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Manufacturing facility

Pharmathen International S.A.

A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.

Country
Greece
Registered address
Industrial Park Sapes Rodopi Prefecture, Block No 5, Sapes, 69300, Greece (GRC)
Operations here
analysismanufacturepack
FDA identifiers
FEI 3009961173 · DUNS 503272186

Recent inspection flagged official action

FDA classified an inspection here as OAI (official action indicated) within the last two years — the strongest public warning signal a facility gets. This plant is listed on labels for 3 drugs. A supply problem here can ripple to all of them.

FDA inspection history

Outcomes of closed FDA inspections at this site (drug and biologic program areas).

  • OAIDrug Quality Assurance2025-11-21
  • VAIDrug Quality Assurance2021-12-09

Drugs this plant is listed as making

3 distinct drugs across 13 products name this site in their FDA label.

Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.