Pharmaceutical exports to Ukraine, ready for State Expert Centre registration

Yes. Progene Pharma manufactures generic medicines in an EU-GMP and WHO-GMP certified facility and supplies them to marketing authorisation holders, importers, wholesalers and tender suppliers in Ukraine.

Yes. Progene Pharma prepares the manufacturing and quality documents an application needs: the CTD dossier, stability data, the GMP certificate and the manufacturing details. Your Ukrainian company files the application, and we answer SEC's questions with you.

Yes. Ukraine registers a medicine through a company established in Ukraine that holds the right licences, usually the importer or distributor. Check the current requirements with the State Expert Centre.

No. Ukraine runs its own registration system, aligned with European standards, so a medicine needs a Ukrainian registration. Documents prepared for a European dossier can often be reused, and we prepare them to fit both. Check the current requirements with the State Expert Centre.

The usual set is the CTD dossier, stability data at European conditions, the manufacturer's GMP certificate and manufacturing details, bioequivalence data for most generics, the active substance master file details and product information. SEC updates its requirements from time to time, so confirm the current list with SEC or your regulatory consultant. We tell you what we can provide with your quotation.

Conditions at the ports, with banks and on the roads change quickly. We confirm routes, permits and payment arrangements with the buyer before we accept an order, and we plan each shipment individually.

Yes. We supply hospital and programme packs with the full document set that international organisations expect, including the GMP evidence, the COA and the stability data. Send us the specification and we will confirm what we can provide.

Cargo usually arrives by sea at a port in Poland or Romania and continues by road or rail across the border. Your customs broker handles import, and we confirm the schedule with your quotation.

Ukrainian text, the registration number, batch number, manufacture and expiry dates, storage conditions and the other details the centre requires. We prepare the artwork to match your registration and you approve a proof before printing.

Yes. Progene Pharma tests products at 25 °C and 60% relative humidity (climate Zone II), the condition European authorities ask for, and packs them in moisture-resistant blisters or bottles, so the shelf life on the pack is valid.

Yes. Progene Pharma supplies tender packs and the product documents tenders usually ask for. Tell us the tender requirements and we will confirm what we can provide.

Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Gdańsk, Gdynia or Constanța, with onward road or rail freight, or by air to Warsaw for urgent orders, on FOB, CFR or CIF terms. We confirm the schedule with your quotation.

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.