Iran produces most of its own finished medicines, but the active pharmaceutical ingredients (APIs) behind them are largely imported, with China and India the main sources. For an API manufacturer this makes Iran a market of many industrial buyers rather than a single tender, and the buyers are technical: their quality and regulatory teams decide before purchasing does.

What buyers check first

  • The API's regulatory file: an open part of a DMF, a CEP or an equivalent technical package, so the Iranian manufacturer can add the source to its own product registration at IFDA.
  • GMP certificate of the manufacturing site, current and matching the site that will make the batches.
  • Certificate of analysis against the pharmacopoeia the buyer works to (USP, EP or BP), and samples for testing.
  • Stability data and the retest period.
  • Route of synthesis and impurity profile, including residual solvents and, increasingly, nitrosamine risk assessment.

Why a new source takes time

Changing or adding an API source is a variation to the finished product's registration. The buyer must test samples, often run trial batches and stability, and file the change with IFDA before commercial orders follow. Suppliers that send a complete technical package at the start shorten this step considerably.

How the import works

APIs are imported by companies licensed by IFDA for pharmaceutical raw materials. The importer obtains the import permit for each consignment against the documents above, arranges customs clearance and quality release, and delivers to the manufacturer. Controlled substances and precursors need additional licences.

What helps a supplier win business

  • A clear specification sheet and CoA in English, matched to the pharmacopoeia the buyer uses.
  • Willingness to share the open part of the DMF and to answer quality questionnaires.
  • Consistent quality across batches, with change notifications sent in advance.
  • An importer in Iran who knows both the buyer's technical requirements and the IFDA process.

Hanpars sources APIs for manufacturers in Iran from GMP producers in China, India, Türkiye and Europe, and imports them under its IFDA licence. Browse the API range, read the guide for Chinese exporters, or contact us if you manufacture APIs and want to supply Iran.