency (MHRA)
- Switzerland
- Swissmedic
- Türkiye
- Turkish Medicines and Medical Devices Agency (TİTCK)
- Serbia
- Medicines and Medical Devices Agency of Serbia (ALIMS)
- Ukraine
- State Expert Centre of the Ministry of Health (SEC)
In the EU a medicine is authorised either centrally, by the EMA and the European Commission, or nationally, through the decentralised or mutual recognition procedures that most generics use. The authorisation is held by a company established in the EU or EEA. The UK and Switzerland run their own systems. Rules differ by country, so check with your authority.
How registration usually works
Timelines vary widely by route and country, from many months to more than a year, so many importers start with a few products and add more as the first ones are authorised.
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01
Appoint an authorisation holder
A medicine is authorised to a company established in the EU or EEA, usually the importer or distributor, which holds the authorisation and answers to the authority.
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02
Choose the route
Centralised, decentralised, mutual recognition or national, depending on the product and the countries you want to sell in.
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03
Submit the dossier
We provide the manufacturing and quality data in the CTD format, the GMP certificate and samples, and your team files the dossier, with the data the route requires for a generic, such as bioequivalence.
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04
Inspection and release
The authority may inspect the manufacturing site or rely on its GMP certification, and an importer in the EU certifies each batch before it goes on sale.
Made for European 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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Stability for Europe
Stability studies at 25 °C and 60% relative humidity (climate Zone II), the condition European authorities ask for, so the shelf life on the pack is valid.
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Labels in each language
Cartons and leaflets in the language of each country, following the EU product information templates, with the authorisation number and batch details.
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Braille and safety features
Braille for the product name and strength on the carton, and room on the pack for the unique identifier and anti-tampering device that prescription medicines carry.
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Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities your customers buy.
Shipping to Europe
Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your importer and customs broker need.
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North and West Europe
Rotterdam, Antwerp, Hamburg and Felixstowe, with onward road freight
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Southern Europe
Genoa, Barcelona, Valencia and Piraeus
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Air freight
Frankfurt, Amsterdam and London, for urgent orders and samples
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Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin, COA and batch documents for release in the EU
Questions about supplying Europe
Something else? Email [email protected].
Do you export medicines to Europe?
Yes. Progene Pharma manufactures generic medicines in an EU-GMP and WHO-GMP certified facility and supplies them to importers, distributors and marketing authorisation holders in the EU, the United Kingdom, Switzerland and the wider region.
Is your facility EU-GMP certified?
Yes. The facility where we manufacture holds EU-GMP certification, as well as WHO-GMP and ISO. We send a copy of the certificate with the dossier. Tell us your authority and we will confirm which certification applies to your order.
Who holds the marketing authorisation?
A company established in the EU or EEA, usually the importer or distributor. Progene Pharma prepares the manufacturing and quality documents and answers the authority's questions with you, but does not hold the authorisation.
Can you supply a dossier in the CTD format?
Yes. Progene Pharma provides the manufacturing and quality data in the CTD format, with stability data for climate Zone II, the GMP certificate and samples. For a generic, your authorisation also needs data such as bioequivalence, depending on the route.
Who releases the batches in the EU?
An importer in the EU, which holds a manufacturing or importation authorisation, tests and certifies each batch before it is placed on the market. We ship with the batch documents and the Certificate of Analysis it needs.
Can the packs carry Braille and the safety features?
Yes. We design cartons with Braille for the name and strength and space for the unique identifier and anti-tampering device, to match your authorisation. The serialisation itself is added to match the system your market uses.
Do you supply food supplements and cosmetics for Europe?
Yes. Progene Pharma makes supplements, herbal products and cosmetics under your brand, with ingredient lists and documents for your responsible person or notification. Rules on claims and ingredients differ by country, so check with your authority.
How are orders shipped to Europe?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to ports such as Rotterdam, Antwerp, Hamburg, Genoa and Piraeus, or by air for urgent orders, on FOB, CFR or CIF terms.
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.
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